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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)