Table 2. Summary of Adverse Events (AEs) in Safety-Evaluable Cohort.
| Characteristic | No. (%) | |||
|---|---|---|---|---|
| Placebo (n = 130) | Semorinemab | |||
| 1500 mg (n = 89) | 4500 mg (n = 132) | 8100 mg (n = 90) | ||
| Any AE | 121 (93.1) | 79 (88.8) | 124 (93.9) | 83 (92.2) |
| Any serious AE | 14 (10.8) | 17 (19.1) | 17 (12.9) | 16 (17.8) |
| Discontinued due to AE | 8 (6.2) | 5 (5.6) | 6 (4.5) | 3 (3.3) |
| Grade ≥3 AE | 18 (13.8) | 22 (24.7) | 18 (13.6) | 16 (17.8) |
| Deaths | 2 (1.5) | 0 (0.0) | 1 (0.8) | 1 (1.1) |
| AEs reported in ≥5% | ||||
| Fall | 23 (17.7) | 14 (15.7) | 23 (17.4) | 8 (8.9) |
| Nasopharyngitis | 11 (8.5) | 5 (5.6) | 18 (13.6) | 12 (13.3) |
| Infusion-related reaction | 6 (4.6) | 10 (11.2) | 11 (8.3) | 6 (6.7) |
| Arthralgia | 8 (6.2) | 6 (6.7) | 10 (7.6) | 8 (8.9) |
| Hypertension | 7 (5.4) | 4 (4.5) | 14 (10.6) | 5 (5.6) |
| Urinary tract infection | 10 (7.7) | 5 (5.6) | 10 (7.6) | 6 (6.7) |
| Upper respiratory tract infection | 15 (11.5) | 6 (6.7) | 7 (5.3) | 5 (5.6) |
| Back pain | 8 (6.2) | 5 (5.6) | 9 (6.8) | 6 (6.7) |
| Dizziness | 12 (9.3) | 5 (5.6) | 6 (4.5) | 7 (7.8) |
| Anxiety | 3 (2.3) | 10 (11.2) | 6 (4.6) | 6 (6.7) |
| Diarrhea | 4 (3.1) | 5 (5.6) | 10 (7.6) | 4 (4.4) |
| Headache | 10 (7.7) | 2 (2.3) | 8 (6.1) | 6 (6.7) |
| Nausea | 0 (0) | 9 (10.1) | 8 (6.1) | 4 (4.4) |
| Cough | 4 (3.1) | 6 (6.7) | 7 (5.3) | 5 (5.6) |
| Depression | 5 (3.8) | 5 (5.6) | 7 (5.3) | 5 (5.6) |
| Agitation | 2 (1.5) | 5 (5.6) | 6 (4.5) | 4 (4.4) |
| Insomnia | 3 (2.3) | 2 (2.2) | 4 (3.0) | 5 (5.6) |
| Blood pressure increased | 2 (1.5) | 1 (1.1) | 8 (6.1) | 2 (2.2) |
| Fatigue | 2 (1.5) | 1 (1.1) | 4 (3.0) | 5 (5.6) |
| Skin laceration | 4 (3.1) | 6 (6.7) | 2 (1.5) | 0 (0.0) |