|
AOE
|
Non-adjudicated eventsa
|
Adjudicated eventsb
|
|---|
|
Any
|
Serious
|
Any
|
Serious
|
|---|
|
Any,
|
84 (31)
|
69 (26)
|
57 (21)
|
54 (20)
|
|
Cardiovascularc
|
42 (16)
|
33 (12)
|
26 (10)
|
25 (9)
|
|
Cerebrovascular
|
35 (13)
|
28 (10)
|
25 (9)
|
22 (8)
|
|
Peripheral vascular
|
38 (14)
|
31 (11)
|
31 (11)
|
26 (10)
|
|
Exposure-adjusted newly occurring AOEs, patients with events per 100 patient-years
|
11.3
|
9.3
|
8.7
|
8.1
|
- 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
