Clinical Study

Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS

Table 3

Adverse events (AEs) occurring in ≥20% of patients in any group, or those AEs of particular interest.

EventsLow-dose Tac group 
(Group A), ( )
n (%)
Standard-dose Tac group
(Group B), ( )
n (%)

Any serious adverse event73 (48.3)67 (47.5)
Any infection90 (59.6)89 (63.1)
 Bacterial59 (39.1)65 (46.1)
 Viral33 (21.9)27 (19.1)
Any adverse event145 (96.0)138 (97.9)
 Diarrhea61 (40.4)61 (43.3)
 Nausea47 (31.1)47 (33.3)
 Constipation47 (31.1)46 (32.6)
 Urinary tract infection43 (28.5)44 (31.2)
 Anemia38 (25.2)46 (32.6)
 Procedural pain31 (20.5)33 (23.4)
 Edema peripheral34 (22.5)25 (17.7)
 Insomnia21 (13.9)32 (22.7)
 Tremor18 (11.9)29 (20.6)1

1 compared to Group A.