Table 6.
AEs | Percentage of Patients (No.) | ||
---|---|---|---|
All Patients During Study, N5551 |
Before Increase to ≥600 mg Daily, N5551 |
After Increase to ≥600 mg Daily, N567/After Increase to ≥800 mg Daily, N540 |
|
Nonhematologic AEs | |||
Fluid retention | 2.2 | 2 | 1.5 |
Other fluid retention | 1.1 | 1.1 | 1.1 |
Superficial edema | 1.1 | 0.9 | 1.5 |
Headache | 0.5 | 0.4 | 1.5 |
Abdominal pain | 3.6 | 3.1 | 4.5 |
Hemorrhage | 1.6 | 1.3 | 3 |
GI hemorrhage | 0.5 | 0.2 | 3 |
Pyrexia | 0.9 | 0.7 | 1.5 |
Grade 3 or 4 hematologic AEs | |||
Anemia | 4 (22) | 3.1 (17) | 7.5 (5)/7.5(3) |
Thrombocytopenia | 9.3 (51) | 8.2 (45) | 10.4 (7)/10 (4) |
AEs indicates adverse events; GI, gastrointestinal.