Table 3.
Incidence and severity of prespecified ocular adverse events in the study eye, all causality
| |
Pegaptanib 0.3 mg |
|||||
|---|---|---|---|---|---|---|
|
Subjects |
With Diabetes |
Without Diabetes |
||||
| (N = 165 ) | (N = 1,421) | |||||
|
Preferred Term1 |
n |
(%) |
Severe |
n |
(%) |
Severe |
| Cataract, traumatic |
0 |
0 |
0 |
1 |
(0.1) |
0 |
| Detachment of retinal pigment epithelium |
0 |
0 |
0 |
3 |
(0.2) |
0 |
| Endophthalmitis |
1 |
(0.6) |
1 |
16 |
(1.1) |
14 |
| Eye hemorrhage |
0 |
0 |
0 |
6 |
(0.4) |
2 |
| Eye hemorrhage NOS |
0 |
0 |
0 |
3 |
(0.2) |
0 |
| Glaucoma |
0 |
0 |
0 |
2 |
(0.1) |
0 |
| Glaucoma NOS |
0 |
0 |
0 |
2 |
(0.1) |
0 |
| Intraocular pressure increased |
13 |
(7.9) |
0 |
155 |
(10.9) |
6 |
| Ocular hypertension |
0 |
0 |
0 |
11 |
(0.8) |
0 |
| Retinal detachment |
1 |
(0.6) |
0 |
9 |
(0.6) |
5 |
| Retinal hemorrhage |
8 |
(4.8) |
1 |
64 |
(4.5) |
6 |
| Retinal pigment epitheliopathy |
4 |
(2.4) |
0 |
10 |
(0.7) |
0 |
| Retinal tear |
1 |
(0.6) |
0 |
0 |
(0.4) |
0 |
| Vitreous hemorrhage | 3 | (1.8) | 0 | 21 | (1.5) | 2 |
1Preferred terms are from MedDRA [Medical Dictionary for Regulatory Activities, version 12.1].
NOS: not otherwise specified.