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Table 4 Drug-related nonhematologic adverse events, that occurred in ≥ 10% of patients in any treatment arm, hematologic adverse events, and biochemical abnormalities, during the ENESTnd trial.

From: First-line treatment for chronic myeloid leukemia: dasatinib, nilotinib, or imatinib

 

All grade (grade 3-4), % of patients

Adverse event

Imatinib

400 mg QD

Nilotinib

300 mg BID

Nilotinib

400 mg BID

Nonhematologic

   

   Nausea

31 (0)

11 (< 1)

19 (1)

   Diarrhea

21 (1)

8 (1)

6 (0)

   Vomiting

14 (0)

5 (0)

9 (1)

   Rash

11 (1)

31 (< 1)

36 (3)

   Pruritus

5 (0)

15 (< 1)

13 (< 1)

   Alopecia

4 (0)

8 (0)

13 (0)

   Headache

8 (0)

14 (1)

21 (1)

   Fatigue

8 (< 1)

11 (0)

9 (1)

   Muscle spasm

24 (1)

7 (0)

6 (1)

   Myalgia

10 (0)

10 (< 1)

10 (0)

   Peripheral edema

14 (0)

5 (0)

5 (0)

   Eyelid edema

13 (< 1)

1 (0)

2 (< 1)

   Periorbital edema

12 (0)

< 1 (0)

1 (0)

Hematologic

   

   Neutropenia

68 (20)

43 (12)

38 (10)

   Thrombocytopenia

56 (9)

48 (10)

49 (12)

   Anemia

47 (5)

38 (3)

38 (3)

Biochemical abnormalities

   

   Elevated AST

23 (1)

40 (1)

48 (3)

   Elevated ALT

20 (2)

66 (4)

73 (9)

   Elevated bilirubin

10 (< 1)

53 (4)

62 (8)

   Elevated lipase

11 (3)

24 (6)

29 (6)

   Hyperglycemia

20 (0)

36 (6)

41 (4)

   Elevated creatinine

13 (< 1)

5 (0)

5 (0)

   Elevated amylase

12 (1)

15 (< 1)

18 (1)

   Elevated alkaline phosphatase

33 (< 1)

21 (0)

27 (0)

   Decreased phosphorus

45 (8)

32 (5)

34 (5)

  1. ALT: alanine aminotransferase; AST: aspartate aminotransferase; BID: twice daily; QD: once daily.