High level FK778 | Mid level FK778 | Low level FK778 | MMF | Total | |
---|---|---|---|---|---|
Intent to treat population (ITT) | 87 (100) | 92 (100) | 92 (100) | 93 (100) | 364 (100) |
Completed study | 50 (57.5) | 59 (64.1) | 71 (77.2) | 71 (76.3) | 251 (69) |
Reasons for study withdrawal: | |||||
Death | 0 | 1 (1.1) | 0 | 0 | 1 (0.3) |
Graft loss/retransplantation | 1 (1.1) | 1 (1.1) | 3 (3.3) | 2 (2.2) | 7 (1.9) |
Adverse event | 25 (28.7) | 19 (20.7) | 14 (15.2) | 12 (12.9) | 70 (19.2) |
Informed consent withdrawn | 4 (4.6) | 3 (3.3) | 2 (2.2) | 1 (1.1) | 10 (2.7) |
Prohibited medication | 3 (3.4) | 5 (5.4) | 0 | 1 (1.1) | 9 (2.5) |
Other | 4 (4.6) | 4 (4.3) | 2 (2.2) | 6 (6.5) | 16 (4.4) |