Table 7.
Incidence of protocol violations by treatment arm1
| Outcome | TAC/SRL (n = 50) | TAC/MMF (n = 50) | CSA/SRL (n = 50) | Logrank Test P-Value2 |
|---|---|---|---|---|
| Protocol violation | 34 (71% ± 7%) | 9 (20% ± 6%) | 39 (83% ± 6%) | < 0.0001 |
| Ultimately switched to | ||||
| TAC/SRL | — | 1 | 2 (Protocol) | |
| TAC/MMF | 13 | — | 11 | |
| CSA/SRL | 0 | 0 | — | |
| TAC alone | 9 | 4 | 0 | |
| MMF/SRL | 10 | 4 | 13 | |
| TAC/SRL/MMF | 1 | 0 | 0 | |
| SRL alone | 1 | 0 | 0 | |
| CSA/MMF | 0 | 0 | 12 | |
| CSA alone | 0 | 0 | 1 | |
| Discontinued | ||||
| SRL or MMF | 22 (48% ± 8%) | 5 (11% ± 5%) | 24 (51% ± 7%) | 0.0001 |
| TAC or CSA | 12 (28% ± 7%) | 4 (9% ± 4%) | 28 (60% ± 7%) | <0.0001 |
| CNI therapy | 12 (28% ± 7%) | 4 (9% ± 4%) | 16 (36% ± 7%) | 0.02 |
SE, standard error; TAC, Tacrolimus; MMF, mycophenolate mofetil; CSA, cyclosporine microemulsion; SRL, Sirolimus; CI, calcineurin inhibitor.
1Number of patients with the event (actuarial estimate of failure at 96 mo post-transplant ± SE).
2The P-values listed in this column represent the results of the logrank test (with 2 degrees of freedom) for any differences among the 3 treatment groups' hazard rates failure. The logrank test comparing the hazard rate of developing a protocol violation between Groups TAC/SRL and CSA/SRL combined vs. Group TAC/MMF yielded P < 0.0001, and the logrank test comparing this hazard rate between Groups TAC/SRL and CSA/SRL yielded P = 0.12. The logrank test comparing the hazard rate of discontinuing Siro or MMF between Groups TAC/SRL and CSA/SRL combined vs. Group TAC/MMF yielded P < 0.0001, and the logrank test comparing this hazard rate between Groups TAC/SRL and CSA/SRL yielded P = 0.58. The logrank test comparing the hazard rate of discontinuing TAC or CSA between Groups TAC/SRL and TAC/MMF combined vs. Group CSA/SRL yielded P < 0.0001, and the logrank test comparing this hazard rate between Groups TAC/SRL and TAC/MMF yielded P = 0.04. The logrank test comparing the hazard rate of completely discontinuing CNI therapy between Groups TAC/SRL and CSA/SRL combined vs. Group TAC/MMF yielded P = 0.009, and the logrank test comparing this hazard rate between Groups TAC/SRL and CSA/SRL yielded P = 0.41.