Table 5.
Adverse events associated with everolimus in Phase III trials
| Adverse event | RADIANT-242
|
RADIANT-344
|
RADIANT-447
|
|||
|---|---|---|---|---|---|---|
| All grades (%) | Grades 3–4 (%) | All grades (%) | Grades 3–4 (%) | All grades (%) | All grades (%) | |
| Stomatitis | 62 | 7 | 64 | 7 | 63 | 9 |
| Rash | 37 | 1 | 49 | <1 | 27 | <1 |
| Diarrhea | 27 | 6 | 34 | 3 | 31 | 3 |
| Fatigue | 31 | 7 | 31 | 2 | 31 | 2 |
| Infections | 20 | 5 | 23 | 2 | 29 | 7 |
| Nausea | 20 | <1 | 20 | 2 | 17 | 2 |
| Peripheral edema | 13 | 0 | 20 | <1 | 26 | 2 |
| Decreased appetite | 13 | 0 | 20 | 0 | 16 | <1 |
| Headache | – | – | 19 | 0 | – | – |
| Dysgeusia | 17 | <1 | 17 | 0 | 15 | <1 |
| Anemia | 15 | 1 | 17 | 6 | 16 | 4 |
| Epistaxis | – | – | 17 | 0 | – | – |
| Pneumonitis | 8 | – | 17 | 2 | 16 | 1 |
| Weight loss | 15 | <1 | 16 | 0 | – | – |
| Vomiting | 11 | <1 | 15 | 0 | – | – |
| Pruritus | 11 | 0 | 15 | 0 | 13 | <1 |
| Hyperglycemia | 15 | 5 | 13 | 5 | 10 | 3 |
| Thrombocytopenia | 14 | 5 | 13 | 4 | – | – |
| Asthenia | 10 | 1 | 13 | 1 | 16 | 2 |
| Nail disorder | – | – | 12 | <1 | – | – |
| Cough | – | – | 11 | 0 | 13 | 0 |
Note: Dash indicates not reported.
Abbreviation: RADIANT, RAD001 in Advanced Neuroendocrine Tumors.