Ocular drug-related AEs (by Preferred Term) and ocular AEs of special interest during the study (by Safety Risk and Preferred Term; Treated eyes of safety set patients*)
| Preferred term, n (%) | Total (N=1049) |
| Eyes with at least one ocular drug-related AE | 9 (0.9) |
| Conjunctival haemorrhage | 3 (0.3) |
| Foreign body sensation in eyes | 1 (0.1) |
| Ocular discomfort | 1 (0.1) |
| Ocular hypertension | 3 (0.3) |
| Retinal degeneration | 1 (0.1) |
| Retinal haemorrhage† | 1 (0.1) |
| Eyes with at least one ocular AEs of special interest | 11 (1.1) |
| Intraocular inflammation | 4 (0.4) |
| Macular oedema | 1 (0.1) |
| Ocular hyperaemia | 1 (0.1) |
| Retinal oedema | 2 (0.2) |
| Intraocular pressure | 6 (0.6) |
| Ocular hypertension | 6 (0.6) |
| Retinal detachment and retinal tear | 1 (0.1) |
| Retinal tear‡ | 1 (0.1) |
The table summarises ocular AEs that occurred during the study and reported independently from the definition of the risk period. Total number of eyes refers to both eyes of the safety set patients, since AEs were recorded and counted even if occurred on the eye not treated with the study drug. AEs with Site='Both eyes' were counted twice in the present analysis (ie, once for each eye). Each eye could experience more than one AE. Eyes were counted only once in each row. Terms were coded using MedDRA dictionary, version 18.1.
*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.
†Identified as serious AE.
‡Search was performed with and without LLT serous detachment of macula.
AE, adverse event;LLT, Lower-level term; MedDRA, Medical Dictionary for Drug Regulatory Activities.