Table 5.
|
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.