Retrospective analysis of arterial occlusive events in the PACE trial by an independent adjudication committee

Table 5 Rates of non-adjudicated and adjudicated AOEs by type in the total population (n = 449)

AOE	Non-adjudicated events^a		Adjudicated events^b
AOE	Any	Serious	Any	Serious
Any,	111 (25)	90 (20)	78 (17)	74 (16)
Cardiovascular^c	59 (13)	44 (10)	38 (8)	37 (8)
Cardiovascular AOEs in ≥ 1% of patients
Angina pectoris	28 (6)	15 (3)	0	0
Acute MI^d	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

Data are no. (%) of patients, unless otherwise specified
AOE arterial occlusive event, CP-CML chronic-phase chronic myeloid leukemia, MedDRA Medical Dictionary for Regulatory Activities, MI myocardial infarction, PT preferred term
^aCategorization of AOEs is based on > 400 MedDRA preferred terms related to vascular ischemia or thrombosis
^bEvents that were adjudicated as an AOE by the adjudication committee
^cDoes not include arterial hypertension AEs
^dAcute MI and MI were grouped as a single category in the non-adjudicated analysis

ISSN: 1756-8722