Table 5

Incidence and severity of prespecified antiplatelet trialists’ collaboration events, all causality1
Pegaptanib sodium 0.3 mg Sham
Number of Subjects With Diabetes Without Diabetes With Diabetes
(N = 165) (N = 1421) (N = 26)
Preferred Term2 n (%) Sev LT n (%) Sev LT n (%) Sev Lt
Acute myocardial infarction 0 0 0 0 1 (0.1) 0 0 1 (3.8) 0 1
Angina pectoris 1 (0.6) 1 0 8 (0.6) 2 1 1 (3.8) 0 0
Angina unstable 0 0 0 0 4 (0.3) 2 0 0 0 0 0
Cardiac arrest 0 0 0 0 2 (0.1) 0 2 0 0 0 0
Cardiac failure congestive 0 0 0 0 5 (0.4) 1 2 1 (3.8) 1 0
Cerebral hemorrhage 0 0 0 0 1 (0.1) 0 1 0 0 0 0
Cerebrovascular accident 3 (1.8) 3 0 9 (0.6) 5 1 0 0 0 0
Coronary artery atherosclerosis 2 (1.2) 1 0 0 0 0 0 0 0 0 0
Coronary artery disease NOS 1 (0.6) 0 0 9 (0.6) 3 0 0 0 0 0
Coronary artery occlusion 0 0 0 0 1 (0.1) 1 0 0 0 0 0
Myocardial infarction 2 (1.2) 1 0 10 (0.7) 7 2 0 0 0 0
Pulmonary embolism 1 (0.6) 1 0 7 (0.5) 4 1 0 0 0 0
Retroperitoneal hemorrhage 0 0 0 0 1 (0.1) 1 0 1 (0.1) 1 0
Thrombosis 1 (0.6) 1 0 0 0 0 0 0 0 0 0
Transient ischemic attack 1 (0.6) 0 0 8 (0.6) 2 0 0 0 0 0
Silent myocardial infarction 1 (0.6) 0 0 0 0 0 0 0 0 0 0
Ischemia NOS 0 0 0 0 1 (0.1) 0 0 0 0 0 0
Deep vein thrombosis 0 0 0 0 4 (0.3) 1 0 0 0 0 0

1In cases in which subjects experienced the same event more than once, the worst severity was presented.

2Adverse event with a start date between the day of the first injection and at most 42 days after the last injection.

Preferred terms are from MedDRA [Medical Dictionary for Regulatory Activities, version 12.1].

LT: life-threatening.

NOS: not otherwise specified.

Sev: severe.

Dombi et al.

Dombi et al. BMC Ophthalmology 2012 12:37   doi:10.1186/1471-2415-12-37

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