Table 7.
Arterial occlusive events (AOEs) in ≥ 2.0% of patients (n = 449)
| AOE | Any AOE | Serious AOE | ||
|---|---|---|---|---|
| Non-adjudicateda | Adjudicatedb | Non-adjudicateda | Adjudicatedb | |
| Angina pectoris | 28 (6) | 0 | 15 (3) | 0 |
| Peripheral arterial occlusive disease | 22 (5) | 19 (4) | 17 (4) | 16 (4) |
| Myocardial infarction | 18 (4) | 10 (2) | 18 (4) | 10 (2) |
| Coronary artery disease | 14 (3) | 7 (2) | 12 (3) | 7 (2) |
| Cerebrovascular accident | 11 (2) | 7 (2) | 11 (2) | 7 (2) |
| Intermittent claudication | 11 (2) | 0 | 1 (< 1) | 0 |
| Peripheral artery stenosis | 10 (2) | 8 (2) | 8 (2) | 7 (2) |
| Cerebral infarction | 8 (2) | 8 (2) | 8 (2) | 8 (2) |
| Acute coronary syndrome | 7 (2) | 7 (2) | 7 (2) | 7 (2) |
| Carotid artery stenosis | 7 (2) | 7 (2) | 6 (1) | 5 (1) |
| Peripheral artery occlusion | 7 (2) | 7 (2) | 5 (1) | 5 (1) |
| Peripheral ischemia | 7 (2) | 5 (1) | 4 (1) | 0 |
Data are no. (%) of patients
MedDRA Medical Dictionary for Regulatory Activities
aCategorization of AOEs is based on MedDRA preferred terms related to vascular ischemia or thrombosis
bEvents adjudicated as AOEs by the cardiovascular endpoint Adjudication Committee