Table 1 Treatment-emergent adverse events (AEs; ≥ 10% of patients), regardless of relationship to study drug.

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

Category, n (%)a

All patients N = 115

All grades

Grade ≥ 3

Number of patients with ≥ 1 event

115 (100)

88 (76.5)

 Arthralgia

47 (40.9)

3 (2.6)

 Lipase increasedb

45 (39.1)

25 (21.7)

 Fatigue

44 (38.3)

2 (1.7)

 Headache

44 (38.3)

3 (2.6)

 Diarrhea

38 (33.0)

0

 Vomiting

37 (32.2)

3 (2.6)

 Nausea

36 (31.3)

2 (1.7)

 Hypertension

35 (30.4)

21 (18.3)

 Abdominal pain

32 (27.8)

1 (0.9)

 Dizziness

31 (27.0)

0

 Upper respiratory tract infection

31 (27.0)

1 (0.9)

 COVID-19

29 (25.2)

3 (2.6)

 Rash

29 (25.2)

0

 Pruritus

27 (23.5)

1 (0.9)

 Cough

26 (22.6)

0

 Thrombocytopenia

26 (22.6)

12 (10.4)

 Amylase increased

25 (21.7)

5 (4.3)

 Myalgia

25 (21.7)

3 (2.6)

 Constipation

24 (20.9)

1 (0.9)

 Back pain

23 (20.0)

3 (2.6)

 Pain in extremity

23 (20.0)

1 (0.9)

 Upper abdominal pain

21 (18.3)

0

 Anemia

19 (16.5)

10 (8.7)

 Peripheral edema

19 (16.5)

0

 Dyspnea

18 (15.7)

1 (0.9)

 Increased ALT

17 (14.8)

3 (2.6)

 Bone pain

17 (14.8)

2 (1.7)

 Nasopharyngitis

17 (14.8)

0

 Pyrexia

17 (14.8)

1 (0.9)

 Increased weight

17 (14.8)

3 (2.6)

 Neutropenia

16 (13.9)

10 (8.7)

 Hyperhidrosis

15 (13.0)

0

 Non-cardiac chest pain

15 (13.0)

0

 Pleural effusion

15 (13.0)

4 (3.5)

 Anxiety

14 (12.2)

1 (0.9)

 Increased AST

14 (12.2)

0

 Decreased appetite

14 (12.2)

0

 Depression

14 (12.2)

0

 Hypertriglyceridemia

14 (12.2)

3 (2.6)

 Oropharyngeal pain

14 (12.2)

0

 Increased blood creatinine

13 (11.3)

0

 Hyperglycemia

13 (11.3)

2 (1.7)

 Hyperuricemia

13 (11.3)

5 (4.3)

 Insomnia

13 (11.3)

1 (0.9)

 Dry eye

12 (10.4)

0

 Fall

12 (10.4)

2 (1.7)

 Increased γ-glutamyltransferase

12 (10.4)

3 (2.6)

 Hypophosphatemia

12 (10.4)

3 (2.6)

 Muscle spasms

12 (10.4)

0

 Pneumonia

12 (10.4)

5 (4.3)

  1. ALT alanine aminotransferase, AST aspartate aminotransferase.
  2. aA patient with multiple grades of severity for an event was only counted under the maximum grade.
  3. bDoes not include the preferred term hyperlipasemia.