TABLE 2.
Serious Adverse events according to the Medical Dictionary for Regulatory Activities
| ER-tacrolimus | LCP-tacrolimus | ||||
|---|---|---|---|---|---|
| No. patients with event (n = 51) | No. events (n = 76) | No. patients with event (n = 53) | No. events (n = 84) | ||
| Serious adverse events | |||||
| Fevera | 11 (22%) | 23 (30.3%) | 8 (15.1%) | 14 (16.7%) | |
| Cholangitis and bile duct obstruction | 4 (7.8%) | 6 (7.9%) | 9 (17.0%) | 10 (11.9%) | |
| Infectionsb | 6 (11.7%) | 9 (11.8%) | 6 (11.3%) | 7 (8.3%) | |
| Liver transplant rejection | 5 (9.8%) | 5 (6.6%) | 6 (11.3%) | 7 (8.3%) | |
| Kidney injury/failure | 3 (5.9%) | 4 (5.3%) | 4 (7.5%) | 7 (8.3%) | |
| Hepatic artery thrombosis | — | — | 1 (1.9%) | 1 (1.2%) | |
| Other | 22 (43.1%) | 29 (38.2%) | 19 (35.8%) | 38 (45.2%) | |
| Outcome | |||||
| Death | 1 (2.0%) | — | 3 (5.7%) | — | |
| Resolved—no sequelae | 24 (47.1%) | 62 (81.6%) | 26.0 (49.1%) | 63 (75.0%) | |
| Resolved—with sequelae | 26 (51.0%) | 14 (18.4%) | 24 (45.3%) | 21 (25.0%) | |
aFever with an unspecified cause and no overlap with the SAEs for cholangitis or infections.
bInfections include every viral or bacterial infection occurred during the study period excluding cholangitis.
ER, extended-release; LCP, life cycle pharma; SAE, serious adverse event.