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Table 3 Adverse events irrespective of suspected causality with everolimus that occurred in ≥5% of patients (safety population, n = 318)

From: Everolimus in metastatic renal cell carcinoma after failure of initial anti–VEGF therapy: final results of a noninterventional study

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)

  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%).