Table 5.
Adverse Events Experienced by ≥20% of Patients, n (%)
| Preferred Term | LCPT (N = 29) | IR‐Tac (N = 29) | Overall (N = 58) |
|---|---|---|---|
| Any adverse events | 29 (100.0) | 29 (100.0) | 58 (100.0) |
| Diarrhea | 13 (44.8) | 11 (37.9) | 24 (41.4) |
| Edema, peripheral | 11 (37.9) | 10 (34.5) | 21 (36.2) |
| Constipation | 10 (34.5) | 7 (24.1) | 17 (29.3) |
| Headache | 10 (34.5) | 11 (37.9) | 21 (36.2) |
| Anemia | 9 (31.0) | 9 (31.0) | 18 (31.0) |
| Hepatitis C | 9 (31.0) | 8 (27.6) | 17 (29.3) |
| Nausea | 9 (31.0) | 13 (44.8) | 22 (37.9) |
| Hyperkalemia | 8 (27.6) | 4 (13.8) | 12 (20.7) |
| Hypokalemia | 8 (27.6) | 8 (27.6) | 16 (27.6) |
| Insomnia | 8 (27.6) | 6 (20.7) | 14 (24.1) |
| Tremor | 8 (27.6) | 10 (34.5) | 18 (31.0) |
| Fluid overload | 7 (24.1) | 5 (17.2) | 12 (20.7) |
| Liver transplant rejection | 7 (24.1) | 5 (17.2) | 12 (20.7) |
| Back pain | 6 (20.7) | 7 (24.1) | 13 (22.4) |
| Hypomagnesemia | 5 (17.2) | 10 (34.5) | 15 (25.9) |
IR‐Tac, twice‐daily immediate‐release tacrolimus capsules; LCPT, once‐daily extended‐release tablet formulation of tacrolimus.