Table 5.
Summary of hepatic AEs.
| Hepatic AEs, n (%)a,b | Total safety population, N = 1203 |
|---|---|
| Any hepatic AE | 222 (18) |
| Without pre-existing liver conditions | 211/1158 (18) |
| With pre-existing liver conditions | 11/45 (24) |
| Without potential hepatotoxic medication | 101/629 (16) |
| With potential hepatotoxic medication | 121/574 (21) |
| Serious hepatic AEs | 16 (1) |
| Drug-induced liver injury | 5 (<1) |
| Toxic hepatitis | 3 (<1) |
| ALT increase | 3 (<1) |
| AST increase | 3 (<1) |
| Liver injury | 2 (<1) |
| Chronic hepatitis | 1 (<1) |
| Hepatic necrosis | 1 (<1) |
| Hepatitis cholestatic | 1 (<1) |
| Jaundice | 1 (<1) |
| Blood bilirubin increase | 1 (<1) |
| Hepatic enzyme increase | 1 (<1) |
| Hepatic AEs by SOC | |
| Laboratory abnormalitiesc | 203 (17) |
| Hepatobiliary disorders | 36 (3) |
| Neoplasm – hemangiomas of the liver | 4 (<1) |
a
Defined using an SMQ for drug-related hepatic disorders, which is a sublevel of SMQ hepatic disorders and includes the preferred terms hepatobiliary disorders and investigations, among others.
b
Percentages out of total AEs reported.
c
Includes abnormalities of transaminases, bilirubin, liver function tests, hepatic enzyme, and gamma-glutamyl transferase.
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; SMQ, standardized Medical Dictionary for Regulatory Activities query; SOC, system organ class.