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Table 5 Summary of adverse events

From: A phase III randomized trial of gantenerumab in prodromal Alzheimer’s disease

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%)
  1. Events with an incidence of at least 5% in any treatment group are shown