Table 3 Arterial occlusive eventsa.

From: Asciminib in combination with imatinib, nilotinib, or dasatinib in patients with chronic myeloid leukemia in chronic or accelerated phase: phase 1 study final results

Variable, n (%)

ASC + NIL

(n = 26)

ASC + IMA

(n = 25)

ASC + DAS

(n = 32)

All grade

Grade ≥ 3

All grade

Grade ≥ 3

All grade

Grade ≥ 3

AOEs, total no. of patientsb

3 (11.5)

1 (3.8)

1 (4.0)

0 (0)

1 (3.1)

0 (0)

Cardiac events

2 (7.7)

1 (3.8)c

0 (0)

0 (0)

0 (0)

0 (0)

  Angina pectoris

2 (7.7)c

1 (3.8)c

0 (0)

0 (0)

0 (0)

0 (0)

Cerebrovascular events

2 (7.7)

0 (0)

0 (0)

0 (0)

1 (3.1)

0 (0)

  Cerebral arteriosclerosis

1 (3.8)c

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

  Cerebrovascular accident

1 (3.8)c

0 (0)

0 (0)

0 (0)

1 (3.1)

0 (0)

Peripheral arterial occlusive disease

2 (7.7)

1 (3.8)c

1 (4.0)

0 (0)

0 (0)

0 (0)

  Peripheral arterial occlusive disease

2 (7.7)c

1 (3.8)c

0 (0)

0 (0)

0 (0)

0 (0)

  Embolism arterial

0 (0)

0 (0)

1 (4.0)

0 (0)

0 (0)

0 (0)

Exposure-adjusted AOE rate, n (incidence rate per 100 patient treatment-years)

3 (4.5)

1 (1.2)

1 (1.0)

Cardiac failure (clinical events)

1 (3.8)d

0 (0)

2 (8.0)e

0 (0)

1 (3.1)f

0 (0)

  1. AE adverse event, AOE arterial occlusive event, ASC asciminib, BID twice daily, DAS dasatinib, IMA imatinib, NIL nilotinib, QD once daily.
  2. aA patient with multiple severity grades for an AE is only counted under the maximum grade. bAOEs include the following Medical Dictionary for Regulatory Activities terms: myocardial infarction; embolic and thrombotic events, arterial; ischemic central nervous system vascular conditions; ischemic heart disease. cOne patient in the ASC + NIL arm experienced angina pectoris, cerebral arteriosclerosis, cerebrovascular accident, and peripheral arterial occlusive disease. dOne patient in the ASC 20 mg BID plus NIL 300 mg BID cohort experienced cardiac failure. eOne patient each in the ASC 40 mg BID plus IMA 400 mg QD and ASC 60 mg QD plus IMA 400 mg QD cohorts experienced cardiac failure. fOne patient in the ASC 40 mg BID plus DAS 100 mg QD cohort experienced 2 pulmonary edema events.