AOEs reported in frontline randomized trials with ≥4 y follow-up
| . | DASISION9 * . | ENESTnd10 † . | BELA40 ‡ . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | Dasatinib . | Imatinib . | Nilotinib . | Imatinib . | Bosutinib . | Imatinib . | ||||||
| . | Any grade . | Grade 3–5 . | Any grade . | Grade 3–5 . | Any grade . | Grade 3–5 . | Any grade . | Grade 3–5 . | Any grade . | Grade 3–5 . | Any grade . | Grade 3–5 . |
| Any ischemic event | 4.65 | 3.49 | 2.32 | 1.55 | 7.8 | 4.6 | 2.1 | 1.8 | 4.84 | 1.21 | 3.59 | 1.59 |
| Cardiovascular | 3.88 | 2.71 | 1.55 | 1.16 | 3.9 | 2.2 | 1.8 | 1.4 | 2.42 | 0.81 | 1.99 | 0.40 |
| Cerebrovascular | 0.78 | 0.78 | 0 | 0 | 1.4 | 1.1 | 0.4 | 0.4 | 0.81 | 0.40 | 0.80 | 0.80 |
| Peripheral arterial disease | 0 | 0 | 0.77 | 0.39 | 2.5 | 1.4 | 0 | 0 | 1.61 | 0 | 0.80 | 0.40 |
| . | DASISION9 * . | ENESTnd10 † . | BELA40 ‡ . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | Dasatinib . | Imatinib . | Nilotinib . | Imatinib . | Bosutinib . | Imatinib . | ||||||
| . | Any grade . | Grade 3–5 . | Any grade . | Grade 3–5 . | Any grade . | Grade 3–5 . | Any grade . | Grade 3–5 . | Any grade . | Grade 3–5 . | Any grade . | Grade 3–5 . |
| Any ischemic event | 4.65 | 3.49 | 2.32 | 1.55 | 7.8 | 4.6 | 2.1 | 1.8 | 4.84 | 1.21 | 3.59 | 1.59 |
| Cardiovascular | 3.88 | 2.71 | 1.55 | 1.16 | 3.9 | 2.2 | 1.8 | 1.4 | 2.42 | 0.81 | 1.99 | 0.40 |
| Cerebrovascular | 0.78 | 0.78 | 0 | 0 | 1.4 | 1.1 | 0.4 | 0.4 | 0.81 | 0.40 | 0.80 | 0.80 |
| Peripheral arterial disease | 0 | 0 | 0.77 | 0.39 | 2.5 | 1.4 | 0 | 0 | 1.61 | 0 | 0.80 | 0.40 |
5-y follow-up report. Cardiovascular events include myocardial infarction, angina pectoris, coronary artery disease, and acute coronary syndrome; cerebrovascular events included only transient ischemic attack; peripheral arterial disease not specified.
Minimum 5-y follow-up. Nilotinib dosage was 300 mg twice daily. Ischemic heart disease was defined as any AE reported under any preferred term (PT) in the standardized MedDRA queries (SMQ) narrow terms for ischemic heart disease. Ischemic cerebrovascular event was defined as any AE reported under any PT in the SMQ narrow terms for ischemic cerebrovascular conditions. An SMQ for peripheral artery disease (PAD) does not currently exist; therefore, PAD events were identified by the following PTs: arterial occlusive disease, arterial stenosis, femoral artery occlusion, intermittent claudication, ischemic limb pain, peripheral arterial occlusive disease, peripheral artery angioplasty, peripheral artery bypass, peripheral artery restenosis, peripheral artery stenosis, peripheral artery stent insertion, peripheral artery thrombosis, peripheral coldness, peripheral ischemia, peripheral revascularization, peripheral vascular disorder, poor peripheral circulation, and Raynaud’s phenomenon.
Bosutinib 500 mg once daily was used in this study. Follow-up was ≥48 mo. Analysis was based on MedDRA PTs “likely indicating vascular or cardiac toxicities”; cerebrovascular treatment-emergent adverse events (TEAEs) (related high-level terms under the high-level group terms central nervous system [CNS] vascular disorders, including CNS hemorrhages and cerebrovascular accidents, CNS vascular disorders not elsewhere classified [NEC], and transient cerebrovascular events), cardiovascular TEAEs (all PTs under the high-level terms ischemic coronary artery disorders and coronary artery disorders NEC), and peripheral vascular TEAEs (related terms under the high-level group terms arteriosclerosis, stenosis, vascular insufficiency and necrosis, embolism and thrombosis, vascular disorders NEC, cardiac and vascular investigations excluding enzyme tests, and vascular therapeutic procedures).