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FIGURE 1 Trial profile. The safety population was defined as all randomly assigned patients who received at least one dose of study drug. All patients.

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Presentation on theme: "FIGURE 1 Trial profile. The safety population was defined as all randomly assigned patients who received at least one dose of study drug. All patients."— Presentation transcript:

1 FIGURE 1 Trial profile. The safety population was defined as all randomly assigned patients who received at least one dose of study drug. All patients who received at least one dose of study drug and underwent transplantation were included in the ITT population. KT, kidney transplantation. From: De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial Nephrol Dial Transplant. 2017;32(8): doi: /ndt/gfx093 Nephrol Dial Transplant | © The Author Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

2 FIGURE 2 Mean trough levels or doses of ER-TAC, SRL and MMF, according to study group (ITT population). (A) Tacrolimus trough levels in the ER-TAC plus SRL group and ER-TAC plus MMF group. (B) SRL trough levels in the ER-TAC plus SRL group. (C) MMF doses in ER-TAC plus MMF group. The grey zones represent the upper and lower limits of the respective target trough levels. The I bars represent the standard deviations. *P < 0.05 (calculated by between-group t-tests). From: De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial Nephrol Dial Transplant. 2017;32(8): doi: /ndt/gfx093 Nephrol Dial Transplant | © The Author Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

3 FIGURE 3 Differences in efficacy failure rates
FIGURE 3 Differences in efficacy failure rates. Differences in efficacy failure rates and the corresponding 95% CIs are shown. The difference represents the efficacy failure rate in the ER-TAC with MMF group minus the rate in the ER-TAC with SRL group. Efficacy failure is a composite of BPAR, graft loss, patient death and patient loss to follow-up. The predetermined non-inferiority margin δ was an absolute 15% difference (represented by the grey zone). From: De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial Nephrol Dial Transplant. 2017;32(8): doi: /ndt/gfx093 Nephrol Dial Transplant | © The Author Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

4 FIGURE 4 Graft renal function determined by eGFR (ITT and PP populations). The eGFR was determined using the modification of diet in renal disease formula. P-values were calculated by between-group t-tests. Black and grey bars represent the mean eGFR, and the I bars represent the standard deviations. From: De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial Nephrol Dial Transplant. 2017;32(8): doi: /ndt/gfx093 Nephrol Dial Transplant | © The Author Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

5 FIGURE 5 Cumulative probability of BPAR (A) and allograft survival (B) according to study group (ITT population). The number at risk at 12 months includes all patients who were not lost to follow-up and who had completed the 12-month visit. Data for patients with borderline acute rejection were excluded from the analysis of BPAR. Data for patients who died with a functioning graft were classified as graft loss for this analysis. From: De novo low-dose sirolimus versus mycophenolate mofetil in combination with extended-release tacrolimus in kidney transplant recipients: a multicentre, open-label, randomized, controlled, non-inferiority trial Nephrol Dial Transplant. 2017;32(8): doi: /ndt/gfx093 Nephrol Dial Transplant | © The Author Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.


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