Table 3 TEAEs and TRAEs (safety analysis set, n = 137)

From: The type II RAF inhibitor tovorafenib in relapsed/refractory pediatric low-grade glioma: the phase 2 FIREFLY-1 trial

Preferred term, n (%)

TEAEs

TRAEs

Any grade

Grade ≥3

Any grade

Grade ≥3

Patients with any AE

137 (100)

86 (63)

134 (98)

58 (42)

Hair color changes

104 (76)

0

104 (76)

0

Anemia

81 (59)

15 (11)

67 (49)

14 (10)

Elevated CPK

80 (58)

16 (12)

77 (56)

16 (12)

Fatigue

76 (55)

6 (4)

60 (44)

6 (4)

Vomiting

68 (50)

6 (4)

28 (20)

3 (2)

Hypophosphatemia

64 (47)

0

48 (35)

0

Headache

61 (45)

2 (1)

29 (21)

0

Maculopapular rash

60 (44)

11 (8)

56 (41)

11 (8)

Pyrexia

53 (39)

5 (4)

17 (12)

1 (1)

Dry skin

49 (36)

0

45 (33)

0

Elevated LDH

48 (35)

0

42 (31)

0

Increased AST

47 (34)

4 (3)

41 (30)

4 (3)

Constipation

45 (33)

0

31 (23)

0

Nausea

45 (33)

0

25 (18)

0

Upper RTI

43 (31)

2 (1)

2 (1)

0

Dermatitis acneiform

42 (31)

1 (1)

41 (30)

1 (1)

Epistaxis

42 (31)

1 (1)

27 (20)

0

Decreased appetite

39 (28)

5 (4)

28 (20)

4 (3)

Paronychia

36 (26)

2 (1)

32 (23)

2 (1)

Pruritus

35 (26)

1 (1)

32 (23)

1 (1)

COVID-19

34 (25)

0

0

0

Weight decreased

30 (22)

2 (1)

21 (15)

0

Cough

30 (22)

1 (1)

2 (1)

0

Increased ALT

29 (21)

7 (5)

24 (18)

7 (5)

Hypokalemia

29 (21)

4 (3)

15 (11)

3 (2)

Diarrhea

29 (21)

2 (1)

14 (10)

1 (1)

Eczema

25 (18)

2 (1)

22 (16)

2 (1)

Hypocalcemia

22 (16)

2 (1)

13 (9)

1 (1)

Erythema

20 (15)

2 (1)

18 (13)

1 (1)

Photosensitivity reaction

19 (14)

1 (1)

19 (14)

1 (1)

Decreased growth velocity

18 (13)

7 (5)

17 (12)

7 (5)

Increased bilirubin

18 (13)

1 (1)

16 (12)

1 (1)

Hyponatremia

17 (12)

3 (2)

4 (3)

1 (1)

Erythematous rash

14 (10)

1 (1)

14 (10)

1 (1)

Decreased WBC count

13 (9)

2 (1)

11 (8)

1 (1)

Tumor hemorrhage

12 (9)

5 (4)

10 (7)

3 (2)

Decreased neutrophil count

12 (9)

4 (3)

9 (7)

3 (2)

Seizure

11 (8)

6 (4)

1 (1)

1 (1)

Weight increased

10 (7)

2 (1)

6 (4)

1 (1)

Lethargy

9 (7)

1 (1)

6 (4)

1 (1)

Pericardial effusion

9 (7)

1 (1)

5 (4)

1 (1)

Decreased phosphorus

7 (5)

1 (1)

5 (4)

1 (1)

Folliculitis

5 (4)

1 (1)

4 (3)

1 (1)

Prolonged APTT

3 (2)

1 (1)

2 (1)

1 (1)

Increased GGT

3 (2)

1 (1)

1 (1)

1 (1)

Systemic infection

2 (1)

2 (1)

1 (1)

1 (1)

Follicular rash

2 (1)

1 (1)

2 (1)

1 (1)

Optic nerve disorder

2 (1)

1 (1)

1 (1)

1 (1)

CSF circulation disorder

1 (1)

1 (1)

1 (1)

1 (1)

Cholecystitis

1 (1)

1 (1)

1 (1)

1 (1)

Eye infection viral

1 (1)

1 (1)

1 (1)

1 (1)

Pruritic rash

1 (1)

1 (1)

1 (1)

1 (1)

  1. TEAEs, TRAEs and laboratory abnormalities in ≥20% of patients and all TRAEs grade ≥3 occurring in ≥1 patient are reported. Patients are counted only once per event and are shown in the worst CTCAE grade that was reported for each event they experienced. MedDRA version 23.1; CTCAE version 5.0. APTT, activated partial thromboplastin time; AST, aspartate aminotransferase; COVID-19, coronavirus disease 2019; CSF, cerebrospinal fluid; GGT, gamma-glutamyl transferase; LDH, lactate dehydrogenase; RTI, respiratory tract infection; WBC, white blood cell.
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