Table 4.
Adverse events leading to discontinuation of study treatment
| Adverse event (%) | EVE + EXE (n = 482) |
PBO + EXE (n = 238) |
||||
|---|---|---|---|---|---|---|
| All grades | Grade 1/2 | Grade 3/4 | All grades | Grade 1/2 | Grade 3/4 | |
| Pneumonitis | 5.6 | 3.7 | 1.9 | 0 | 0 | 0 |
| Stomatitis | 2.7 | 1.9 | 0.8 | 0.4 | 0 | 0.4 |
| Rash | 1.7 | 1.0 | 0.6 | 0 | 0 | 0 |
| Dyspnea | 2.3 | 0.8 | 1.5 | 0 | 0 | 0 |
| Fatigue | 1.9 | 1.0 | 0.8 | 0 | 0 | 0 |
| Asthenia | 0.8 | 0.4 | 0.4 | 0 | 0 | 0 |
| Lung infection | 0 | 0 | 0 | 0.4 | 0 | 0.4 |
| Thrombocytopenia | 0.4 | 0.4 | 0 | 0 | 0 | 0 |
| Hyperglycemia | 0.2 | 0 | 0.2 | 0 | 0 | 0 |
EVE, everolimus; EXE, exemestane; PBO, placebo.