Table 4

Most Frequently Reported Adverse Events
High level FK778 Mid level FK778 Low level FK77 MMF
N = 87 N = 92 N = 92 N = 93
Anemia 37 (42.5) 42 (45.7) 36 (39.1) 35 (37.6)
Leukopenia 7 (8) 11 (12) 6 (6.5) 13 (14)
Thrombocytopeniaa 9 (10.3) 4 (4.3) 11 (12) 2 (2.2)
Diarrhea 14 (16.1) 20 (21.7) 16 (17.4) 23 (24.7)
Constipation 15 (17.2) 8 (8.7) 7 (7.6) 17 (18.3)
Nausea 9 (10.3) 5 (5.4) 6 (6.5) 9 (9.7)
Vomiting 11 (12.6) 12 (13) 7 (7.6) 11 (11.8)
Peripheral edema 13 (14.9) 17 (18.5) 15 (16.3) 12 (12.9)
Chest painb 9 (10.3) 2 (2.2) 2 (2.2) 2 (2.2)
Bacterial urinary tract infection 19 (21.8) 29 (31.5) 28 (30.4) 27 (29)
Cytomegalovirus infection 4 (4.6) 5 (5.4) 9 (9.8) 10 (10.8)
Hypocalcaemia 13 (14.9) 13 (14.1) 12 (13) 9 (9.7)
Hyperglycemia 11 (12.6) 15 (16.3) 10 (10.9) 10 (10.8)
Hyperlipidemia 5 (5.7) 4 (4.3) 2 (2.2) 11 (11.8)
Hypokalemia 15 (17.2) 10 (10.9) 12 (13) 7 (7.5)
Hypoalbuminemiac 5 (5.7) 0 1 (1.1) 0
Hyperuricemia 9 (10.3) 21 (22.8) 20 (21.7) 12 (12.9)
Headache 11 (12.6) 11 (12) 9 (9.8) 4 (4.3)
Tremor 9 (10.3) 12 (13) 9 (9.8) 14 (15.1)
Insomnia 4 (4.6) 3 (3.3) 4 (4.3) 10 (10.8)
Hypertension 20 (23) 16 (17.4) 20 (21.7) 25 (26.9)

Data shown are for the ITT and presented as number (%). Most frequently reported adverse events occurring in ≥10% of patients in any group or occurring with a significant difference between groups. Excluded are renal- and allograft-related adverse events.

a P = 0.02, Fisher’s exact test: high level FK778 vs. MMF; b P = 0.03, Fisher’s exact test: high level FK778 vs. MMF; c P = 0.03, Fisher’s exact test: high level FK778 vs. MMF.

Wlodarczyk et al.

Wlodarczyk et al. BMC Nephrology 2012 13:68   doi:10.1186/1471-2369-13-68

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