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

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

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