{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.037","value":"-0.59"},{"groupId":"OG001","spread":"2.404","value":"0.21"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"311"},{"groupId":"OG001","value":"100"}],"units":"Participants"}],"title":"Cycle 2, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.924","value":"-0.62"},{"groupId":"OG001","spread":"2.033","value":"0.02"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"52"}],"units":"Participants"}],"title":"Cycle 3, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.017","value":"-0.42"},{"groupId":"OG001","spread":"2.383","value":"0.26"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"32"}],"units":"Participants"}],"title":"Cycle 4, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.957","value":"-0.49"},{"groupId":"OG001","spread":"3.144","value":"0.55"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"183"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"Cycle 5, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.897","value":"-0.41"},{"groupId":"OG001","spread":"2.740","value":"0.10"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"162"},{"groupId":"OG001","value":"13"}],"units":"Participants"}],"title":"Cycle 6, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.011","value":"-0.48"},{"groupId":"OG001","spread":"1.585","value":"-0.32"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"Cycle 7, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.759","value":"-0.18"},{"groupId":"OG001","spread":"2.205","value":"-1.10"}]}],"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":"2.157","value":"-0.70"},{"groupId":"OG001","spread":"1.780","value":"0.13"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"title":"Cycle 9, Week 1, Day 1 change from BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.513","value":"0.02"},{"groupId":"OG001","spread":"1.768","value":"0.50"}]}],"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":"0.956","value":"-0.40"},{"groupId":"OG001","spread":"1.768","value":"0.75"}]}],"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":"0.354","value":"-1.00"}]}],"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":"-0.75"}]}],"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":"2.415","value":"0.46"},{"groupId":"OG001","spread":"2.405","value":"0.50"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"End of Treatment (EoT) change from BL"}],"denoms":[{"counts":[{"groupId":"OG000","value":"385"},{"groupId":"OG001","value":"196"}],"units":"Participants"}],"description":"The BPI-SF is a generic pain assessment tool used in research and practice for pain assessment in musculoskeletal conditions. The higher the BPI-SF score, the worse the pain. The BPI-SF consists of 4 questions regarding pain intensity (worst pain intensity, least pain intensity, average pain intensity and pain right now), 2 questions on the use of analgesics, and 7 questions on how the level pain has interfered with the subject's life (General Activity, Mood, Walking Ability, Normal Work, Relations with other people, Sleep, Enjoyment of Life). Intensity items consist of an 11-response rating scale scored from 0 (\"No Pain\") to 10 (\"Pain As Bad As You Can Imagine\"). BPI-SF Pain intensity is the mean of non-missing items of the 4 individual scales, if there are 3 or more items not missing; otherwise this scale is set to missing.","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 BPI-SF (Brief-Pain Inventory - Short Form) Pain Intensity Scale","type":"SECONDARY","unitOfMeasure":"Score on a scale"}