Patient characteristics
Eighty-six patients were screened for enrollment to this study. A total
of 24 patients were excluded at the screening because of the surplus ofCYP3A5 non-expressors (as stated above, the target size of this
group was defined as approximately 30). As another two patients were
excluded due to overdose of tacrolimus after the conversion to the
once-daily extended-release formulation, the study included 60 patients,
28 expressors and 32 non-expressors group among them (Figure 1). The
full analysis set (FAS) included all eligible patients who received ≥1
dose of once-daily extended release tacrolimus, with the patients
analyzed according to the treatment allocation. The per-protocol (PP)
set included all patients who completed the study without a major
protocol deviation.
The non-expressor group included a significantly higher proportion of
men than the expressor group (77.4% vs. 42.9%, P = 0.008). The two
study groups did not differ significantly in terms of other clinical
characteristics or in the time elapsed from the liver transplantation to
the study recruitment (Table 1).