Table 2.

Most common AOEs: PACE trial (N = 449 patients)

Event, no. (%)Preadjudication*Adjudicated
Angina pectoris 28 (6%) 
Peripheral arterial occlusive disease 22 (5%) 19 (4%) 
Intermittent claudication 11 (2%) 
Myocardial infarction 18 (4%) 10 (2%) 
Coronary artery disease 14 (3%) 7 (2%) 
Peripheral arterial stenosis 10 (2%) 8 (2%) 
Cerebrovascular 8 (2%) 7 (2%) 
Carotid artery stenosis 7 (2%) 7 (2%) 
Peripheral arterial occlusion 7 (2%) 7 (2%) 
Event, no. (%)Preadjudication*Adjudicated
Angina pectoris 28 (6%) 
Peripheral arterial occlusive disease 22 (5%) 19 (4%) 
Intermittent claudication 11 (2%) 
Myocardial infarction 18 (4%) 10 (2%) 
Coronary artery disease 14 (3%) 7 (2%) 
Peripheral arterial stenosis 10 (2%) 8 (2%) 
Cerebrovascular 8 (2%) 7 (2%) 
Carotid artery stenosis 7 (2%) 7 (2%) 
Peripheral arterial occlusion 7 (2%) 7 (2%) 
*

Categorization of AOEs based on Medical Dictionary for Regulatory Activities (MedDRA) preferred terms related to vascular ischemia or thrombosis used by the FDA.

Categorization of AOEs based on cardiovascular endpoints used in clinical trials used by the Independent Adjudication Committee.

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