Table 3 Safety profile and adverse events related to the treatment in the safety population

From: Envonalkib versus crizotinib for treatment-naive ALK-positive non-small cell lung cancer: a randomized, multicenter, open-label, phase III trial

TEAE

Envonalkib (N = 131)

Crizotinib (N = 133)

Any grade

Grade ≥3

Any grade

Grade ≥3

All TEAEs

130 (99.24)

83 (63.36)

133 (100.00)

73 (54.89)

SAEs

49 (37.40)

 

38 (28.57)

 

TRAEs

130 (99.24)

73 (55.73)

131 (98.50)

57 (42.86)

SAEs related to the study drug

33 (25.19)

 

11 (8.27)

 

TRAEs leading to dose reduction

44 (33.59)

38 (29.01)

27 (20.30)

18 (13.53)

TRAEs leading to treatment suspension

3 (2.29)

2 (1.53)

2 (1.50)

1 (0.75)

TRAEs leading to treatment discontinuation

8 (6.11)

5 (3.82)

5 (3.76)

1 (0.75)

TRAEs leading to death

0

0

1 (0.75)

1 (0.75)

TRAEs of special interest

14 (10.69)

4 (3.05)

5 (3.76)

0

The most common TEAEs (>10% in both groups)

 Diarrhea

119 (90.84)

12 (9.16)

82 (61.65)

0

 Vomiting

110 (83.97)

9 (6.87)

63 (47.37)

1 (0.75)

 Elevated ALT

98 (74.81)

20 (15.27)

91 (68.42)

9 (6.77)

 Nausea

92 (70.23)

4 (3.05)

58 (43.61)

0

 Elevated AST

91 (69.47)

13 (9.92)

82 (61.65)

3 (2.26)

 Loss of appetite

76 (58.02)

0

48 (36.09)

1 (0.75)

 Sinus bradycardia

69 (52.67)

0

54 (40.60)

1 (0.75)

 Hypoalbuminemia

63 (48.09)

2 (1.53)

50 (37.59)

1 (0.75)

 ECG QT prolongation

42 (32.06)

19 (14.50)

21 (15.79)

8 (6.02)

 Anemia

42 (32.06)

4 (3.05)

32 (24.06)

1 (0.75)

 Elevated serum creatinine

41 (31.30)

0

27 (20.30)

0

 Fatigue

41 (31.30)

2 (1.53)

32 (24.06)

1 (0.75)

 Weight loss

41 (31.30)

2 (1.53)

13 (9.77)

0

 Elevated serum CK-MB

38 (29.01)

7 (5.34)

34 (25.56)

4 (3.01)

 Elevated serum CK

38 (29.01)

4 (3.05)

49 (36.84)

5 (3.76)

 Elevated γ-GGT

36 (27.48)

12 (9.16)

27 (20.30)

2 (1.50)

 Cough

33 (25.19)

0

28 (21.05)

0

 Decreased PLT

34 (25.95)

4 (3.05)

4 (3.01)

0

 Hypokalemia

32 (24.43)

9 (6.87)

6 (4.51)

0

 Elevated serum LDH

31 (23.66)

0

45 (33.83)

0

 Decreased WBC

31 (23.66)

4 (3.05)

57 (42.86)

10 (7.52)

 Constipate

28 (21.37)

0

42 (31.58)

0

 Proteinuria

25 (19.08)

0

18 (13.53)

0

 Decreased neutrophil count

25 (19.08)

3 (2.29)

59 (44.36)

24 (18.05)

 Hyperuricemia

24 (18.32)

0

15 (11.28)

0

 Hypocalcemia

23 (17.56)

1 (0.76)

19 (14.29)

1 (0.75)

 Weight gain

21 (16.03)

3 (2.29)

31 (23.31)

3 (2.26)

 Dizziness

20 (15.27)

1 (0.76)

23 (17.29)

1 (0.75)

 Upper respiratory infection

18 (13.74)

1 (0.76)

21 (15.79)

2 (1.50)

 Peripheral edema

17 (12.98)

0

36 (27.07)

1 (0.75)

 Insomnia

17 (12.98)

0

16 (12.03)

0

 Elevated α-hydroxybutyrate dehydrogenase

14 (10.69)

0

18 (13.53)

0

 Decreased lymphocyte count

14 (10.69)

5 (3.82)

16 (12.03)

1 (0.75)

 Back pain

14 (10.69)

0

14 (10.53)

1 (0.75)

  1. TEAE treatment emergent adverse event, SAE serious adverse event, TRAE treatment-related adverse event, ALT alanine transaminase, AST aspartate aminotransferase, ECG electrocardiogram, CK-MB creatine kinase-MB, GGT serum gamma-glutamyl transferase, LDH lactate dehydrogenase, PLT platelet count, WBC white blood cell count
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