Table 5. Number of AEs occurring for the first time in single patients in the study group considered as a whole (Overall) and according to treatment arm.

Classification	Overall (n = 233)	AZA (n = 114)	MMF (n = 119)
SAEs	190	94	96
Acute rejection	105	51	54
Anemia	4	2	2
Cardiac and vascular	37	17	20
DGF	12	7	5
Disease recurrence	3	1	2
Endocrin	4	1	3
Graft dysfunction	22	9	13
Hematologic	5	4	1
Infectious	57	34	23
Leukopenia	8	3	5
Liver and gastrointestinal	38	17	21
Metabolic	4	2	2
Mood disorder	3	2	1
Neoplasm bladder	1	1	-
Neoplasm stomach	1	1	-
Neoplasm hematologic	3	2	1
Neoplasm kidney	8	6	2
Neoplasm prostate	1	1	-
Neoplasm skin	5	1	4
Neurologic	3	1	2
Ocular	1	1	-
Oral	5	2	3
Respiratory	28	18	10
Skin, subcutaneous, muscuskeletal, and trauma	8	5	3
Surgical	19	10	9
Thrombocytopenia	1	-	1
Urinary	1	1	-
Urological	42	21	21
Other	45	27	18
Non-SAEs	226	113	114
Acute rejection	9	7	2
Allergy	2	1	1
Anemia	100	55	45
Cardiac and vascular	98	48	50
Chronic rejection	51	20	31
DGF	19	10	9
Disease recurrence	3	3	-
Endocrin	41	19	22
Graft dysfunction	52	24	28
Graft failure	9	6	3
Hematologic	42	22	20
Infectious	164	80	84
Leukopenia	114	68**	46
Liver and gastrointestinal	120	59	61
Metabolic	197	97	100
Mood disorder	44	20	24
Neoplasm eye	1	-	1
Neoplasm skin	1	-	1
Neoplasm lung	2	1	1
Neoplasm thyroid	1	1	-
Neurologic	50	25	25
Ocular	31	17	14
Oral	24	10	14
Respiratory	65	34	31
Skin, subcutaneous, musculoskeletal, and trauma	74	38	36
Surgical	20	10	10
Thrombocytopenia	37	24*	13
Urinary	7	5	2
Urological	72	30	42
Other	152	78	74

Chi-squared or Fisher exact test vs MMF:

*p < 0.05,

**p < 0.01.

AE, adverse event; AZA, azathioprine; DGF, delayed graft function; MMF, mycophenolate mofetil; SAE, serious AE.