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%) |
