Table 4:

Number of participants with AEs by system organ class (safety analysis set).

	Participants, n (%)
System organ class	Tacrolimus (N = 31)	Tacrolimus + SZC (N = 30)	Cyclosporin (N = 31)	Cyclosporin + SZC (N = 29)
Participants with any AE	7 (22.6)	13 (43.3)	8 (25.8)	7 (24.1)
Infections and infestations	0	2 (6.7)	1 (3.2)	0
Nervous system disorders	3 (9.7)	4 (13.3)	1 (3.2)	2 (6.9)
Eye disorders	1 (3.2)	0	1 (3.2)	0
Cardiac disorders	0	0	1 (3.2)	0
Respiratory, thoracic and mediastinal disorders	0	2 (6.7)	0	0
Gastrointestinal disorders	2 (6.5)	3 (10.0)	2 (6.5)	2 (6.9)
Musculoskeletal and connective tissue disorders	1 (3.2)	2 (6.7)	1 (3.2)	2 (6.9)
Renal and urinary disorders	0	0	1 (3.2)	0
General disorders and administration site conditions	1 (3.2)	0	0	2 (6.9)
Injury, poisoning and procedural complications	1 (3.2)	1 (3.3)	0	1 (3.4)

AE, adverse event.