Table 4.
Grade 3 or 4 Adverse Events According to Renal Function That Occurred in >10% of Patients
| Adverse Event | Mild or No RI: CLCr ≥60 mL/min | Moderate RI: CLCr ≥30 mL/min to <60 mL/min | Severe RI: CLCr <30 mL/min |
|---|---|---|---|
| Total no. of patients | 243 | 82 | 16 |
| Hematologic toxicities, % | |||
| Neutropenia | 32 | 48a | 38 |
| Thrombocytopenia | 9 | 22a | 38a |
| Anemia | 5 | 21a | 44a |
| Nonhematologic toxicities, % | |||
| Thrombotic eventsb | 13 | 15 | 6 |
| Hypertension NOS | 0.8 | 2 | 13 |
| Atrial fibrillation | 3 | 4 | 13 |
| Fatigue | 5 | 12a | 0 |
| Asthenia | 4 | 5 | 13 |
| Constipation | 2 | 1 | 13 |
| Hypocalcemia | 3 | 6 | 19 |
| Dehydration | 0.8 | 2a | 13a |
| Pneumonia NOS | 7 | 9 | 25a |
| Clinically important adverse events, % | |||
| Febrile neutropenia | 3 | 2 | 0 |
| Neuropathy | 2 | 2 | 0 |
| Peripheral neuropathy | 2 | 1 | 0 |
RI indicates renal impairment; CLCr, creatinine clearance; NOS, not otherwise specified.
a
P < .05 versus patients with mild or no RI.
b
Thrombotic events included pulmonary embolism, deep vein thrombosis, and venous thrombosis NOS.