8 After a median follow-up of 17.9 months, treatment 4 discontinuations were similar between both arms. Discontinuations due to adverse events occurred in 8.9% of patients in the darolutamide arm vs 8.7% of patients in the placebo arm. Discontinuations due to metastasis occurred in 11.7% vs 23.3% of patients; and discontinuations due to investigator judgment occurred in 5.7% vs 16.4% of patients, in the darolutamide vs placebo arms, respectively. Discontinuations due to protocol deviation and to other reasons unspecied occurred in 1.4% vs 1.3% and 0.6% vs 0.4% in the darolutamide vs placebo arm, respectively. Additionally, 7.1% vs 14.1% of patients in the darolutamide vs placebo arm respectively decided not to continue trial participation. It should be noted that one person in the darolutamide arm was randomized but did not 2 receive treatment. A total of 55 deaths (Grade 5 event) occurred during the trial with 3.9% of deaths occurring in the darolutamide arm versus 3.2% 3 occurring in the placebo arm. See Table 5 below. The incidence of discontinuations due to AEs was unchanged from the primary analysis while the incidences of serious AEs and Grade 5 AEs between the treatment groups during the double- blind period were comparable with the primary 2,3 analysis (Table 5). In the placebo-darolutamide crossover group, 70.0% experienced an AE and 4.7% experienced an AE leading to discontinuation 2,3 (Table 5). 2,3 Table 5. Summary of Treatment-Emergent Adverse Events (TEAEs) Daro, darolutamide. In line with the primary analysis, fatigue was the only AE present in more than 10% of patients during the double-blind period (13.2% in the darolutamide group and 8.3% in the placebo group) while the incidence of 2 all other AEs that occurred in ≥5% of patients was generally similar between groups. AEs of interest are 2 presented in Table 6. ARAMIS trial TEAEs Any AE, n (%) Grade 3 or 4 Grade 5 Serious Leading to permanent discontinuation of study drug Daro + ADT N=954 794 (83.2) 236 (24.7) 37 (3.9) 237 (24.8) 85 (8.9) Placebo + ADT N=554 426 (76.9) 108 (19.5) 18 (3.2) 111 (20.0) 48 (8.7) Daro + ADT (double blind period) N=954 818 (85.7) 251 (26.3) 38 (4.0) 249 (26.1) 85 (8.9) Placebo + ADT (double blind period) N=554 439 (79.2) 120 (21.7) 19 (3.4) 121 (21.8) 48 (8.7) Placebo-Daro Crossover N=170 119 (70.0) 27 (15.9) 2 (1.2) 26 (15.3) 8 (4.7) Final Analysis Primary Analysis UROLOGY, URO-ONCOLOGY AND SEXOLOGY UPDATE
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