Table 2.
National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 Grade 3 and 4 Adverse Events
| Toxicity | RAD001 (mg)
|
All
|
||||
|---|---|---|---|---|---|---|
| 5
|
10
|
|||||
| No | % | No | % | No | % | |
| No. of patients | 34 | 32 | 64 | |||
| Hematologic | ||||||
| Thrombocytopenia | 1 | 3 | 2 | 6 | 3 | 5 |
| Anemia | 1 | 3 | 1 | 3 | 2 | 3 |
| Leukopenia | 1 | 3 | 2 | 6 | 3 | 5 |
| Leukocytosis | 1 | 3 | 1 | 2 | ||
| Biochemical | ||||||
| Hyperglycemia | 1 | 3 | 5 | 16 | 6 | 9 |
| Hypertriglyceridemia | 2 | 6 | 2 | 3 | ||
| Hypoglycemia | 2 | 6 | 2 | 3 | ||
| Elevated AST | 1 | 3 | 2 | 6 | 3 | 5 |
| Hypophosphatemia | 2 | 6 | 5 | 16 | 7 | 11 |
| Elevated ALT | 3 | 9 | 3 | 5 | ||
| Hypokalemia | 1 | 3 | 1 | 3 | 2 | 3 |
| Hyperbilirubinemia | 1 | 3 | 1 | 2 | ||
| Other | ||||||
| Apthous ulcers* | 2 | 6 | 3 | 9 | 5 | 8 |
| Fatigue | 5 | 15 | 2 | 6 | 7 | 11 |
| Nausea | 1 | 3 | 1 | 2 | ||
| Nail changes | 1 | 3 | 1 | 2 | ||
| Diarrhea | 3 | 9 | 4 | 13 | 7 | 11 |
| Pain | 2 | 6 | 2 | 3 | ||
| Rash | 2 | 6 | 1 | 3 | 3 | 5 |
| Abdominal pain | 2 | 6 | 2 | 2 | ||
| Pruritus | 1 | 3 | 1 | 2 | ||
| Dysgeusia | 1 | 3 | 1 | 2 | ||
| Pneumonitis | 1 | 3 | 1 | 2 | ||
Abbreviation: RAD001, everolimus.
*
Graded as stomatitis under National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.