2. Adverse events in GENEVA.
| Total number of adverse events inGENEVA | Comparison of dexamethasone with sham | ||||
| 0.35 mg dexamethasone | 0.70 mg dexamethasone | sham injection | 0.35 mg vs sham group (RR, CI) | 0.70 mg vs sham group (RR, CI) | |
| Elevated IOP: | |||||
| ≥ 10 mm Hg | NR | NR | NR | ‐ | ‐ |
| ≥ 35 mm Hg | NR | NR | NR | ‐ | ‐ |
| Ocular hypertension: | 16/414 (3.9%) | 17/427 (4.0%) | 3/426 (0.7%) | 5.49 (1.61, 18.69) | 5.65 (1.67, 19.15) |
| Eye pain: | 17/414 (4.1%) | 31/427 (7.3%) | 16/426 (3.8%) | 5.49 (1.61, 18.69) | 5.65 (1.67, 19.15) |
| Conjunctiva: | |||||
| Hemmorhage | 72/414 (17.4%) | 85/427 (19.9%) | 63/426 (14.8%) | 1.18 (0.86, 1.60) | 1.35 (1.00, 1.81) |
| Hyperemia | 27/414 (6.5%) | 28/427 (6.6%) | 20/426 (4.7%) | 1.39 (0.79, 2.44) | 1.40 (0.80, 2.44) |
| Cornea/lens: | |||||
| Infection/endophthalmitis | NR | NR | NR | ‐ | ‐ |
| Cataract/lens opacity | 17/414 (4.1%) | 31/427 (7.3%) | 19/426 (4.5%) | 0.92 (0.49, 1.75) | 1.63 (0.93, 2.84) |
| Iris neovascularization: | NR | NR | NR | ‐ | ‐ |
| Vitrious: | |||||
| Hemorrhage | NR | NR | NR | ‐ | ‐ |
| Detachment | 12/414 (2.9%) | 12/427 (2.8%) | 8/426 (1.9%) | 1.54 (0.64, 3.74) | 1.50 (0.62, 3.62) |
| Retina: | |||||
| Neovascularization | 4/414 (1.0%) | 3/427 (0.7%) | 11/426 (2.6%) | 0.37 (0.12, 1.17) | 0.27 (0.08, 0.97) |
| Detachment | NR | NR | NR | ‐ | ‐ |
| Hemorrhage | 8/414 (1.9%) | 12/427 (2.8%) | 10/426 (2.3%) | 0.82 (0.33, 2.07) | 1.20 (0.52, 2.74) |
| Maculopathy | 22/414 (5.3%) | 19/427 (4.4%) | 23/426 (5.4%) | 0.98 (0.56, 1.74) | 0.82 (0.46, 1.49) |
| Required additional therapy: | |||||
| IOP lowering medications | NR | NR | NR | ‐ | ‐ |
| Cataract surgery | NR | NR | NR | ‐ | ‐ |
| Photocoagulation | NR | NR | NR | ‐ | ‐ |
| Pars plana vitrectomy | NR | NR | NR | ‐ | ‐ |
CI: 95% confidence interval IOP: intraocular pressure mg: milligram mm Hg: millimeter of mercury NR: not reported RR: risk ratio