Table 4.
Adverse Events Occurring in Greater than 5% of Study Participants
| System Organ Class Preferred Term |
Davunetide (N=156) n (%) |
Placebo (N=156) n (%) |
Total (N=312) n (%) |
|---|---|---|---|
| Participants with at Least One Event | 145 (92.9) | 148 (94.9) | 293 (93.9) |
| Eye disorders | 30 (19.2) | 20 (12.8) | 50 (16.0) |
| Gastrointestinal disorders | 37 (23.7) | 48 (30.8) | 85 (27.2) |
| Constipation | 12 (7.7) | 12 (7.7) | 24 (7.7) |
| Dysphagia | 8 (5.1) | 10 (6.4) | 18 (5.8) |
| General disorders and administration site conditions | 24 (15.4) | 27 (17.3) | 51 (16.3) |
| Infections and infestations | 61 (39.1) | 68 (43.6) | 129 (41.3) |
| Urinary tract infection | 18 (11.5) | 31 (19.9) | 49 (15.7) |
| Nasopharyngitis | 7 (4.5) | 11 (7.1) | 18 (5.8) |
| Injury, poisoning and procedural complications | 84 (53.8) | 86 (55.1) | 170 (54.5) |
| Fall | 58 (37.2) | 56 (35.9) | 114 (36.5) |
| Skin laceration | 26 (16.7) | 28 (17.9) | 54 (17.3) |
| Contusion | 6 (3.8) | 16 (10.3) | 22 (7.1) |
| Investigations | 31 (19.9) | 22 (14.1) | 53 (17.0) |
| Metabolism and nutrition disorders | 14 (9.0) | 7 (4.5) | 21 (6.7) |
| Musculoskeletal and connective tissue disorders | 35 (22.4) | 43 (27.6) | 78 (25.0) |
| Nervous system disorders | 40 (25.6) | 62 (39.7) | 102 (32.7) |
| Dizziness | 6 (3.8) | 12 (7.7) | 18 (5.8) |
| Progressive supranuclear palsy, worsening | 6 (3.8) | 11 (7.1) | 17 (5.4) |
| Psychiatric disorders | 31 (19.9) | 47 (30.1) | 78 (25.0) |
| Depression | 9 (5.8) | 12 (7.7) | 21 (6.7) |
| Insomnia | 6 (3.8) | 11 (7.1) | 17 (5.4) |
| Renal and urinary disorders | 18 (11.5) | 20 (12.8) | 38 (12.2) |
| Respiratory, thoracic and mediastinal disorders | 77 (49.4) | 61 (39.1) | 138 (44.2) |
| Epistaxis | 18 (11.5) | 13 (8.3) | 31 (9.9) |
| Cough | 12 (7.7) | 12 (7.7) | 24 (7.7) |
| Rhinorrhea | 15 (9.6) | 8 (5.1) | 23 (7.4) |
| Nasal congestion | 18 (11.5) | 3 (1.9) | 21 (6.7) |
| Nasal mucosal disorder | 9 (5.8) | 8 (5.1) | 17 (5.4) |
| Nasal discomfort | 15 (9.6) | 1 (0.6) | 16 (5.1) |
| Skin and subcutaneous tissue disorders | 18 (11.5) | 21 (13.5) | 39 (12.5) |
| Vascular disorders | 10 (6.4) | 10 (6.4) | 20 (6.4) |
Adverse events leading to study medication discontinuation in greater than two individuals are shown in bold.