TABLE 6

Summary of adverse events (AEs) suspected of being related to the study drug

EventAny grade (n=208)Severe (n=208)
Any AE138 (66.3)105 (50.3)
Any AE considered to be drug related118 (56.7)74 (35.6)
Drug reduction and/or interruption67 (32.2)
Drug discontinuation13 (6.3)
Most common AEs
 Diarrhoea46 (22.1)12 (5.8)
 Nausea35 (16.8)11 (5.3)
 Vomiting34 (16.3)11 (5.3)
 Hepatic toxicity (ALT/AST-increased or other)41 (19.7)26 (12.5)
 Abdominal pain12 (5.8)1 (0.5)
 Weight decrease12 (5.8)5 (2.4)
 Asthenia10 (4.8)7 (3.4)
 Decreased appetite9 (4.3)5 (2.4)
 Creatinine increase/renal insufficiency14 (6.7)8 (3.8)
 Fatigue6 (2.9)2 (1.0)
 Pericardial tamponade/effusion5 (2.4)3 (1.4)
 Hyperglycaemia3 (1.4)2 (1.0)
 Dyspnoea3 (1.4)3 (1.4)
 Thrombocytopenia4 (1.9)3 (1.4)
 Skin disorders2 (1.0)0 (0.0)
 Dehydration2 (1.0)2 (1.0)

Data are presented as n (%). ALT: alanine aminotransferase; AST: aspartate aminotransferase.