Table 2.
Adverse drug reactions in participants receiving LY3056480 for SNHL
| System Organ Class (term) | Event | LY3056480 |
|---|---|---|
| N = 59 | ||
| n (%) | ||
| Cardiac disorders | Sinus bradycardia | 1 (2%) |
| Ear and labyrinth disorders | Ear discomfort | 14 (24%) |
| Ear pain | 13 (22%) | |
| Hypoacusis | 16 (27%) | |
| Dysacusis | 1 (2%) | |
| Tinnitus | 27 (46%) | |
| Ear congestion | 12 (20%) | |
| External ear pain | 1 (2%) | |
| Ear pruritus | 1 (2%) | |
| Vertigo | 1 (2%) | |
| Gastrointestinal disorders | Nausea | 2 (3%) |
| Hypoaesthesia oral | 3 (5%) | |
| Dry mouth | 1 (2%) | |
| Tongue dry | 1 (2%) | |
| Abdominal discomfort | 2 (3%) | |
| Oral pruritus | 2 (3%) | |
| Noninfective gingivitis | 1 (2%) | |
| General disorders and administration site conditions | Injection site pain | 49 (83%) |
| Injection site pruritus | 3 (5%) | |
| Feeling abnormal | 1 (2%) | |
| Pain | 2 (3%) | |
| Injection site discomfort | 1 (2%) | |
| Injury, poisoning and procedural complications | Procedural pain | 15 (25%) |
| Procedural dizziness | 7 (12%) | |
| Post procedural discomfort | 1 (2%) | |
| Investigations | Acoustic stimulation tests abnormal | 1 (2%) |
| Blood pressure increased | 1 (2%) | |
| Musculoskeletal and connective tissue disorders | Pain in jaw | 6 (10%) |
| Arthralgia | 1 (2%) | |
| Nervous system disorders | Headache | 5 (8%) |
| Dysgeusia | 4 (7%) | |
| Dizziness | 13 (22%) | |
| Dizziness postural | 1 (2%) | |
| Hypoaesthesia | 1 (2%) | |
| Respiratory, thoracic and mediastinal disorders | Dry throat | 1 (2%) |
| Oropharyngeal pain | 5 (8%) | |
| Throat irritation | 2 (3%) | |
| Skin | Rash | 1 (2%) |
| Acne | 1 (2%) |