TABLE 2

Investigator-reported adverse events in the safety population

Adverse eventsProportion of patients with adverse event %
Total adverse events reported22455.7
GI events173
 Diarrhoea11045.0
 Nausea/vomiting2610.7
 Anorexia187.4
 Abdominal pain114.5
 Dyspepsia/bloating62.5
 GI bleeding20.8
 Reduced body weight166.6
Liver function test elevations124.9
Weakness114.5
Ischaemic events#92.9
Hyperpyrexia10.4
Others41.6
Reduced dose due to adverse event6928.3
Discontinuation due to adverse event3213.1

GI: gastrointestinal. #: myocardial infarction or ischaemic stroke.