Table 2 Exposure-adjusted incidence rates (EAIR) of all-grade adverse events of special interest.

From: Asciminib monotherapy in patients with chronic myeloid leukemia in chronic phase without BCR::ABL1T315I treated with at least 2 prior TKIs: Phase 1 final results

EAIR, n (per 100 patient treatment years)

All patients N = 115

Gastrointestinal events

85 (51.0)

Hypersensitivity

56 (17.1)

Pancreatic events (including isolated pancreatic enzyme elevations)

54 (15.7)

 Pancreatitis (clinical events)a

8 (1.4)

Myelosuppressionb

42 (9.4)

 Thrombocytopenia

30 (6.1)

 Anemia

21 (4.1)

 Leukopenia

21 (4.1)

  Neutropenia

19 (3.6)

 Cytopenias affecting > 1 lineage

1 (0.2)

Hepatotoxicity (including laboratory terms)

36 (7.9)

 Hepatotoxicity (clinical events)

5 (0.9)

Edema and fluid retention

35 (7.6)

Hemorrhage

27 (5.5)

Ischemic heart and CNS conditions

18 (3.5)

 Ischemic heart disease

15 (2.8)

 Ischemic CNS vascular conditions

5 (0.9)

Arterial occlusive events

14 (2.6)

Phototoxicity

11 (2.0)

Cardiac failure (clinical events)

9 (1.6)

QTc prolongation

9 (1.6)

  1. CNS central nervous system, QTc corrected QT interval.
  2. aIncludes preferred terms pancreatitis and acute pancreatitis.
  3. bMyelosuppression included erythropenia, leukopenia, thrombocytopenia, and cytopenias affecting more than one lineage.
Back to article page