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Table 3 Treatment-related adverse events (≥ 10%, all grade)

From: Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label, multicenter phase 1/2 trial

 

Total

Chronic phase CML

Accelerated phase CML

Patient number

165

127

38

Event, n (%)

Any grades

G 3/4

Any grades

G 3/4

Any grades

G 3/4

Treatment-related adverse events

165 (100.0)

131 (79.4)

127 (100.0)

97 (76.4)

38 (100.0)

34 (89.5)

Nonhematologic

165 (100.0)

81 (49.1)

127 (100.0)

61 (48.0)

38 (100.0)

20 (52.6)

Skin pigmentation

139 (84.2)

0

108 (85.0)

0

31 (81.6)

0

Hypertriglyceridemia

95 (57.6)

12 (7.3)

72 (56.7)

11 (8.7)

23 (60.5)

1 (2.6)

Proteinuria

84 (50.9)

6 (3.6)

65 (51.2)

5 (3.9)

19 (50.0)

1 (2.6)

Hyperbilirubinemia

69 (41.8)

4 (2.4)

56 (44.1)

3 (2.4)

13 (34.2)

1 (2.6)

Hypocalcemia

64 (38.8)

0

45 (35.4)

0

19 (50.0)

0

Increased alanine aminotransferase

59 (35.8)

4 (2.4)

50 (39.4)

3 (2.4)

9 (23.7)

1 (2.6)

Increased aspartate aminotransferase

59 (35.8)

4 (2.4)

49 (38.6)

2 (1.6)

10 (26.3)

2 (5.3)

Increased creatine phosphokinase

48 (29.1)

11 (6.7)

43 (33.9)

10 (7.9)

5 (13.2)

1 (2.6)

Increased γ-glutamyl transferase

47 (28.5)

5 (3.0)

38 (29.9)

5 (3.9)

9 (23.7)

0

Hyperglycemia

43 (26.1)

1 (0.6)

33 (26.0)

1 (0.8)

10 (26.3)

0

Hypokalemia

42 (25.5)

2 (1.2)

32 (25.2)

1 (0.8)

10 (26.3)

1 (2.6)

Hyponatremia

38 (23.0)

1 (0.6)

28 (22.0)

1 (0.8)

10 (26.3)

0

Myalgia

31 (18.8)

0

23 (18.1)

0

8 (21.1)

0

Pyrexia

30 (18.2)

9 (5.5)

21 (16.5)

5 (3.9)

9 (23.7)

4 (10.5)

Sinus tachycardia

30 (18.2)

0

23 (18.1)

0

7 (18.4)

0

Rash

27 (16.4)

1 (0.6)

19 (15.0)

1 (0.8)

8 (21.1)

0

Hypoalbuminemia

26 (15.8)

0

20 (15.7)

0

6 (15.8)

0

Hyperphosphatemia

22 (13.3)

0

11 (8.7)

0

11 (28.9)

0

Hypertension

22 (13.3)

9 (5.5)

19 (15.0)

7 (5.5)

3 (7.9)

2 (5.3)

Increased lipase

22 (13.3)

5 (3.0)

16 (12.6)

5 (3.9)

6 (15.8)

0

Increased alkaline phosphatase

21 (12.7)

1 (0.6)

16 (12.6)

1 (0.8)

5 (13.2)

0

Pain in extremity

21 (12.7)

2 (1.2)

14 (11.0)

1 (0.8)

7 (18.4)

1 (2.6)

Arthralgia

19 (11.5)

1 (0.6)

11 (8.7)

0

8 (21.1)

1 (2.6)

Asthenia

18 (10.9)

0

12 (9.4)

0

6 (15.8)

0

Hematologic

138 (83.6)

93 (56.4)

102 (80.3)

67 (52.8)

36 (94.7)

26 (68.4)

Thrombocytopenia

126 (76.4)

85 (51.5)

93 (73.2)

62 (48.8)

33 (86.8)

23 (60.5)

Anemia

90 (54.5)

38 (23.0)

66 (52.0)

26 (20.5)

24 (63.2)

12 (31.6)

Leukopenia

56 (33.9)

34 (20.6)

37 (29.1)

21 (16.5)

19 (50.0)

13 (34.2)

Neutropenia

26 (15.8)

19 (11.5)

18 (14.2)

11 (8.7)

8 (21.1)

8 (21.1)