Urology, Uro-oncology and Sexology Update

4 Patient Baseline Characteristics and Demographics Patient demographics (Table 1) and baseline clinical characteristics (Table 2) were well-balanced between 2,3 the study groups. 3 Table 1. ARAMIS: Patient Demographics Age, median, years Age group, n (%) <65 65 - 74 75 – 84 ≥85 Race, n (%) *Asian Black or African American Other White Weight N Missing, n Median, kg Geographical region, n (%) North America Asia Pacic Rest of the world Darolutamide N=95574.0 113 (11.8) 373 (39.1) 384 (40.2) 85 (8.9) 122 (12.8) 28 (2.9) 9 (0.9) 760 (79.6) 953 2 82.40 108 (11.3) 119 (12.5) 728 (76.2) Placebo N=55474.0 84 (15.2) 216 (39.0) 209 (37.7) 45 (8.1) 71 (12.8) 24 (4.3) 6 (1.1) 434 (78.3) 552 2 82.00 76 (13.7) 67 (12.1) 411 (74.2) Total N=150974.0 197 (13.1) 589 (39.0) 593 (39.3) 130 (8.6) 193 (12.8) 52 (3.4) 15 (1.0) 1194 (79.1) 1505 4 82.00 184 (12.2) 186 (12.3) 1139 (75.5) Darolutamide N=955 n (%) 667 (69.8) 4.84 (4.39) 18.7 (9.0) 924 (96.8) 650 (68.1) 305 (31.9) 27 (2.8) 217 (22.7) 711 (74.5) 177 (18.5) 727 (76.1) 51 (5.3) 792 (82.9) 163 (17.1) Placebo N=554 n (%) 371 (67.0) 4.89 (4.65) 19.8 (9.7) 522 (94.2) 391 (70.6) 163 (29.4) 17 (3.1) 142 (25.6) 395 (71.3) 103 (18.6) 420 (75.8) 31 (5.6) 396 (71.5) 158 (28.5) Total N=1509 n (%) 1038 (68.8) 4.86 (4.45) 19.1 (9.3) 1446 (95.8) 1041 (69.0) 468 (31.0) 44 (2.9) 359 (23.8) 1106 (73.3) 280 (18.6) 1147 (76.0) 82 (5.4) 1188 (78.7) 321 1.3) 3 Table 2. ARAMIS: Patient Characteristics Baseline PSADT ≤6 months, n (%) PSADT, months, mean (median) PSA, ng/mL, mean (median) No baseline osteoclast- target therapy, n (%) ECOG PS, n (%) 0 1 Gleason total score (Factor1 + Factor2), n (%) Missing <7 ≥7 Prior hormonal therapy, n (%)103 (18.6) 1 ≥2 Not applicable* Baseline presence of regional pathological lymph nodes by central imaging review, n (%) No Yes UROLOGY, URO-ONCOLOGY AND SEXOLOGY UPDATE

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