Comparable Renal Function at 6 Months with Tacrolimus Combined with Fixed-Dose Sirolimus or MMF: Results of a Randomized Multicenter Trial in Renal Transplantation

Table 4

Commonly ${\text{reported}}^{\text{a}}$ adverse events—number (%) of patients.

	Tacrolimus/Sirolimus $N=318$	Tacrolimus/MMF $N=316$
Adverse event
Metabolism or nutrition	167 (52.5)	156 (49.4)
Hyperglycemia	38 (11.9)	46 (14.6)
Diabetes mellitus	25 (7.9)	32 (10.1)
$\text{Hyperkalemi}{\text{a}}^{\text{b}}$	15 (4.7)	28 (8.9)
$\text{Hypercholesterolemi}{\text{a}}^{\text{b}}$	35 (11.0)	18 (5.7)
Infections	149 (46.9)	162 (51.3)
Urinary tract	83 (26.1)	83 (26.3)
$\text{Cytomegaloviru}{\text{s}}^{\text{c}}$	9 (2.8)	38 (12.0)
$\text{Nasopharyngiti}{\text{s}}^{\text{b}}$	7 (2.2)	19 (6.0)
Blood and lymphatic $\text{syste}{\text{m}}^{\text{b}}$	76 (23.9)	102 (32.6)
Anemia	52 (16.4)	68 (21.5)
$\text{Leukopeni}{\text{a}}^{\text{c}}$	5 (1.6)	27 (8.5)
Gastrointestinal disorders	83 (26.1)	90 (28.5)
$\text{Diarrhe}{\text{a}}^{\text{b}}$	38 (11.9)	57 (18.0)
Vascular disorders	74 (23.3)	54 (17.1)
General or site of drug administration	65 (20.4)	50 (15.8)
Peripheral $\text{edem}{\text{a}}^{\text{b}}$	22 (6.9)	10 (3.2)
Nervous system	44 (13.8)	45 (14.2)
Musculoskeletal	42 (13.2)	31 (9.8)
Serious Adverse Event
Infection	48 (15.1)	37 (11.7)
Cytomegalovirus $\text{infectio}{\text{n}}^{\text{c}}$	3 (0.9)	16 (5.1)
Vascular disorders	23 (7.2)	14 (4.4)
Gastrointestinal disorders	17 (5.3)	16 (5.1)
Cardiac $\text{disorder}{\text{s}}^{\text{b}}$	2 (0.6)	10 (3.2)

FAS
${}_{}{}^{\text{a}}\text{Listed}$ are the most common adverse events occurring in $\ge$10% of patients or with a significant difference between groups. Serious adverse events are listed if they occurred in $\ge$5% of patients. Reports of renal dysfunction/impairment, surgical complications, and abnormal laboratory values are not presented here as an adverse event.
${}_{}{}^{\text{b}}P<.05\text{.}$${}_{}{}^{\text{c}}P<.001$ (Fisher’s exact test for all comparisons).