{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"518"},{"groupId":"OG001","value":"170"},{"groupId":"OG002","value":"30"}]}],"title":"TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"9"}]}],"title":"Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"284"},{"groupId":"OG001","value":"79"},{"groupId":"OG002","value":"11"}]}],"title":"Grade 3/4/5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"451"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"19"}]}],"title":"Drug-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"2"}]}],"title":"Serious Drug-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"6"}]}],"title":"Drug-related grade 3/4/5 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"}]}],"title":"TEAE leading to reduction of 177Lu-PSMA-617"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"1"}]}],"title":"TEAE leading to reduction of BSC/BSoC"},{"categories":[{"measurements":[{"groupId":"OG000","value":"85"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"4"}]}],"title":"TEAE leading to interruption of 177Lu-PSMA-617"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"1"}]}],"title":"TEAE leading to interruption of BSC/BSoC"},{"categories":[{"measurements":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"}]}],"title":"TEAE leading to discontinuation of 177Lu-PSMA-617"},{"categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"0"}]}],"title":"TEAE leading to discontinuation of BSC/BSoC"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"2"}]}],"title":"Fatal TEAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"529"},{"groupId":"OG001","value":"205"},{"groupId":"OG002","value":"30"}],"units":"Participants"}],"description":"In the Main Study, \"randomized treatment\" refers to the investigational arm (AAA617+BSC/BSoC) and the control arm (BSC/BSoC). In the sub-study, \"study treatment\" refers to the investigational arm (AAA617+BSC/BSoC) without randomization:\n\n1. A randomized treatment-emergent adverse event (TEAE) is any adverse event that occurs from the start of randomized treatment to 30 days after the last administration of randomized treatment or prior to the initiation of subsequent anticancer treatment.\n2. A study treatment-emergent adverse event (TEAE) is any adverse event that occurs from the start of study treatment to 30 days after the last administration of study treatment or prior to the initiation of subsequent anticancer treatment.\n\nThe distribution of randomized/study treatment-emergent adverse events (TEAEs) was done via the analysis of frequencies for TEAEs and Serious Adverse Event (TESAEs), through the monitoring of relevant clinical and laboratory safety parameters.","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"},{"description":"non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study","id":"OG002","title":"Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)"}],"paramType":"NUMBER","populationDescription":"FAS Safety Analysis Set. A patient with multiple grades for an AE is only counted under the maximum grade. Drug-related is related to any study drug (177Lu-PSMA-617 or BSC/BSoC). Study treatment refers to 177Lu-PSMA-617+BSC/BSoC.","reportingStatus":"POSTED","timeFrame":"From randomization till 30 days safety follow-up, assessed up to 66 months (Final Analysis cut-off date = 14-Dec-2023)","title":"Number of Participants With Randomized/Study Treatment-emergent Adverse Events (TEAE)","type":"SECONDARY","unitOfMeasure":"Participants"}