Table 5.
All hepatobiliary treatment-emergent adverse events
| Hepatobiliary TEAEs by MedDRA SOC | Hepatobiliary TEAEs by MedDRA Preferred Term | Vidofludimus (N = 122) | Placebo (N = 119) | Total (N = 241) |
|---|---|---|---|---|
| Hepatobiliary disorders | 1 (0.8) | 3 (2.5) | 4 (1.7) | |
| Biliary colic | 0 (0.0) | 1 (0.8) | 1 (0.4) | |
| Hepatic pain | 0 (0.0) | 1 (0.8) | 1 (0.4) | |
| Hepatic steatosis | 0 (0.0) | 1 (0.8) | 1 (0.4) | |
| Hepatocellular injury | 1 (0.8) | 0 (0.0) | 1 (0.4) | |
| Investigations (hepatobiliary related) | 5 (4.1) | 4 (3.4) | 9 (3.7) | |
| Blood alkaline phosphatase increased | 4 (3.3) | 1 (0.8) | 5 (2.1) | |
| γ-Glutamyltransferase increased | 1 (0.8) | 1 (0.8) | 2 (0.8) | |
| Alanine aminotransferase increased | 0 (0.0) | 1 (0.8) | 1 (0.4) | |
| Hepatic enzyme increased | 0 (0.0) | 1 (0.8) | 1 (0.4) |
Data are expressed as n (%)
MedDRA Medical Dictionary for Regulatory Activities, N number of patients, SOC system organ class, TEAEs treatment-emergent adverse events