Table 3.
Ocular and non-ocular AEsa (safety set)
| Preferred term, n (%) | Ranibizumab 0.5 mg VA only (Group I) N = 334 |
Ranibizumab 0.5 mg VA and/or OCT (Group II) N = 336 |
|---|---|---|
| Ocular, Total | 105 (31.4) | 106 (31.5) |
| - Conjunctival hemorrhage | 19 (5.7) | 10 (3.0) |
| - IOP increased | 12 (3.6) | 21 (6.3) |
| - Eye pain | 10 (3.0) | 9 (2.7) |
| - Dry eye | 10 (3.0) | 7 (2.1) |
| - VA reduced | 7 (2.1) | 1 (0.3) |
| - Vitreous floaters | 6 (1.8) | 8 (2.4) |
| Non-ocular, Total | 156 (46.7) | 143 (42.6) |
| - Nasopharyngitis | 24 (7.2) | 11 (3.3) |
| - Hypertension | 18 (5.4) | 16 (4.8) |
| - Influenza | 15 (4.5) | 15 (4.5) |
| - Cough | 7 (2.1) | 7 (2.1) |
| - Bronchitis | 7 (2.1) | 6 (1.8) |
| - Osteoarthritis | 7 (2.1) | 6 (1.8) |
| - Arthralgia | 7 (2.1) | 5 (1.5) |
| - Back pain | 4 (1.2) | 10 (3.0) |
| - Urinary tract infection | 2 (0.6) | 7 (2.1) |
The safety set consisted of all patients who received at least one application of study drug and had at least one post-baseline safety assessment
MedDRA Version 18.1 was used for the reporting of AEs
A patient with multiple occurrences of an AE under one treatment was counted only once in the AEs category
Preferred terms are sorted by descending order of incidence in Group I column
AE adverse event, IOP intraocular pressure, MedDRA Medical Dictionary for Regulatory Activities, OCT optical coherence tomography, VA visual acuity
aReported in ≥2% of patients in any group. Treatment exposure: The mean (SD) number of injections for the overall population (safety set) was 7.3 (2.67) and 7.6 (2.98) in Groups I and II, respectively; the median number of injections was 7.0 in both groups