Skip to main content

Table 2 Drug-related adverse events reported in ≥ 10% of patients during the treatment period

From: First-in-human phase I dose-escalation and dose-expansion trial of the selective MEK inhibitor HL-085 in patients with advanced melanoma harboring NRAS mutations

 

Total

Grade 1

Grade 2

Grade 3

Grade 4

Preferred term

12 mg twice daily (n = 15)

All doses (n = 42)

12 mg twice daily (n = 15)

All doses (n = 42)

12 mg twice daily (n = 15)

All doses (n = 42)

12 mg twice daily (n = 15)

All doses (n = 42)

12 mg twice daily (n = 15)

All doses (n = 42)

Adverse events related to study drug

15 (100%)

36 (85.7%)

0

6 (14.3%)

6 (40.0%)

14 (33.3%)

7 (46.7%)

13 (31.0%)

2 (13.3%)

3 (7.1%)

Rash

7 (46.7%)

26 (61.9%)

6 (40.0%)

21 (50.0%)

1 (6.7%)

5 (11.9%)

0

0

0

0

Increased creatine phosphokinase

13 (86.7%)

25 (59.5%)

3 (20.0%)

6 (14.3%)

6 (40.0%)

13 (31.0%)

2 (13.3%)

3 (7.1%)

2 (13.3%)

3 (7.1%)

Face edema

12 (80.0%)

21 (50.0%)

11 (73.3%)

19 (45.2%)

0

1 (2.4%)

1 (6.7%)

1 (2.4%)

0

0

Increased aspartate aminotransferase

10 (66.7%)

20 (47.6%)

9 (60.0%)

19 (45.2%)

1 (6.7%)

1 (2.4%)

0

0

0

0

Peripheral edema

9 (60.0%)

17 (40.5%)

6 (40.0%)

14 (33.3%)

1 (6.7%)

1 (2.4%)

2 (13.3%)

2 (4.8%)

0

0

Diarrhea

7 (46.7%)

14 (33.3%)

5 (33.3%)

11 (26.2%)

2 (13.3%)

2 (4.8%)

0

1 (2.4%)

0

0

Increased alanine aminotransferase

6 (40.0%)

14 (33.3%)

5 (33.3%)

13 (31.0%)

1 (6.7%)

1 (2.4%)

0

0

0

0

Paronychia

5 (33.3%)

8 (19.0%)

5 (33.3%)

7 (16.7%)

0

1 (2.4%)

0

0

0

0

Asthenia

4 (26.7%)

7 (16.7%)

2 (13.3%)

3 (7.1%)

1 (6.7%)

1 (2.4%)

1 (6.7%)

3 (7.1%)

0

0

Dermatitis acneiform

4 (26.7%)

6 (14.3%)

2 (13.3%)

3 (7.1%)

1 (6.7%)

1 (2.4%)

1 (6.7%)

2 (4.8%)

0

0

Increased creatine phosphokinase MB

3 (20.0%)

6 (14.3%)

3 (20.0%)

4 (9.5%)

0

2 (4.8%)

0

0

0

0

Proteinuria

4 (26.7%)

6 (14.3%)

3 (20.0%)

4 (9.5%)

1 (6.7%)

2 (4.8%)

0

0

0

0

Skin fissures

4 (26.7%)

5 (11.9%)

4 (26.7%)

5 (11.9%)

0

0

0

0

0

0

Pyrexia

4 (26.7%)

5 (11.9%)

2 (13.3%)

3 (7.1%)

1 (6.7%)

1 (2.4%)

1 (6.7%)

1 (2.4%)

0

0

Decreased white blood cell count

2 (13.3%)

5 (11.9%)

1 (6.7%)

3 (7.1%)

1 (6.7%)

2 (4.8%)

0

0

0

0

Decreased neutrophil count

2 (13.3%)

5 (11.9%)

1 (6.7%)

3 (7.1%)

1 (6.7%)

2 (4.8%)

0

0

0

0

Anemia

4 (26.7%)

5 (11.9%)

2 (13.3%)

3 (7.1%)

2 (13.3%)

2 (4.8%)

0

0

0

0

  1. Data are number of patients (%)