The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial

Table 3

Adverse events at year 3.

	Everolimus ()	CNI ()	value
Any adverse event, (%)	28 (96.6)	16 (57.1)	<0.001
Study drug discontinuation	10 (34.5)	0	<0.001
Infection	19 (65.5)	14 (50.0)	0.24
Infection with need for hospitalization	10 (34.5)	4 (14.3)	0.077
Neoplasm	2 (6.9)	3 (10.7)	0.67
Anemia	10 (34.5)	0	0.001
Leukopenia	6 (20.7)	1 (3.6)	0.10
Thrombocytopenia	1 (3.4)	0	1.0
Lower extremity edema	10 (34.5)	2 (7.1)	0.011
Skin rash	8 (27.6)	0	0.004
Oral aphtosis	5 (17.2)	0	0.052
Pulmonary toxicity	5 (17.2)	0	0.052
Diarrhea	7 (24.1)	2 (7.1)	0.14

CNI, calcineurin inhibitor.