Table 6

Ocular adverse events (Safety set*)

Preferred term, n (%)Total
(N=1872)
Eyes with at least one ocular AE†127 (6.8)
 nAMD35 (1.9)
 Conjunctivitis14 (0.8)
 Cataract13 (0.7)
 Conjunctival haemorrhage13 (0.7)
 Ocular hypertension9 (0.5)
Eyes with at least one serious ocular AE3 (0.2)
 Ocular hypertension1 (0.1)
 Retinal haemorrhage1 (0.1)
 Vitreous haemorrhage1 (0.1)
Eyes with at least one non-serious ocular AE†125 (6.7)
 nAMD35 (1.9)
 Cataract13 (0.7)
 Conjunctival haemorrhage13 (0.7)
 Ocular hypertension9 (0.5)
 Conjunctivitis14 (0.8)
  • All systemic AEs during the study and reported, independently from the definition of the risk period. Each patient could have more than one AE. Except for the number of AEs, patients were counted only once in each row. Terms were coded using MedDRA dictionary, version 18.1.

  • *Preferred Terms≥0.5% are included in this table.

  • †Consisted of all enrolled patients who signed the informed consent, received at least one dose of study drug and had at least one postbaseline safety assessment.

  • AE, adverse event; MedDRA, Medical Dictionary for Drug Regulatory Activities.