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Table 5 Incidence and severity of prespecified antiplatelet trialists’ collaboration events, all causality 1

From: 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

 

Pegaptanib sodium 0.3 mg

Sham

Number of Subjects

With Diabetes

Without Diabetes

With Diabetes

 

(N = 165)

(N = 1421)

(N = 26)

Preferred Term 2

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

  1. 1In cases in which subjects experienced the same event more than once, the worst severity was presented.
  2. 2Adverse event with a start date between the day of the first injection and at most 42 days after the last injection.
  3. Preferred terms are from MedDRA [Medical Dictionary for Regulatory Activities, version 12.1].
  4. LT: life-threatening.
  5. NOS: not otherwise specified.
  6. Sev: severe.