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

Adverse Event

Demetri, et al.

Dagher
(representation of Demetri, et al., 2002 data)b

Verweij, et al., 2003

Grade

Any grade%

Grade 3 or 4%

Any grade%

Grade 3 or 4%

Any  grade%

Grade 3 or 4%

Drug

Imatinib

Imatinib

Imatinib

Dosage

400 mg

600 mg

all pts

400 mg

600 mg

all pts

400 mg

600 mg

400 mg

600 mg

400 mg

400 mg

Any adverse event with suspected relation to study drug

97

99

98

21

22

21

           

Edema or fluid retention

71

77

74

1

1

1

71

76

6

3

84

0

superficial edema

           

71

76

4

0

   

Pleural effusion or ascites

           

6

4

1

3

   

periorbital

45

50

48

0

0

0

           

Leg

26

15

20

0

0

0

           

Face

8

12

10

1

0

1

           

Other site

7

14

10

0

0

0

           

Eyelid

7

8

8

0

0

0

           

Hemorrhage

11

14

12

4

5

5

18

19

5

8

53

4

Tumor hemorrhage

1

4

3

1

4

3

1

4

1

4

43

4

Cerebral hemorrhage

0

0

0

0

0

0

1

0

1

0

   

Upper GI tract

4

3

3

4

1

3

6

4

4

1

37

6

Hematologic

                       

Anemia

6

12

9

1

3

2

           

Neutropenia/ granulocytopenia

8

5

7

7

3

5

           

Leukopenia

6

4

5

3

0

1

           

Thrombocytopenia

                   

55

14

Digestive

                       

Diarrhea

40

50

45

1

3

2

56

60

1

4

   

Flatulence

19

24

22

0

0

0

16

23

0

0

   

Vomiting

14

12

13

0

1

1

22

23

1

3

   

Abdominal pain

26

26

26

1

0

1

37

37

7

3

   

Vomiting

14

12

13

0

1

1

22

23

1

3

   

Dyspepsia

10

12

11

0

0

0

           

Loose stools

7

10

8

0

0

0

           

Constipation

                       

Taste disturbance

3

14

8

0

0

0

1

14

0

0

   

Abdominal distension

6

5

5

0

0

0

           

Esophageal reflux

1

7

4

0

0

0

           

Nasopharyngitis

           

12

14

0

0

   

Skin

                       

Pruritus

3

5

4

0

0

0

           

Photosensitivity

0

5

3

0

0

0

       

33

6

Dermatitis or rash

25

37

31

3

3

3

26

38

3

3

80

12

Whole body

                       

Fatigue

30

39

35

0

0

0

33

38

1

0

   

Headache

19

32

26

0

0

0

25

35

0

0

41

4

Arthralgia

1

7

4

0

0

0

           

Pain

6

1

3

0

0

0

11

10

1

0

   

Blurred vision

6

1

3

0

0

0

       

20

 

Pyrexia

           

12

5

0

0

   

Insomnia

             

11

0

0

64

12

Chills

                       

Increased lacrimation

7

12

10

0

0

0

6

11

0

0

   

Anorexia

                       

Dizziness

                       

Cough

                       

Dyspnea

                       

Muscle cramps

           

30

41

0

0

   

Myalgia or musculoskeletal pain

37

42

40

0

0

0

19

11

3

0

   

Infection

                       

Neutropenic fever

                       

Upper respiratory tract infection

           

6

11

0

0

   

Neurologic

                       

Paresthesia

1

7

4

0

0

0

           

Metabolic

                       

Renal or genitourinary

                       

Abnormal liver-function results

6

5

5

3

3

3

           

Notes:
a. Table 7a represents data from studies by Demetri, et al., Dagher, and Verweij, et al., 2003.
b. All adverse events reported in this study were those that occurred in ≥ 10% of patients regardless of suspected relationship to treatment.

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