Table 2. Worst grade per patient of adverse events, irrespective of relationship to study drug, reported in the triweekly cohort.
| Adverse event | Any grade, n (%) | Grade 1, n (%) | Grade 2, n (%) | Grade 3, n (%) | Grade 4, n (%) |
|---|---|---|---|---|---|
| Chills | 17 (63) | 10 (37) | 7 (26) | — | — |
| Pain | 9 (33) | 4 (15) | 3 (11) | 2 (8) | — |
| Asthenia | 8 (30) | 5 (19) | 3 (11) | — | — |
| Gamma-glutamyl transpeptidase increased | 5 (19) | — | — | 4 (15) | 1 (4) |
| Oedema peripheral | 5 (19) | 2 (8) | 3 (11) | — | — |
| Fever | 5 (19) | 5 (19) | — | — | — |
| Hyperbilirubinaemia | 4 (15) | — | 1 (4) | 3 (11) | — |
| Blood pressure increased | 4 (15) | 3 (11) | 1 (4) | — | — |
| Ascites | 3 (11) | 1 (4) | — | 1 (4) | 1 (4) |
| Constipation | 3 (11) | 1 (4) | 2 (8) | — | — |
| Pruritus | 3 (11) | 2 (8) | 1 (4) | — | — |
| Aspartate aminotransferase increased | 2 (8) | — | — | 2 (8) | — |
| Diarrhoea | 2 (8) | 2 (8) | |||
| Dyspnoea | 2 (8) | 1 (4) | — | 1 (4) | — |
| Hyperkalaemia | 2 (8) | 1 (4) | 1 (4) | — | — |
| Hyperuricaemia | 2 (8) | 2 (8) | — | — | — |
| Insomnia | 2 (8) | 2 (8) | — | — | — |
| Nausea | 2 (8) | 1 (4) | 1 (4) | — | — |
| Performance status decreased | 2 (8) | — | — | 2 (8) | — |
| Anaemia | 1 (4) | — | — | — | 1 (4) |
| Anorexia | 1 (4) | 1 (4) | — | — | — |
| Blood uric acid increased | 1 (4) | 1 (4) | — | — | — |
| Bundle branch block left | 1 (4) | 1 (4) | — | — | — |
| Cholangitis | 1 (4) | — | 1 (4) | — | — |
| Confusional state | 1 (4) | — | — | 1 (4) | — |
| Depression | 1 (4) | — | 1 (4) | — | — |
| Dysgeusia | 1 (4) | 1 (4) | — | — | — |
| Dyspepsia | 1 (4) | — | 1 (4) | — | — |
| Encephalopathy | 1 (4) | — | 1 (4) | — | — |
| Extrasystoles | 1 (4) | 1 (4) | — | — | — |
| Flatulence | 1 (4) | 1 (4) | — | — | — |
| Haemoptysis | 1 (4) | — | 1 (4) | — | — |
| Haemorrhoids | 1 (4) | — | 1 (4) | — | — |
| Headache | 1 (4) | 1 (4) | — | — | — |
| Hepatic cirrhosis | 1 (4) | — | 1 (4) | — | — |
| Hepatic failure | 1 (4) | — | — | — | 1 (4) |
| Hyperammonaemia | 1 (4) | — | 1 (4) | — | — |
| Hyperammonaemic encephalopathy | 1 (4) | — | — | — | 1 (4) |
| Hypotension | 1 (4) | 1 (4) | — | — | — |
| Lymphopenia | 1 (4) | — | — | 1 (4) | — |
| Mucosal inflammation | 1 (4) | 1 (4) | — | — | — |
| Oesophageal varices haemorrhage | 1 (4) | 1 (4) | — | — | — |
| Pleural effusion | 1 (4) | 1 (4) | — | — | — |
| Pulmonary embolism | 1 (4) | — | — | — | 1 (4) |
| Rash | 1 (4) | — | 1 (4) | — | — |
| Sinus tachycardia | 1 (4) | 1 (4) | — | — | — |
| Syncope | 1 (4) | — | — | 1 (4) | — |
| Weight loss | 1 (4) | 1 (4) | — | — | — |