Table 4. All-causality non-ocular adverse events in ⩾5% of subjects (year 3, safety population) (n (%)).
Adverse event (system organ class) | All subjects who received active therapy for 3 years n = 161 |
Investigations* | 41 (25) |
Infections and infestations | 29 (18) |
Respiratory, thoracic and mediastinal disorders | 24 (15) |
Gastrointestinal disorders | 23 (14) |
Musculoskeletal and connective tissue disorders | 20 (12) |
Nervous system disorders | 18 (11) |
Cardiac disorders | 17 (11) |
Injury, poisoning and procedural complications | 16 (10) |
Vascular disorders | 15 (9) |
Skin and subcutaneous tissue disorders | 14 (9) |
Metabolism and nutrition disorders | 10 (6) |
Neoplasms benign, malignant and unspecified | 9 (6) |
*The majority of these events were “increased intraocular pressure (IOP)”; the investigators were required to report an IOP of ⩾30 mm Hg at 30 min after injection as an adverse event.