Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial
Table 3
Most frequently reported adverse events (MedDRA PTs), by time point of occurrence.
All events MedDRA PT
Month of start of event
0–3
4–6
7–9
10–12
13–15
16–18
19–21
22 and later
586 (100%)
481 (100%)
329 (100%)
289 (100%)
261 (100%)
217 (100%)
178 (100%)
243 (100%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
Visual acuity reduced
15.5
6.2
8.5
5.5
5.7
2.8
4.5
1.6
Intraocular pressure increased
11.3
7.9
4.9
5.9
6.1
7.4
6.7
7.4
Drug ineffective
4.1
6.4
4.3
4.8
6.5
3.2
1.7
2.5
Cataract operation
2.2
4.6
4.6
1.4
2.3
1.4
3.4
2.5
Ocular hypertension
2.2
1.0
1.5
1.7
0.0
0.0
0.0
0.0
Retinal haemorrhage
0.7
1.9
2.7
2.1
2.3
1.4
1.7
1.2
Adverse event
0.7
2.5
2.1
1.7
0.0
0.0
0.0
0.0
Cataract
0.3
1.2
2.4
2.4
2.3
1.8
1.1
1.2
Fall
1.4
1.7
0.9
1.4
0.8
4.1
2.8
2.1
Posterior capsule opacification
0.9
1.0
1.2
2.8
3.4
1.4
1.1
2.1
Death
1.0
0.6
1.2
2.8
1.5
3.2
1.1
3.3
Macular oedema
0.9
1.7
1.5
1.0
1.1
1.4
1.1
0.4
Vitreous haemorrhage
1.4
1.2
1.2
1.0
2.3
0.9
1.1
2.1
Eye irritation
2.6
0.6
0.3
0.0
0.0
0.0
0.0
0.0
Nasopharyngitis
0.9
0.8
2.1
0.7
0.0
0.0
0.0
0.0
Pneumonia
0.7
1.2
0.6
2.1
1.1
1.4
1.7
0.0
Cerebrovascular accident
1.5
0.2
0.9
0.3
0.8
3.2
1.1
1.6
Cardiac failure
0.2
1.0
0.3
0.7
0.8
1.4
3.4
1.2
Conjunctivitis
1.0
0.6
1.2
0.7
1.1
0.9
2.8
1.6
General physical health deterioration
0.3
0.6
0.3
1.4
1.1
0.0
0.6
2.9
Glaucoma
0.3
0.4
0.9
1.0
0.8
0.5
0.6
2.1
Hospitalization
0.0
0.2
0.6
0.3
0.0
1.4
0.6
2.1
Macular scar
0.0
0.0
0.0
0.0
0.8
0.5
1.7
1.2
Adverse event not further classified. Table shows events with an incidence rate of ≥1% per year in total. Percentages were calculated based on the total number of events in respective time period. MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term.
