Table 2

Number of subjects reporting and number of reported TEAEs by SOC and PT

MedDRA* descriptionrhNGF 20 µg/mL
N=20
n (%) (n AE)
rhNGF 4 µg/mL
N=20
n (%) (n AE)
Overall
N=40
n (%) (n AE)
SOCAEs nSubjects
n (%)
AEs nSubjects
n (%)
AEs nSubjects
n (%)
PT
All SOCs3614 (70%)6515 (75%)10129 (72.5%)
Eye disorders3212 (60%)4615 (75%)7827(67.5%)
 Abnormal sensation in eye44 (20%)98 (40%)1312 (30%)
 Eye pain75 (25%)76 (30%)1411 (27.5%)
 Eye irritation63 (15%)77 (35%)1310 (25%)
 Eye pruritus42 (10%)55 (25%)97 (17.5%)
 Vision blurred43 (15%)22 (10%)65 (12.5%)
 Foreign body sensation in eyes0044 (20%)44 (10%)
 Photophobia21 (5%)33 (15%)54 (10%)
 Lacrimation increased0033 (15%)33 (7.5%)
 Visual impairment11 (5%)11 (5%)22 (5%)
 Asthenopia11 (5%)0011 (2.5%)
 Erythema of eyelid0011 (5%)11 (2.5%)
 Eye discharge11 (5%)0011 (2.5%)
 Eye disorder0011 (5%)11 (2.5%)
 Eyelid pain11 (5%)0011 (2.5%)
 Eyelid sensory disorder0011 (5%)11 (2.5%)
 Ocular discomfort0011 (5%)11 (2.5%)
 Ocular hyperaemia0011 (5%)11 (2.5%)
 Vitreous detachment11 (5%)0011 (2.5%)
Infections and infestations22 (10%)55 (25%)77 (17.5%)
 Rhinitis0022 (10%)22 (5%)
 Conjunctivitis bacterial0011 (5%)11 (2.5%)
 Herpes simplex11 (5%)0011 (2.5%)
 Nasopharyngitis11 (5%)0011 (2.5%)
 Sinusitis0011 (5%)11 (2.5%)
 Urinary tract infection0011 (5%)11 (2.5%)
Nervous system disorders11 (5%)95 (25%)106 (15%)
 Headache0095 (25%)95 (12.5%)
 Migraine11 (5%)0011 (2.5%)
Musculoskeletal and connective tissue disorders0022 (10%)22 (5%)
 Back pain0011 (5%)11 (2.5%)
 Neck pain0011 (5%)11 (2.5%)
Ear and labyrinth disorders11 (5%)0011 (2.5%)
 Tinnitus11 (5%)0011 (2.5%)
Gastrointestinal disorders0011 (5%)11 (2.5%)
 Flatulence0011 (5%)11 (2.5%)
Injury, poisoning and procedural complications0011 (5%)11 (2.5%)
 Concussion0011 (5%)11 (2.5%)
 Fall0011 (5%)11 (2.5%)
  • AE, adverse events; MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SOC, system organ class; TEAEs, treatment-emerged adverse events.