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Table 4 Adverse events

From: A prospective clinical trial on sorafenib treatment of hepatocellular carcinoma before liver transplantation

Type of adverse event

Total N AEs/ subjects

Reason stop

Reason modi-fication

AEs CTC gr 3

AEs CTC gr 2

AEs CTC gr 1

Median days to AE (range)

Leucopenia

2/2

1

0

1

1

51 (13–88)

GI disorders

17/7

2 b

4

2

9

6

 

Diarrhea

12/7

2b

4

2

6

4

61 (0–305)

Nausea

3/3

   

1

2

4 (0–7)

Ulcer

2/2

   

2

 

65 (7–123)

General disorders

35/11

3 b,c

10

4

13

18

 

Fatigue

9/9

1

3

1

3

5

7 (0–54)

Loss of appetite

7/6

 

1

1

2

4

7 (3–139)

Weight problem

2/2

    

2

65 (15–112)

Pain

11/8

2a,b,c

4

2

2

7

11 (0–139)

Hypertension

6/6

 

1

 

6

 

18 (7–193)

Hepatobiliary disorders

5/4

1

3

0

2

2

7 (6–85)

Dermatologic disorders

31/10

1

7

1

12

18

15 (4–145)

Other

33/11

3 c

2

1

12

20

 

Hoarseness

2/2

    

2

17 (13–21)

Eyes and Vision

5/4

1c

1

1

2

2

9 (3–61)

Headache

2/2

   

2

 

Infection/fever

6/6

1c

  

4

2

13 (3–167)

Other related

8/5

1c

1

 

3

5

Other not related

10/7

   

1

9

 

Serious adverse event

0/0

0

0

0

0

0

 

TOTAL events/patients:

123/ 12

  

8/ 3

49/12

65/11

 
  1. aabdominal pain, bone patient had dual reasons for stopping treatment, cseveral adverse events led to treatment stop in one patient
  2. Adverse events (AEs) according to CTC v4.0 during sorafenib treatment. ‘Reason stop’ refers to the number of patients who stopped sorafenib treatment permanently because of an adverse event, while reason ‘Reason modification’ corresponds to the number of times an adverse event led to a treatment pause or dose modification. Some adverse events occurred several times in the same patients, which is why the total number of AEs is higher. The subgroups of Gastrointestinal disorders, General disorders and Other are in italics
  3. Bold figures are the sums of the subgroups (in italics)