Table 3.
Adverse events irrespective of suspected causality with everolimus that occurred in ≥5% of patients (safety population, n = 318)
| Adverse eventa | All events, n (%) | Serious events, n (%) |
|---|---|---|
| Overall | 224 (70) | 125 (39) |
| Dyspnea | 54 (17) | 31 (10) |
| Anemia | 46 (15) | 21 (7) |
| Fatigue | 37 (12) | 13 (4) |
| Cough | 33 (10) | 19 (6) |
| Nausea | 28 (9) | 6 (2) |
| Pain | 24 (8) | 6 (2) |
| General physical health deterioration | 23 (7) | 19 (6) |
| Stomatitis | 22 (7) | 4 (1) |
| Peripheral edema | 21 (7) | 10 (3) |
| Mucositis | 19 (6) | 1 (<1) |
| Pyrexia | 19 (6) | 11 (4) |
| Rash | 18 (6) | 4 (1) |
| Decreased appetite | 17 (5) | 1 (<1) |
| Diarrhea | 16 (5) | 5 (2) |
| Decreased weight | 16 (5) | 4 (1) |
aDisease progression was collected as an adverse event according to the requirement of observational plan. Progression-related events (neoplasm progression, malignant neoplasm, malignant neoplasm progression) were summarized under the preferred term “neoplasm progression”. Neoplasm progression was reported as an adverse event for 57 patients (18%) and as a serious event for 54 patients (17%).