Table 2.
Hematologic and Nonhematologic Toxicity
| Toxicity | Placebo, % (n = 99) |
Sunitinib, % (n = 99) |
||
|---|---|---|---|---|
| All Grade | Grade III/V | All Grade | Grade III/V | |
| Hematologic | ||||
| Neutropenia | 1 | 1/0 | 12a | 7/0a |
| Thrombocytopenia | 1 | 0/0 | 18a | 11/1a |
| Anemia | 1 | 0/0 | 14a | 6/0a |
|
| ||||
| Nonhematologic | ||||
| Nausea | 18 | 1/0 | 41a | 2/1 |
| Vomiting | 1 | 1/0 | 7a | 0/1 |
| Mucositis | 5 | 0/0 | 35a | 11/0a |
| Diarrhea | 12 | 0/0 | 44a | 2/0 |
| Anorexia | 15 | 0/0 | 36a | 3/0 |
| Rash | 8 | 0/0 | 28a | 11/0a |
| Neuropathy | 2 | 0/0 | 5 | 2/0 |
| Hypertension | 9 | 0/0 | 27a | 12/0a |
| Fatigue | 56 | 4/0 | 71a | 23/2a |
| Hemorrhage, GI | 0 | 0/0 | 3 | 3/0 |
| Hemorrhage, pulmonary | 1 | 0/0 | 8a | 0/0 |
| Hypothyroidism | 3 | 0/0 | 6 | 0/0 |
Note: There were three grade 5 events in patients receiving sunitinib (one pulmonary hemorrhage, one other pulmonary event, and one death not associated with a Common Terminology Criteria for Adverse Events term). There were two grade 5 events in patients receiving placebo (one other pulmonary event and one thromboembolism).
a
p < 0.05.
GI, gastrointestinal.