Table 4.
Most Frequently Reported Grades 3 to 4 Study Drug–Related Adverse Events
| Adverse Event | Patients by Imatinib Dose |
|||
|---|---|---|---|---|
| 400 mg (n = 157) |
800 mg (n = 319) |
|||
| No. | % | No. | % | |
| Nonhematologic* | ||||
| Nausea | 0 | 4 | 1.3 | |
| Periorbital edema | 0 | 3 | 0.9 | |
| Diarrhea | 0 | 8 | 2.5 | |
| Peripheral edema | 0 | 2 | 0.6 | |
| Rash | 4 | 2.5 | 18 | 5.7 |
| Muscle spasms | 1 | 0.6 | 3 | 0.9 |
| Fatigue | 3 | 1.9 | 5 | 1.6 |
| Vomiting | 1 | 0.6 | 3 | 0.9 |
| Arthralgia | 1 | 0.6 | 6 | 1.9 |
| Myalgia | 0 | 11 | 3.5 | |
| Face edema | 0 | 2 | 0.6 | |
| Pain in extremity | 0 | 7 | 2.2 | |
| Headache | 0 | 5 | 1.6 | |
| Eyelid edema | 0 | 2 | 0.6 | |
| Dyspepsia | 0 | 0 | ||
| Dizziness | 0 | 3 | 0.9 | |
| Hematologic† | ||||
| Leukopenia | 12 | 7.6 | 45 | 14.2 |
| Neutropenia | 29 | 18.5 | 90 | 28.5 |
| Thrombocytopenia | 16 | 10.2 | 57 | 18.0 |
| Anemia | 6 | 3.8 | 22 | 7.0 |
| Laboratory abnormalities† | ||||
| Hypophosphatemia | 23 | 14.6 | 38 | 12.0 |
| Hypocalcemia | 6 | 3.8 | 4 | 1.3 |
| Transaminase elevation | 7 | 4.5 | 9 | 2.8 |
| Alkaline phosphatase | 0 | 1 | 0.3 | |
| ALT | 7 | 4.5 | 8 | 2.5 |
| AST | 5 | 3.2 | 5 | 1.6 |
| Albumin | 0 | 1 | 0.3 | |
| Creatinine | 0 | 1 | 0.3 | |
| Total bilirubin | 0 | 0 | ||
| Hypercalcemia | 1 | 0.6 | 0 | |
NOTE. Most frequent adverse events occurred in at least 10% of patients from either treatment group.
*
Most frequently reported nonhematologic adverse events determined by the investigator to be study drug related.
†
Newly occurring or worsening abnormalities on the basis of laboratory values.