TABLE 4.

Safety profile of each tacrolimus formulation over the study period

	LCPT (N = 133)	PR‐Tac (N = 96)
Patients with AEs	82 (61.7%)	55 (57.3%)
Number of AEs	214	111
System organ class
Infections and infestations	52 (39.1%)	24 (25%)
Injury, poisoning and procedural complications	13 (9.8%)	11 (11.5%)
Neoplasms benign, malignant, and unspecified	2 (1.5%)	0
Cardiac disorders	1 (.8%)	1 (1.0%)
Congenital, familial, and genetic disorders	1 (.8%)	0
Blood and lymphatic system disorders a	1 (.8%)	2 (2.1%)
Metabolism and nutrition disorders	8 (6.0%)	6 (6.3%)
Immune system disorders	2 (1.5%)	2 (2.1%)
Nervous system disorders	42 (31.6%)	22 (22.9%)
Gastrointestinal disorders	16 (12%)	13 (13.5%)
General disorders and administration site conditions b	6 (4.5%)	1 (1.0%)
Musculoskeletal and connective tissue disorders	2 (1.5%)	0
Renal and urinary disorders	11 (8.3%)	3 (3.1%)
Vascular disorders	7 (5.3%)	3 (3.1%)
Patients with SAEs	36 (27.1%)	26 (27.1%)
Surgical complications c	5 (6.1%)	3 (5.5%)

Data are expressed as n (%) of patients with AEs relative to the safety population.

Abbreviations: AE, adverse event; SAE, serious adverse event.

^a LCPT: one leucopenia, PR‐Tac: One anemia, one polycythemia.

^b LCPT: one edema, three peripheral edema, three pyrexia; PR‐Tac: one peripheral edema.

^c % calculated over the number of patients with AEs.