Table 3.
Drug-Related AEs
| AE | FUL (n=124) | EVE-EXE (n=44) | ||
|---|---|---|---|---|
| Any Grade (%) | Grade 3/4 (%) | Any Grade (%) | ||
| Hematologic | ||||
| Anemia | 2 (1.6) | 0 | 6 (13.6) | 1 (2.7) |
| Thrombocytopenia | 0 | 0 | 5 (11.4) | 2 (4.5) |
| Leukopenia | 0 | 0 | 2 (4.5) | 0 |
| Non-Hematologic | ||||
| Stomatitis | 0 | 0 | 25 (56.8) | 5 (11.4) |
| Fatigue | 2 (1.6) | 0 | 11 (25) | 1 (2.3) |
| Infection | 0 | 0 | 11 (25) | 2 (4.5) |
| Rash | 0 | 0 | 8 (18.2) | 2 (2.4) |
| Edema | 1 (0.9) | 0 | 6 (13.6) | 0 |
| Cough | 0 | 0 | 6 (13.6) | 0 |
| Diarrhea | 0 | 0 | 5 (11.4) | 0 |
| Non-infectious pneumonitis | 0 | 0 | 5 (11.4) | 0 |
| Pyrexia | 0 | 0 | 4 (9.1) | 0 |
| Anorexia | 0 | 0 | 4 (9.1) | 0 |
| Hypertension | 0 | 0 | 3 (6.8) | 1 (2.3) |
| Weight loss | 0 | 0 | 2 (4.5) | 0 |
| Joint disorders | 6 (5.0) | 0 | 0 | 0 |
| Injection site reactions | 5 (4.0) | 0 | 0 | 0 |
| Gastrointestinal disturbances | 3 (2.4) | 0 | 0 | 0 |
| Hot flashes | 2 (1.6) | 0 | 0 | 0 |
| Biological events | 0 | 0 | ||
| Hyperglycemia | 2 (2.7) | 0 | 10 (22.7) | 0 |
| ALT increased | 6 (8.2) | 0 | 7 (15.9) | 1 (2.3) |
| AST increased | 6 (8.2) | 0 | 7 (15.9) | 0 |
| Hyperlipidemia | 0 | 0 | 4 (9.1) | 0 |
Abbreviations: AE, adverse events; FUL, fulvestrant; EVE-EXE, everolimus plus exemestane; ALT, alanine aminotransferase; AST, aspartate aminotransferase.