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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