Table 5.
Summary of adverse events
| Event | Safety evaluable population (n = 797) | ||
|---|---|---|---|
| Placebo (n = 266) |
Gantenerumab 105 mg (n = 271) |
Gantenerumab 225 mg (n = 260) |
|
| Any adverse event | 250 (94.0%) | 241 (88.9%) | 240 (92.3%) |
| Any serious adverse event | 55 (20.7%) | 48 (17.7%) | 46 (17.7%) |
| Any death | 6 (2.3%) | 0 | 2 (0.8%) |
| Cardiac disorders | 24 (9.0%) | 26 (9.6%) | 22 (8.5%) |
| Ear and labyrinth disorders | 11 (4.1%) | 15 (5.5%) | 13 (5.0%) |
| Eye disorders | 20 (7.5%) | 16 (5.9%) | 23 (8.8%) |
| Gastrointestinal disorders | 65 (24.4%) | 64 (23.6%) | 63 (24.2%) |
| Diarrhea | 14 (5.3%) | 15 (5.5%) | 15 (5.8%) |
| General disorders and administration site conditions | 44 (16.5%) | 78 (28.8%) | 90 (34.6%) |
| Injection site erythema | 3 (1.1%) | 29 (10.7%) | 35 (13.5%) |
| Fatigue | 8 (3.0%) | 7 (2.6%) | 15 (5.8%) |
| Infections and infestations | 110 (41.4%) | 110 (40.6%) | 119 (45.8%) |
| Nasopharyngitis | 17 (6.4%) | 30 (11.1%) | 20 (7.7%) |
| Urinary tract infection | 26 (9.8%) | 16 (5.9%) | 22 (8.5%) |
| Upper respiratory tract infection | 11 (4.1%) | 13 (4.8%) | 18 (6.9%) |
| Influenza | 13 (4.9%) | 13 (4.8%) | 15 (5.8%) |
| Bronchitis | 10 (3.8%) | 10 (3.7%) | 14 (5.4%) |
| Injury, poisoning, and procedural complications | 73 (27.4%) | 65 (24.0%) | 59 (22.7%) |
| Fall | 28 (10.5%) | 23 (8.5%) | 28 (10.8%) |
| Investigations | 40 (15.0%) | 35 (12.9%) | 48 (18.5%) |
| Metabolism and nutrition disorders | 23 (8.6%) | 21 (7.7%) | 24 (9.2%) |
| Musculoskeletal and connective tissue disorders | 82 (30.8%) | 72 (26.6%) | 72 (27.7%) |
| Back pain | 26 (9.8%) | 16 (5.9%) | 25 (9.6%) |
| Arthralgia | 20 (7.5%) | 12 (4.4%) | 16 (6.2%) |
| Musculoskeletal pain | 15 (5.6%) | 6 (2.2%) | 5 (1.9%) |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 20 (7.5%) | 16 (5.9%) | 21 (8.1%) |
| Nervous system disorders | 123 (46.2%) | 126 (46.5%) | 127 (48.8%) |
| Headache | 36 (13.5%) | 34 (12.5%) | 25 (9.6%) |
| Dizziness | 21 (7.9%) | 21 (7.7%) | 27 (10.4%) |
| Psychiatric disorders | 76 (28.6%) | 65 (24.0) | 73 (28.1%) |
| Depression | 14 (5.3%) | 23 (8.5%) | 25 (9.6%) |
| Anxiety | 19 (7.1%) | 20 (7.4%) | 16 (6.2%) |
| Renal and urinary disorders | 19 (7.1%) | 21 (7.7%) | 22 (8.5%) |
| Reproductive system and breast disorders | 12 (4.5%) | 14 (5.2%) | 15 (5.8%) |
| Respiratory, thoracic, and mediastinal disorders | 32 (12.0%) | 29 (10.7%) | 33 (12.7%) |
| Skin and subcutaneous tissue disorders | 31 (11.7%) | 39 (14.4%) | 39 (15.0%) |
| Surgical and medical procedures | 21 (7.9%) | 18 (6.6%) | 18 (6.9%) |
| Vascular disorders | 33 (12.4%) | 19 (7.0%) | 30 (11.5%) |
| Hypertension | 18 (6.8%) | 11 (4.1%) | 19 (7.3%) |
Events with an incidence of at least 5% in any treatment group are shown