Table 7—

Adverse events by treatment arm

Total adverse events24/10334/1050.27
Gastro-intestinal adverse events#9/10327/1050.02
Frequency of four-fold increase from baseline in ALT4/1031/1040.21
Frequency of four-fold increase from baseline in AST2/1031/1031.00
  • Data are presented as n/total number of subjects, unless otherwise stated. ALT: alanine aminotransferase; AST: aspartate aminotransferase. #: gastro-intestinal adverse events of diarrhoea, nausea, abdominal symptoms, vomiting, constipation, pancreatitis, anorexia and weight loss; nongastro-intestinal adverse events of thrush, haemoptysis, headache, photosensitivity, rash, ocular surface irritation, dehydration, nightmares, difficulty concentrating, mood swings, hearing muffled, dry skin and hair, and pneumothorax.