Table 3.
Adverse events related to the study drug occurring in ≥5% of patients (safety analysis set)
| SOC 1)
PT |
Safety analysis set (n = 32) |
|---|---|
| Any AE related to the study drug | 27 (84.4) |
| Gastrointestinal disorders | 15 (46.9) |
| Faeces pale | 6 (18.8) |
| Flatulence | 4 (12.5) |
| Abdominal distension | 3 (9.4) |
| Abdominal pain | 2 (6.3) |
| Constipation | 2 (6.3) |
| Diarrhoea | 2 (6.3) |
| Nausea | 2 (6.3) |
| General disorders and administration site conditions | 13 (40.6) |
| Injection site induration | 9 (28.1) |
| Injection site pruritus | 3 (9.4) |
| Malaise | 3 (9.4) |
| Injection site pain | 2 (6.3) |
| Pyrexia | 2 (6.3) |
| Metabolism and nutrition disorders | 7 (21.9) |
| Diabetes mellitus | 4 (12.5) |
| Hyperglycaemia | 2 (6.3) |
| Investigations | 4 (12.5) |
| Alanine aminotransferase increased | 3 (9.4) |
| Aspartate aminotransferase increased | 3 (9.4) |
SOC, system organ class; PT, preferred term
1)MedDRA version 16.0 was used for coding