Table 5 Rates of non-adjudicated and adjudicated AOEs by type in the total population (n = 449)
AOE | Non-adjudicated eventsa | Adjudicated eventsb | ||
|---|---|---|---|---|
Any | Serious | Any | Serious | |
Any, | 111 (25) | 90 (20) | 78 (17) | 74 (16) |
Cardiovascularc | 59 (13) | 44 (10) | 38 (8) | 37 (8) |
Cardiovascular AOEs in ≥ 1% of patients | ||||
Angina pectoris | 28 (6) | 15 (3) | 0 | 0 |
Acute MId | 18 (4) | 18 (4) | 8 (2) | 8 (2) |
MI | d | d | 10 (2) | 10 (2) |
Coronary artery disease | 14 (3) | 12 (3) | 7 (2) | 7 (2) |
Acute coronary syndrome | 7 (2) | 7 (2) | 7 (2) | 7 (2) |
Coronary artery occlusion | 5 (1) | 4 (1) | 0 | 0 |
Cerebrovascular | 41 (9) | 33 (7) | 28 (6) | 25 (6) |
Cerebrovascular AOEs in ≥ 1% of patients | ||||
Cerebrovascular accident | 11 (2) | 11 (2) | 7 (2) | 7 (2) |
Cerebral infarction | 8 (2) | 8 (2) | 8 (2) | 8 (2) |
Carotid artery stenosis | 7 (2) | 6 (1) | 7 (2) | 5 (1) |
Transient ischemic attack | 6 (1) | 4 (1) | 0 | 0 |
Peripheral vascular | 48 (11) | 38 (8) | 42 (9) | 34 (8) |
Peripheral vascular AOEs in ≥ 1% of patients | ||||
Peripheral arterial occlusive disease | 22 (5) | 17 (4) | 19 (4) | 16 (4) |
Intermittent claudication | 11 (2) | 1 (< 1) | 0 | 0 |
Peripheral artery stenosis | 10 (2) | 8 (2) | 8 (2) | 7 (2) |
Peripheral artery occlusion | 7 (2) | 5 (1) | 7 (2) | 5 (1) |
Peripheral ischemia | 7 (2) | 4 (1) | 5 (1) | 0 |
Peripheral vascular disorder | 5 (1) | 4 (1) | 0 | 0 |
Exposure-adjusted newly occurring AOEs, patients with events per 100 patient-years | 13.8 | 10.6 | 8.9 | 8.4 |