Research Article
Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial
Table 2
Most commonly reported adverse events (MedDRA PT level), by category.
| | Category of patients with events (%) | nsAE | SAE | nsADR | sADR | | 451 (100.0%) | 417 (100.0%) | 498 (100.0%) | 213 (100.0%) |
| | Most frequently reported events (% of patients with events in respective category) | Intraocular pressure increased (14.4%) | Visual acuity reduced (11.8%) | Drug ineffective (20.3%) | Visual acuity reduced (18.3%) | | Cataract operation (12.6%) | Fall (5.8%) | Visual acuity reduced (16.5%) | Death (11.3%) | | Visual acuity reduced (7.5%) | Pneumonia (5.3%) | Intraocular pressure increased (13.1%) | Cerebrovascular accident (7.5%) | | Posterior capsule opacification (6.0%) | Cardiac failure (5.0%) | Adverse event (5.2%) | Intraocular pressure increased (4.2%) | | Conjunctivitis (5.5%) | Vitreous haemorrhage (4.6%) | | Retinal haemorrhage (4.2%) | | Cataract (5.3%) | Death (4.6%) | | Hospitalization (4.2%) | | | Retinal haemorrhage (4.3%) | | |
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Adverse event not further classified MedDRA, Medical Dictionary for Regulatory Activities; nsADR, nonserious adverse drug reaction; nsAE, nonserious adverse event; PT, preferred term; sADR, serious adverse drug reaction; SAE, serious adverse event. |
