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Table 3 Safety profile and most common AEs occurring up to 9 December 2016: phase II part

From: A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer

Patients, n (%)

Xe1000+Ev10+Ex25 (n = 70)

Ev10+Ex25 (n = 69)

Any AE

70 (100.0)

68 (98.6)

Any grade ≥ 3 AE

39 (55.7)

31 (44.9)

Any TRAE

66 (94.3)

66 (95.7)

Any grade ≥ 3 TRAE

31 (44.3)

21 (30.4)

Any serious AE

15 (21.4)

20 (29.0)

Most common any-cause AEs

Any grade

Grade ≥ 3

Any grade

Grade ≥ 3

 Diarrhoea

29 (41.4)

1 (1.4)

20 (29.0)

1 (1.4)

 Mucosal inflammation

27 (38.6)

2 (2.9)

21 (30.4)

0

 Stomatitis

24 (34.3)

4 (5.7)

24 (34.8)

3 (4.3)

 Nausea

24 (34.3)

0

16 (23.2)

0

 Rash

23 (32.9)

0

21 (30.4)

0

 Cough

23 (32.9)

1 (1.4)

16 (23.2)

2 (2.9)

 Asthenia

21 (30.0)

1 (1.4)

24 (34.8)

2 (2.9)

 Fatigue

20 (28.6)

0

17 (24.6)

1 (1.4)

 Neutropenia

20 (28.6)

8 (11.4)

11 (15.9)

2 (2.9)

 Decreased appetite

18 (25.7)

1 (1.4)

21 (30.4)

0

 Hyperglycaemia

18 (25.7)

4 (5.7)

15 (21.7)

3 (4.3)

 Headache

17 (24.3)

0

9 (13.0)

0

 Thrombocytopenia

17 (24.3)

4 (5.7)

10 (14.5)

1 (1.4)

 ALT increased

16 (22.9)

3 (4.3)

10 (14.5)

1 (1.4)

 Anaemia

15 (21.4)

2 (2.9)

11 (15.9)

2 (2.9)

 Vomiting

14 (20.0)

2 (2.9)

13 (18.8)

0

 AST increased

13 (18.6)

3 (4.3)

13 (18.8)

0

 Epistaxis

13 (18.6)

0

9 (13.0)

1 (1.4)

 Platelet count decreased

13 (18.6)

1 (1.4)

3 (4.3)

0

 Constipation

13 (18.6)

1 (1.4)

6 (8.7)

0

 Pruritus

13 (18.6)

0

12 (17.4)

0

 Nasopharyngitis

12 (17.1)

0

6 (8.7)

0

 Hypophosphataemia

11 (15.7)

6 (8.6)

8 (11.6)

2 (2.9)

 Dysgeusia

11 (15.7)

0

10 (14.5)

0

 Dyspnoea

9 (12.9)

1 (1.4)

17 (24.6)

4 (5.8)

 Peripheral oedema

5 (7.1)

0

14 (20.3)

0

 Arthralgia

4 (5.7)

0

11 (15.9)

0

 Mouth ulceration

3 (4.3)

0

12 (17.4)

0

  1. AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, TRAE treatment-related adverse event. Most common AEs are those of any causality (≥ 15% of patients in either arm)