TABLE 10.

Treatment-emergent adverse events (TEAE) in the safety population.

Subjects (%) [E]	LCPT (N = 200)	IR-Tac/PR-Tac (N = 201)	IR-Tac (N = 86)	PR-Tac (N = 115)
Any TEAE	195 (97.5) [1704]	192 (95.5) [1546]	82 (95.3) [637]	110 (95.7) [909]
Any treatment-emergent ADR	73 (36.5) [164]	77 (38.3) [141]	43 (50.0) [86]	34 (29.6) [55]
Any serious TEAE	99 (49.5) [185]	93 (46.3) [178]	40 (46.5) [68]	53 (46.1) [110]
Any serious TEADR	26 (13.0) [34]	23 (11.4) [28]	13 (15.1) [18]	10 (8.7) [10]
Any severe TEAE	48 (24.0) [92]	59 (29.4) [97]	29 (33.7) [46]	30 (26.1) [51]
Any TEAE leading to discontinuation	12 (6.0) [15]	16 (8.0) [16]	8 (9.3) [8]	8 (7.0) [8]
Any treatment-emergent ADR leading to discontinuation	3 (1.5) [3]	4 (2.0) [4]	2 (2.3) [2]	2 (1.7) [2]
Any AE leading to death	4 (2.0) [6]	4 (2.0) [4]	1 (1.2) [1]	3 (2.6) [3]

E, number of events; ADR, adverse drug reaction; AE, adverse event; IR-Tac, immediate release tacrolimus; LCPT, LCP tacrolimus; PR-Tac, prolonged release tacrolimus; TEAE, treatment emergent AE.