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Table 2 Adverse events (all grades [≥10%] and grades 3/4, regardless of causality) by treatment group

From: A phase I open-label dose-escalation study of the anti-HER3 monoclonal antibody LJM716 in patients with advanced squamous cell carcinoma of the esophagus or head and neck and HER2-overexpressing breast or gastric cancer

Preferred term, n (%) 3 mg/kg QW
n = 1
10 mg/kg QW
n = 5
20 mg/kg QW
n = 6
40 mg/kg QW
RDE, n = 36
20 mg/kg Q2W
n = 6
All patients N = 54
  All grades Grade 3/4 All grades Grade 3/4 All grades Grade 3/4 All grades Grade 3/4 All grades Grade 3/4 All grades Grade 3/4
Diarrhea 0 0 2 (40) 0 5 (83) 1 (17) 18 (50) 1 (3) 3 (50) 1 (17) 28 (52) 3 (6)
Decreased appetite 0 0 3 (60) 0 4 (67) 0 16 (44) 0 1 (17) 0 24 (44) 0
Pyrexia 0 0 2 (40) 0 2 (33) 0 18 (50) 1 (3) 0 0 22 (41) 1 (2)
Fatigue 0 0 2 (40) 0 2 (33) 1 (17) 14 (39) 0 1 (17) 0 19 (35) 1 (2)
Nausea 1 (100) 0 3 (60) 0 3 (50) 1 (17) 12 (33) 1 (3) 0 0 19 (35) 2 (4)
Infusion-related reaction 0 0 0 0 3 (50) 0 13 (36) 0 1 (17) 0 17 (31) 0
Vomiting 1 (100) 0 1 (20) 0 2 (33) 1 (17) 10 (28) 2 (6) 2 (33) 0 16 (30) 3 (6)
Constipation 1 (100) 0 0 0 3 (50) 0 10 (28) 0 1 (17) 0 15 (28) 0
Dyspnea 0 0 1 (20) 0 1 (17) 1 (17) 10 (28) 2 (6) 3 (50) 1 (17) 15 (28) 4 (7)
Anemia 0 0 1 (20) 0 3 (50) 1 (17) 10 (28) 6 (17) 0 0 14 (26) 7 (13)
Hypomagnesemia 0 0 3 (60) 0 5 (50) 0 7 (19) 0 1 (17) 0 14 (26) 0
Hypokalemia 1 (100) 0 2 (40) 0 0 0 9 (25) 4 (11) 1 (17) 0 13 (24) 4 (7)
Chills 0 0 0 0 2 (33) 0 11 (31) 0 0 0 13 (24) 0
Cough 0 0 1 (20) 0 1 (17) 0 8 (22) 0 1 (17) 0 11 (20) 0
Headache 0 0 2 (40) 0 1 (17) 0 7 (19) 0 0 0 10 (19) 0
Stomatitis 0 0 0 0 2 (33) 0 7 (19) 0 1 (17) 0 10 (19) 0
AST increased 0 0 2 (40) 0 1 (17) 0 6 (17) 0 0 0 9 (17) 0
Asthenia 0 0 0 0 2 (33) 1 (17) 5 (14) 1 (3) 2 (33) 1 (17) 9 (17) 3 (6)
Myalgia 0 0 0 0 1 (17) 0 7 (19) 0 1 (17) 0 9 (17) 0
Blood ALP increased 1 (100) 0 1 (20) 0 2 (33) 0 4 (11) 2 (6) 0 0 8 (15) 2 (4)
Hypophosphatemia 0 0 0 0 0 0 8 (22) 5 (14) 0 0 8 (15) 5 (9)
Pruritus 0 0 1 (20) 0 1 (17) 0 5 (14) 0 1 (17) 0 8 (15) 0
Pneumonia 0 0 0 0 0 0 8 (22) 6 (17) 0 0 8 (15) 6 (11)
Rash 0 0 0 0 1 (17) 0 6 (17) 0 1 (17) 0 8 (15) 0
Abdominal pain 0 0 0 0 0 0 6 (17) 1 (3) 1 (17) 0 7 (13) 1 (2)
Dehydration 0 0 1 (20) 0 2 (33) 1 (17) 4 (11) 2 (6) 0 0 7 (13) 3 (6)
Dry skin 0 0 1 (20) 0 2 (33) 0 4 (11) 0 0 0 7 (13) 0
Hypoalbuminemia 0 0 0 0 3 (50) 0 4 (11) 0 0 0 7 (13) 0
Peripheral edema 0 0 1 (20) 0 1 (17) 0 4 (11) 0 1 (17) 0 7 (13) 0
Weight decreased 0 0 1 (20) 0 2 (33) 0 4 (11) 0 0 0 7 (13) 0
Pleural effusion 0 0 1 (20) 1 (20) 0 0 4 (11) 1 (3) 1 (17) 1 (17) 6 (11) 3 (6)
Muscular weakness 0 0 1 (20) 0 1 (17) 0 2 (6) 0 2 (33) 0 6 (11) 0
  1. ALP alkaline phosphatase, AST aspartate aminotransferase, Q2W once every two weeks, QW once weekly, RDE recommended dose for expansion