MedDRA* description | rhNGF 20 µg/mL N=20 n (%) (n AE) | rhNGF 4 µg/mL N=20 n (%) (n AE) | Overall N=40 n (%) (n AE) | |||
SOC | AEs n | Subjects n (%) | AEs n | Subjects n (%) | AEs n | Subjects n (%) |
PT | ||||||
All SOCs | 36 | 14 (70%) | 65 | 15 (75%) | 101 | 29 (72.5%) |
Eye disorders | 32 | 12 (60%) | 46 | 15 (75%) | 78 | 27 (67.5%) |
Abnormal sensation in eye | 4 | 4 (20%) | 9 | 8 (40%) | 13 | 12 (30%) |
Eye pain | 7 | 5 (25%) | 7 | 6 (30%) | 14 | 11 (27.5%) |
Eye irritation | 6 | 3 (15%) | 7 | 7 (35%) | 13 | 10 (25%) |
Eye pruritus | 4 | 2 (10%) | 5 | 5 (25%) | 9 | 7 (17.5%) |
Vision blurred | 4 | 3 (15%) | 2 | 2 (10%) | 6 | 5 (12.5%) |
Foreign body sensation in eyes | 0 | 0 | 4 | 4 (20%) | 4 | 4 (10%) |
Photophobia | 2 | 1 (5%) | 3 | 3 (15%) | 5 | 4 (10%) |
Lacrimation increased | 0 | 0 | 3 | 3 (15%) | 3 | 3 (7.5%) |
Visual impairment | 1 | 1 (5%) | 1 | 1 (5%) | 2 | 2 (5%) |
Asthenopia | 1 | 1 (5%) | 0 | 0 | 1 | 1 (2.5%) |
Erythema of eyelid | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Eye discharge | 1 | 1 (5%) | 0 | 0 | 1 | 1 (2.5%) |
Eye disorder | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Eyelid pain | 1 | 1 (5%) | 0 | 0 | 1 | 1 (2.5%) |
Eyelid sensory disorder | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Ocular discomfort | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Ocular hyperaemia | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Vitreous detachment | 1 | 1 (5%) | 0 | 0 | 1 | 1 (2.5%) |
Infections and infestations | 2 | 2 (10%) | 5 | 5 (25%) | 7 | 7 (17.5%) |
Rhinitis | 0 | 0 | 2 | 2 (10%) | 2 | 2 (5%) |
Conjunctivitis bacterial | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Herpes simplex | 1 | 1 (5%) | 0 | 0 | 1 | 1 (2.5%) |
Nasopharyngitis | 1 | 1 (5%) | 0 | 0 | 1 | 1 (2.5%) |
Sinusitis | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Urinary tract infection | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Nervous system disorders | 1 | 1 (5%) | 9 | 5 (25%) | 10 | 6 (15%) |
Headache | 0 | 0 | 9 | 5 (25%) | 9 | 5 (12.5%) |
Migraine | 1 | 1 (5%) | 0 | 0 | 1 | 1 (2.5%) |
Musculoskeletal and connective tissue disorders | 0 | 0 | 2 | 2 (10%) | 2 | 2 (5%) |
Back pain | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Neck pain | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Ear and labyrinth disorders | 1 | 1 (5%) | 0 | 0 | 1 | 1 (2.5%) |
Tinnitus | 1 | 1 (5%) | 0 | 0 | 1 | 1 (2.5%) |
Gastrointestinal disorders | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Flatulence | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Injury, poisoning and procedural complications | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Concussion | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
Fall | 0 | 0 | 1 | 1 (5%) | 1 | 1 (2.5%) |
AE, adverse events; MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SOC, system organ class; TEAEs, treatment-emerged adverse events.