Table 2.
Cumulative and exposure-adjusted incidences of treatment-emergent AOEs and VTEs (adapted from [6])
| CP-CML (n = 270) |
Total (n = 449) |
|||
|---|---|---|---|---|
| AE | SAE | AE | SAE | |
| AOEs, n (%) | 84 (31)a | 69 (26)b | 111 (25)c | 90 (20)d |
| CV, n (%) | 42 (16) | 33 (12) | 59 (13) | 44 (10) |
| Cerebrovascular, n (%) | 35 (13) | 28 (10) | 41 (9) | 33 (7) |
| Peripheral vascular, n (%) | 38 (14) | 31 (11) | 48 (11) | 38 (8) |
| Exposure-adjusted AOEs, number of patients with events per 100 patient-years | 14.1 | 10.9 | 13.8 | 19.6 |
| VTEs, n (%) | 15 (6) | 13 (5) | 27 (6) | 23 (5) |
| Exposure-adjusted VTEs, number of patients with events per 100 patient-years | 2.1 | 1.8 | 2.8 | 2.4 |
a
46 patients had >1 AOE
b
31 patients had >1 serious AOE
c
57 patients had >1 AOE
d
38 patients had >1 serious AOE. Categorization of AOEs and VTEs is based on a broad collection of >400 MedDRA preferred terms related to vascular ischemia or thrombosis; AE, adverse event; AOE, arterial occlusive event; MedDRA, medical dictionary for regulatory activities; SAE, serious adverse event only; VTE, venous thromboembolic event; CV, cardiovascular; CP-CML, chronic phase-chronic myeloid leukemia.