Table 3 Primary safety endpoint for the placebo-controlled period
Variable | Placebo (n = 214) | 125 mg q4w (n = 58) | 375 mg q12w (n = 58) | 600 mg q4w (n = 106) | 2,000 mg q4w (n = 214) | Total gosuranemab (n = 436) |
|---|---|---|---|---|---|---|
Any AE | 181 (84.6) | 50 (86.2) | 48 (82.8) | 94 (88.7) | 189 (88.3) | 381 (87.4) |
Treatment-relateda AEs | 47 (22.0) | 15 (25.9) | 12 (20.7) | 21 (19.8) | 50 (23.4) | 98 (22.5) |
SAEs | 26 (12.1) | 6 (10.3) | 6 (10.3) | 13 (12.3) | 25 (11.7) | 50 (11.5) |
Treatment-related SAEs | 2 (0.9) | 0 | 0 | 0 | 2 (0.9) | 2 (0.5) |
Drug withdrawal due to AEs | 11 (5.1) | 4 (6.9) | 2 (3.4) | 0 | 8 (3.7) | 14 (3.2) |
Study withdrawal due to AEs | 11 (5.1) | 2 (3.4) | 1 (1.7) | 0 | 6 (2.8) | 9 (2.1) |
Mortality events | 1 (0.5) | 1 (1.7) | 0 | 0 | 1 (0.5) | 2 (0.5) |
Infusion reactions | 79 (36.9) | 31 (53.4) | 23 (39.7) | 38 (35.8) | 75 (35.0) | 167 (38.3) |
AEs with incidence of ≥10% in any single treatment group | ||||||
Falls | 23 (10.7) | 7 (12.1) | 11 (19.0) | 20 (18.9) | 30 (14.0) | 68 (15.6) |
Nasopharyngitis | 22 (10.3) | 4 (6.9) | 6 (10.3) | 9 (8.5) | 24 (11.2) | 43 (9.9) |
Arthralgia | 14 (6.5) | 6 (10.3) | 7 (12.1) | 9 (8.5) | 19 (8.9) | 41 (9.4) |
Headache | 20 (9.3) | 1 (1.7) | 6 (10.3) | 11 (10.4) | 22 (10.3) | 40 (9.2) |
Diarrhea | 12 (5.6) | 11 (19.0) | 3 (5.2) | 6 (5.7) | 11 (5.1) | 31 (7.1) |
Constipation | 8 (3.7) | 6 (10.3) | 1 (1.7) | 2 (1.9) | 6 (2.8) | 15 (3.4) |
