Table 8

Adverse events to therapy

	Double blind study						Open label extension
	High trough (n = 21)		Low trough (n = 22)		Placebo (n = 20)		Tacrolimus (n = 61)
No of patients (%)	12 (57.1)*		11 (50.0)‡		7 (35.0)
	Related 10 (47.6)†	Unrelated 2 (9.5)	Related 5 (22.7)§	Unrelated 6 (27.3)	Related 3 (15.0)	Unrelated 4 (20.0)	Related 29 (47.5)
*Fisher’s exact test p = 0.215 versus placebo, p = 0.763 versus low trough.
†Fisher’s exact test p = 0.043 versus placebo, p = 0.116 versus low trough.
‡Fisher’s exact test p = 0.366 versus placebo.
§Fisher’s exact test p = 0.700 versus placebo.
Serious adverse events
Gastroenteritis	1 (4.8)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Sepsis	0 (0)	0 (0)	1 (4.5)	0 (0)	0 (0)	0 (0)	0 (0)
Adverse events occurring in >5% of patients in at least one of the treatment groups
Tremor finger	4 (19.0)	0 (0)	2 (9.1)	0 (0)	0 (0)	0 (0)	9 (14.8)
Sleepiness	2 (9.5)	0 (0)	0 (0)	0 (0)	1 (5.0)	0 (0)	0 (0)
Hot flush	2 (9.5)	0 (0)	1 (4.5)	0 (0)	0 (0)	0 (0)	1 (1.6)
Headache	0 (0)	0 (0)	0 (0)	0 (0)	1 (5.0)	1 (5.0)	5 (8.2)
Queasy	0 (0)	0 (0)	0 (0)	2 (9.1)	0 (0)	2 (10.0)	3 (4.9)
Stomach discomfort	1 (4.8)	1 (4.8)	0 (0)	0 (0)	0 (0)	1 (5.0)	1 (1.6)