A Randomized Multicenter Study Comparing a Tacrolimus-Based Protocol with and without Steroids in HCV-Positive Liver Allograft Recipients

Table 4

Incidence of adverse events occurring in ≥10% in either arm of full analysis set and with a significant difference between treatment arms, no. (%).

	TAC/DAC	TAC/STR
	𝑁=67	𝑁=68
Hepatitis C*	28 (41.8)	43 (63.2)
Hyperglycemia	9 (13.4)	13 (19.1)
Hyperkalemia	8 (11.9)	7 (10.3)
Anemia	22 (32.8)	21 (30.9)
Thrombocytopenia^†	19 (28.4)	6 (8.8)
Leukopenia	10 (14.9)	15 (22.1)
Pancytopenia	4 (6.0)	7 (10.3)
Renal failure	20 (29.9)	23 (33.8)
Acute renal failure	7 (10.4)	6 (8.8)
Diarrhea	9 (13.4)	14 (20.6)
Ascites	3 (4.5)	8 (11.8)
Hypertension	17 (25.4)	20 (29.4)
Hypotension	8 (11.9)	9 (13.2)
Pleural effusion	12 (17.9)	15 (22.1)
Headache	8 (11.9)	8 (11.8)
Tremor	9 (13.4)	6 (8.8)
Peripheral edema	7 (10.4)	10 (14.7)
Insomnia	7 (10.4)	5 (7.4)
Back pain	8 (11.9)	9 (13.2)
Pruritus	5 (7.5)	7 (10.3)

Not presented are adverse events related to the transplanted allograft or procedural complications.
* 𝑃=0.016; ^†𝑃=0.004 (Fisher’s exact test comparing the number of patients).