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