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Table 4 Treatment-related adverse events occurring in mCRC patients during the study in the safety analysis set

From: Famitinib versus placebo in the treatment of refractory metastatic colorectal cancer: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial

Adverse event

Famitinib group [cases (%)] (n = 99)

Placebo group [cases (%)] (n = 55)

Any grade

Grade 3–4

Any grade

Grade 3–4

Any eventa

92 (92.9)

51 (51.5)

42 (76.4)

20 (36.4)

Clinical adverse event

 Hypertension

38 (38.4)

11 (11.1)

4 (7.3)

1 (1.8)

 Hand-foot syndrome

27 (27.3)

10 (10.1)

1 (1.8)

0 (0.0)

 Diarrhea

15 (15.2)

1 (1.0)

3 (5.5)

0 (0.0)

 Fatigue

14 (14.1)

3 (3.0)

9 (16.4)

2 (3.6)

 Rash

8 (8.1)

2 (2.0)

0 (0.0)

0 (0.0)

 Hypothyroidism

7 (7.1)

0 (0.0)

1 (1.8)

0 (0.0)

 Oral mucositis

7 (7.1)

0 (0.0)

0 (0.0)

0 (0.0)

 Nausea

6 (6.1)

0 (0.0)

4 (7.3)

1 (1.8)

 Decrease appetite

6 (6.1)

0 (0.0)

5 (9.1)

0 (0.0)

 Headache

6 (6.1)

1 (1.0)

2 (3.6)

1 (1.8)

 Vomit

5 (5.1)

1 (1.0)

2 (3.6)

1 (1.8)

 Dizziness

5 (5.1)

0 (0.0)

2 (3.6)

0 (0.0)

 Backache

3 (3.0)

0 (0.0)

3 (5.5)

0 (0.0)

 Abdominal distension

2 (2.0)

0 (0.0)

3 (5.5)

0 (0.0)

 Cough

2 (2.0)

0 (0.0)

5 (9.1)

0 (0.0)

Laboratory abnormalities

 Proteinuria

42 (42.4)

6 (6.1)

9 (16.4)

0 (0.0)

 Neutropenia

41 (41.4)

9 (9.1)

1 (1.8)

1 (1.8)

 Leukopenia

36 (36.4)

3 (3.0)

1 (1.8)

0 (0.0)

 Thrombocytopenia

31 (31.3)

10 (10.1)

1 (1.8)

1 (1.8)

 Increased γ-GT

20 (20.2)

7 (7.1)

11 (20.0)

7 (12.7)

 Increased ALT

17 (17.2)

3 (3.0)

8 (14.5)

1 (1.8)

 Increased AST

16 (16.2)

2 (2.0)

7 (12.7)

0 (0.0)

 Increased ALP

14 (14.1)

0 (0.0)

6 (10.9)

2 (3.6)

 Hypercholesterolemia

11 (11.1)

0 (0.0)

2 (3.6)

0 (0.0)

 Hypertriglyceridemia

11 (11.1)

0 (0.0)

2 (3.6)

0 (0.0)

 Anemia

7 (7.1)

0 (0.0)

4 (7.3)

1 (1.8)

 Increase bilirubin

5 (5.1)

1 (1.0)

1 (1.8)

0 (0.0)

 Hyperglycemia

1 (1.0)

0 (0.0)

3 (5.5)

1 (1.8)

  1. γ-GT γ-glutamyltranspeptidase, ALT alanine transaminase, AST aspartate transaminase, ALP alkaline phosphatase
  2. aSome patients had experienced several AEs