Table 3 Adverse events reported in ⩾10% of patients in the safety population (N=43), regardless of relationship to study drug

From: Everolimus as second- or third-line treatment of advanced endometrial cancer: ENDORAD, a phase II trial of GINECO

Event, n (%)

Any grade

Grade 3/4

Non-haematologic

Fatigue

40 (93)

18 (42)

Nausea

22 (51)

4 (9)

Cutaneous rasha

21 (49)

2 (5)

Mucositis

21 (49)

4 (9)

Vomiting

21 (49)

4 (9)

Anorexia

20 (47)

11 (26)

Diarrhoea

19 (44)

5 (12)

Infection

18 (42)

7 (16)

Constipation

14 (33)

1 (2)

Oedema

12 (28)

1 (2)

Dyspnoea

8 (19)

1 (2)

Haemorrhage

8 (19)

0

Thromboembolism

7 (16)

5 (12)

Pneumonitis

5 (12)b

2 (5)c

Haematologic

Anaemia

43 (100)

6 (14)

Lymphopenia

35 (81)

10 (23)

Leucopenia

21 (49)

2 (5)

Neutropenia

15 (35)

1 (2)

Thrombocytopenia

9 (21)

2 (5)

Biochemical d

Hypercholesterolaemia

30 (81)

3 (8)

Hypertriglyceridemia

27 (69)

—

Hyperglycaemia

25 (61)

4 (10)

Elevated ALT

20 (48)

—

Elevated AST

15 (36)

—

Hypercalcemia

6 (14)

—

  1. Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase.
  2. aIncludes rash, pruritus, erythema, and dry skin.
  3. bAll cases of pneumonitis were interstitial except for 1 case of infectious pneumonitis.
  4. cOne case each of interstitial and infectious pneumonitis.
  5. dn=42 for ALT, AST, and hypercalcemia; 41 for hyperglycaemia; 39 for hypertriglyceridemia; and 37 for hypercholesterolaemia.
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