A retrospective, pooled data analysis of the safety of pegaptanib sodium in the treatment of age-related macular degeneration in subjects with or without diabetes mellitus

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 Term ¹	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.

ISSN: 1471-2415