Cumulative and exposure-adjusted incidences of treatment-emergent AOEs and VTEs
| . | CP-CML, n = 270 . | Total, N = 449 . | ||
|---|---|---|---|---|
| AE . | SAE . | AE . | SAE . | |
| AOEs, n (%) | 84 (31)* | 69 (26)† | 111 (25)‡ | 90 (20)§ |
| Cardiovascular | 42 (16) | 33 (12) | 59 (13) | 44 (10) |
| Cerebrovascular | 35 (13) | 28 (10) | 41 (9) | 33 (7) |
| Peripheral vascular | 38 (14) | 31 (11) | 48 (11) | 38 (8) |
| Exposure-adjusted AOEs, no. of patients with events per 100 patient-years | 14.1 | 10.9 | 13.8 | 10.6 |
| VTEs, n (%) | 15 (6) | 13 (5) | 27 (6) | 23 (5) |
| Exposure-adjusted VTEs, no. of patients with events per 100 patient-years | 2.1 | 1.8 | 2.8 | 2.4 |
| . | CP-CML, n = 270 . | Total, N = 449 . | ||
|---|---|---|---|---|
| AE . | SAE . | AE . | SAE . | |
| AOEs, n (%) | 84 (31)* | 69 (26)† | 111 (25)‡ | 90 (20)§ |
| Cardiovascular | 42 (16) | 33 (12) | 59 (13) | 44 (10) |
| Cerebrovascular | 35 (13) | 28 (10) | 41 (9) | 33 (7) |
| Peripheral vascular | 38 (14) | 31 (11) | 48 (11) | 38 (8) |
| Exposure-adjusted AOEs, no. of patients with events per 100 patient-years | 14.1 | 10.9 | 13.8 | 10.6 |
| VTEs, n (%) | 15 (6) | 13 (5) | 27 (6) | 23 (5) |
| Exposure-adjusted VTEs, no. of patients with events per 100 patient-years | 2.1 | 1.8 | 2.8 | 2.4 |
Categorization of AOEs and VTEs is based on a broad collection of >400 MedDRA preferred terms related to vascular ischemia or thrombosis.
AE, total adverse event (including SAEs); AOE, arterial occlusive event; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event only (designated as serious by the investigator, in accordance with standard regulatory criteria); VTE, venous thromboembolic event. Other abbreviations are explained in Table 1.
Forty-six patients had >1 AOE.
Thirty-one patients had >1 serious AOE.
Fifty-seven patients had >1 AOE.
Thirty-eight patients had >1 serious AOE.