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Table 7b. Percentages of Patients Reporting Adverse Events on Imatinib Dose and Grade (gd)a

Adverse Event

Verweij, et al., 2004

van Oosterom, et al., 2001b

van Oosterom, et al., 2002c

Grade

gd1-gd2%

gd3-gd4%

gd1-gd2%

gd3-gd4%

% of patients who experience relevant side effect

gd1-gd2%

gd3-gd4%

Drug

Imatinib

Imatinib

Imatinib

Imatinib

Dosage

400 mg

800 mg

400 mg
N=8

600 mg
N=8

800 mg
N=16

1000 mg
N=8

Across dose ranges (400-1000 mg)

Any adverse event with suspected relation to study drug

67

36

49

51

               

Edema or fluid retention

23

14

78

9

0

25

31

38

   

10

 

Superficial edema

                               

Pleural effusion or ascites

                           

3

Periorbital

                         

40 (not graded)

   

Leg

                           

38

 

Face

                               

Other site

                               

Eyelid

                               

Hemorrhage

8

0

15

8

               

Tumor hemorrhage

                               

Cerebral hemorrhage

                               

Upper GI tract

                               

Hematologic

                               

Anemia

55

27

10

1

81

17

           

12

 

Neutropenia/ granulocytopenia

20

13

0.04

3

36

7

           

17

Leukopenia

27

13

0.03

0

45

2

           

10

 

Thrombocytopenia

4

0

0

0

5

0

       

3

     

Digestive

                               

Diarrhea

46

1

17

1

         

15

   

Flatulence

                               

Vomiting

23

0

36

3

25

0

6

25

   

25

 

Abdominal pain

                               

Vomiting

23

0

36

3

25

0

6

25

   

25

 

Dyspepsia

                               

Loose stools

                               

Constipation

11

4

0.01

0

17

1

               

Taste disturbance

                               

Abdominal distension

           

2

               

Esophageal reflux

                               

Nasopharyngitis

                               

Skin

                               

Pruritus

12

4

0

0

15

8

1

0

               

Photosensitivity

                               

Dermatitis or rash

24

0

42

6

0

13

25

25

   

30

 

Whole body

                               

Fatigue

62

1

69

12

           

30

 

Headache

16

0

13

1

               

Arthralgia

11

2

0

0

15

1

               

Pain

                               

Blurred vision

                               

Pyrexia

8

3

0.01

0

13

3

1

0

               

Insomnia

                               

Chills

                               

Increased lacrimation

                               

Anorexia

16

8

0.02

0

25

13

8

0

       

15

   

Dizziness

9

1

0

0

11

2

0.004

0

               

Cough

11

2

0

0

11

3

1

0

               

Dyspnea

0

8

0.03

0

0

13

3

1

0

0

0

13

       

Muscle cramps

                               

Myalgia or musculoskeletal pain

25

0

26

0

               

Infection

                               

Infection

7

7

0.03

0

9

8

4

0

               

Neutropenic fever

               

0

0

6

0

       

Upper respiratory tract infection

                               

Neurologic

                               

Paresthesia

                               

Metabolic

                           

Renal or genitourinary

9

3

0

0

48

5

2

0.6

               

Abnormal liver-function results

                               

Notes:
a. Table 7b represents data from studies by Verweij, et al.,  2004;  van Oosterom, et al.,  2001; van Oosterom, et al. , 2002.
b. Most relevant side effects (gd 2 and 3) during first 8 wks.
c. Update on 2001 paper with data at 8 months.

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