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) |