Table 3 Most frequently reported treatment-emergent adverse events (≥ 5% of patients; safety population)
Adverse event N = 67 n (%) | Safety population |
|---|---|
Any adverse event | 63 (94) |
Vomiting | 21 (31) |
Nausea | 19 (28) |
Diarrhoea | 17 (25) |
Blood Bilirubin Increased | 10 (15) |
Fatigue | 9 (13) |
Hyperhidrosis | 8 (12) |
Insomnia | 8 (12) |
Influenza | 7 (10) |
Weight Decreased | 7 (10) |
Abdominal Pain | 6 (9) |
Abdominal Pain Upper | 5 (7) |
Constipation | 5 (7) |
Hyperbilirubinaemia | 5 (7) |
Sleep Disorder | 5 (7) |
Cheilitis | 4 (6) |
Gastritis | 4 (6) |
Headache | 4 (6) |
Hepatic Enzyme Increased | 4 (6) |
Lower Respiratory Tract Infection | 4 (6) |
Oral candidiasis | 4 (6) |