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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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