{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.17693","value":"0.0221"},{"groupId":"OG001","spread":"0.24973","value":"-0.0897"}]}],"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":"0.18817","value":"0.0297"},{"groupId":"OG001","spread":"0.14155","value":"-0.0331"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"53"}],"units":"Participants"}],"title":"Cycle 3, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.17713","value":"0.0292"},{"groupId":"OG001","spread":"0.23752","value":"-0.0818"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"32"}],"units":"Participants"}],"title":"Cycle 4, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.16827","value":"0.0398"},{"groupId":"OG001","spread":"0.28633","value":"-0.0673"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"180"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"Cycle 5, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.17950","value":"0.0342"},{"groupId":"OG001","spread":"0.17842","value":"-0.0110"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"13"}],"units":"Participants"}],"title":"Cycle 6, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.16127","value":"0.0252"},{"groupId":"OG001","spread":"0.09081","value":"-0.0088"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Cycle 7, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.18017","value":"0.0285"},{"groupId":"OG001","spread":"0.14964","value":"-0.0296"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"title":"Cycle 8, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.17447","value":"0.0100"},{"groupId":"OG001","spread":"0.08167","value":"0.0087"}]}],"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":"0.15764","value":"0.0134"},{"groupId":"OG001","spread":"0.09263","value":"-0.0655"}]}],"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":"0.16858","value":"0.0464"},{"groupId":"OG001","spread":"0.19940","value":"0.0250"}]}],"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":"0.13833","value":"0.1118"}]}],"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":"0.0640"}]}],"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":"0.22698","value":"-0.0939"},{"groupId":"OG001","spread":"0.21223","value":"-0.0900"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"85"}],"units":"Participants"}],"title":"End of Treatment (EoT) change from BL"}],"denoms":[{"counts":[{"groupId":"OG000","value":"385"},{"groupId":"OG001","value":"196"}],"units":"Participants"}],"description":"The EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions. A utility score was obtained by using a weighted combination of the levels of the five dimension-scales. The weights were based on value sets which were country-specific for the U.K. Utility scores ranges from the lowest possible score for a living patient of -0.594 (when all responses are '5') to 1 (when all responses are '1').If a patient died, he was assigned a score of 0 on the date of death.","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 the European Quality of Life (EuroQol) - 5 Domain 5 Level Scale (EQ-5D-5L) Utility Score","type":"SECONDARY","unitOfMeasure":"Score on a scale"}