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