Trial Outcomes & Findings for Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients (NCT NCT00121810)

Last Updated: 2011-04-15

Results Overview

The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate. percent change= \[(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline\]\*100 percent.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

305 participants

Primary outcome timeframe

baseline to 12 months

Results posted on

2011-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Mycophenolate Mofetil + Sirolimus Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily	Mycophenolate Mofetil + Cyclosporine or Tacrolimus Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
Overall Study STARTED	151	154
Overall Study Safety Population	148	153
Overall Study Intent-to-Treat (ITT) Population	148	151
Overall Study COMPLETED	121	115
Overall Study NOT COMPLETED	30	39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mycophenolate Mofetil + Sirolimus n=148 Participants Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily	Mycophenolate Mofetil + Cyclosporine or Tacrolimus n=151 Participants Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol	Total n=299 Participants Total of all reporting groups
Age Continuous	48.7 years STANDARD_DEVIATION 12.90 • n=113 Participants	48.7 years STANDARD_DEVIATION 12.70 • n=163 Participants	48.7 years STANDARD_DEVIATION 12.80 • n=160 Participants
Sex: Female, Male Female	55 Participants n=113 Participants	55 Participants n=163 Participants	110 Participants n=160 Participants
Sex: Female, Male Male	93 Participants n=113 Participants	96 Participants n=163 Participants	189 Participants n=160 Participants

PRIMARY outcome

Timeframe: baseline to 12 months

Outcome measures

Outcome measures
Measure	Mycophenolate Mofetil + Sirolimus n=148 Participants Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily	Mycophenolate Mofetil + Cyclosporine or Tacrolimus n=151 Participants Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12 Baseline	59.5 percent change Standard Deviation 23.86	58.8 percent change Standard Deviation 26.06
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12 Mean Percent Change from Baseline at Month 12	24.4 percent change Standard Deviation 70.00	5.2 percent change Standard Deviation 56.33

SECONDARY outcome

Timeframe: Baseline to 24 months

A secondary efficacy endpoint was mean percent change in renal function from baseline to 24 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate. percent change= \[(Glomerular Filtration Rate at Month 24-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline\]\*100 percent.

Outcome measures

Outcome measures
Measure	Mycophenolate Mofetil + Sirolimus n=148 Participants Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily	Mycophenolate Mofetil + Cyclosporine or Tacrolimus n=151 Participants Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24 Baseline	59.5 percent change Standard Deviation 23.86	58.8 percent change Standard Deviation 26.06
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24 Percent Change from Baseline at Month 24	8.6 percent change Standard Deviation 55.32	3.4 percent change Standard Deviation 67.28

SECONDARY outcome

Timeframe: baseline, 6, 12, and 24 months

Population: Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.

Renal allograft function determined by mean percent change from baseline in serum creatinine by treatment group at 6, 12, and 24 months postrandomization. percent change= \[(serum creatinine at Month t-serum creatinine at baseline)/serum creatinine at baseline\]\*100 percent, where t=6, 12, and 24 months postrandomization.

Outcome measures

Outcome measures
Measure	Mycophenolate Mofetil + Sirolimus n=148 Participants Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily	Mycophenolate Mofetil + Cyclosporine or Tacrolimus n=151 Participants Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24 Baseline	121.1 percent change Standard Deviation 29.96	124.4 percent change Standard Deviation 37.87
Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24 Percent Change from Baseline at Month 6	-3.7 percent change Standard Deviation 18.78	6.6 percent change Standard Deviation 34.61
Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24 Percent Change from Baseline at Month 24	6.1 percent change Standard Deviation 59.84	30.8 percent change Standard Deviation 114.23
Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24 Percent Change from Baseline at Month 12	6.0 percent change Standard Deviation 57.81	20.4 percent change Standard Deviation 92.81

SECONDARY outcome

Timeframe: baseline 6, 12, and 24 months

Population: Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 129; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.

Renal allograft function determined by mean percent change from baseline in calculated creatinine clearance (Cockroft and Gault method) by treatment group at 6, 12, and 24 months postrandomization. percent change= \[(calculated creatinine clearance at Month t - calculated creatinine clearance at baseline)/calculated creatinine clearance at baseline\]\*100 percent, where t=6, 12, and 24 months postrandomization

Outcome measures

Outcome measures
Measure	Mycophenolate Mofetil + Sirolimus n=148 Participants Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily	Mycophenolate Mofetil + Cyclosporine or Tacrolimus n=151 Participants Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24 Baseline	59.7 percent change Standard Deviation 16.85	60.5 percent change Standard Deviation 19.97
Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24 Percent Change from Baseline at Month 6	7.0 percent change Standard Deviation 19.54	-1.7 percent change Standard Deviation 17.22
Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24 Percent Change from Baseline at Month 12	4.4 percent change Standard Deviation 24.38	-2.3 percent change Standard Deviation 25.09
Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24 Percent Change from Baseline at Month 24	4.7 percent change Standard Deviation 27.58	-4.2 percent change Standard Deviation 27.66

SECONDARY outcome

Timeframe: baseline, 6, 12, and 24 months

Population: Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 123, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.

Renal allograft function determined by mean percent change from baseline in calculated Glomerular Filtration Rate (Nankivell equation) by treatment group at 6, 12, and 24 months postrandomization. percent change= \[(calculated Glomerular Filtration Rate at Month t - calculated Glomerular Filtration Rate at baseline)/calculated Glomerular Filtration Rate at baseline\]\*100 percent, where t=6, 12, and 24 months postrandomization.

Outcome measures

Outcome measures
Measure	Mycophenolate Mofetil + Sirolimus n=148 Participants Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily	Mycophenolate Mofetil + Cyclosporine or Tacrolimus n=151 Participants Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation) Baseline	71.3 percent change Standard Deviation 13.82	72.7 percent change Standard Deviation 16.2
Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation) Percent Change from Baseline at Month 6	8.3 percent change Standard Deviation 19.57	-0.5 percent change Standard Deviation 15.98
Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation) Percent Change from Baseline at Month 12	5.2 percent change Standard Deviation 25.33	-0.9 percent change Standard Deviation 23.42
Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation) Percent Change from Baseline at Month 24	6.5 percent change Standard Deviation 28.43	-1.8 percent change Standard Deviation 27.31

Adverse Events

Mycophenolate Mofetil + Sirolimus

Serious events: 60 serious events

Other events: 147 other events

Deaths: 0 deaths

Mycophenolate Mofetil + Cyclosporine or Tacrolimus

Serious events: 64 serious events

Other events: 148 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Mycophenolate Mofetil + Sirolimus n=148 participants at risk Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily	Mycophenolate Mofetil + Cyclosporine or Tacrolimus n=153 participants at risk Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
Infections and infestations Pneumonia	9.5% 14/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	5.9% 9/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Urinary Tract Infection	3.4% 5/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	5.2% 8/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Pyelonephritis	2.7% 4/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	2.0% 3/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Cellulitis	2.7% 4/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Urosepsis	2.0% 3/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	1.3% 2/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Gastroenteritis	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Gangrene	1.4% 2/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Gastroenteritis Viral	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	1.3% 2/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Osteomyelitis	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Sepsis	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Staphylococcal Infection	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	1.3% 2/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Viral Infection	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Appendicitis	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Bacteraemia	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	1.3% 2/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Bacterial Diarrhoea	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations BK Virus Infection	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Bronchitis	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Catheter Related Infection	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Coccidioidomycosis	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Diarrhoea Infectious	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Ear Infection	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Epstein-Barr Virus Infection	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Escherichia Bacteraemia	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Gastroenteritis Clostridial	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Infected Skin Ulcer	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Liver Abscess	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Lung Abscess	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Nocardiosis	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Perinephric Abscess	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Pharyngitis	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Sinusitis	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Staphylococcal Abscess	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Wound Infection	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
General disorders Chest Pain	2.7% 4/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	2.0% 3/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
General disorders Pyrexia	2.7% 4/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	2.0% 3/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
General disorders Asthenia	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
General disorders Chest Discomfort	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
General disorders Hyperthermia	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.65% 1/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
General disorders Impaired Healing	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
General disorders Oedema Peripheral	0.68% 1/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.

Other adverse events
Measure	Mycophenolate Mofetil + Sirolimus n=148 participants at risk Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily	Mycophenolate Mofetil + Cyclosporine or Tacrolimus n=153 participants at risk Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
Infections and infestations Urinary Tract Infection	14.9% 22/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	21.6% 33/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Upper Respiratory Tract Infection	14.2% 21/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	12.4% 19/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Nasopharyngitis	8.8% 13/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	10.5% 16/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations Pneumonia	9.5% 14/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	7.8% 12/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Infections and infestations BK Virus Infection	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	5.9% 9/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Gastrointestinal disorders Diarrhoea	34.5% 51/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	32.7% 50/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Gastrointestinal disorders Nausea	11.5% 17/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	6.5% 10/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Gastrointestinal disorders Vomiting	9.5% 14/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	7.8% 12/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Gastrointestinal disorders Abdominal Pain	6.1% 9/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	9.2% 14/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Gastrointestinal disorders Mouth Ulceration	14.2% 21/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	0.00% 0/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	5.2% 8/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Metabolism and nutrition disorders Hyperlipidaemia	29.7% 44/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	13.1% 20/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Metabolism and nutrition disorders Hypokalaemia	13.5% 20/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	3.9% 6/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Metabolism and nutrition disorders Hyperglycaemia	5.4% 8/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	5.9% 9/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Metabolism and nutrition disorders Hypercholesterolaemia	6.1% 9/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	3.9% 6/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Metabolism and nutrition disorders Hyperkalaemia	1.4% 2/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	5.9% 9/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Metabolism and nutrition disorders Hypoglycaemia	5.4% 8/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	2.0% 3/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Metabolism and nutrition disorders Hypomagnesaemia	2.0% 3/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	5.2% 8/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
General disorders Oedema Peripheral	28.4% 42/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	13.1% 20/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
General disorders Fatigue	10.1% 15/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	7.8% 12/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
General disorders Pyrexia	10.1% 15/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	7.8% 12/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
General disorders Oedema	6.8% 10/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	3.3% 5/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 11/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	7.2% 11/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Musculoskeletal and connective tissue disorders Back Pain	10.1% 15/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	3.9% 6/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Musculoskeletal and connective tissue disorders Pain in Extremity	8.1% 12/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	5.9% 9/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Musculoskeletal and connective tissue disorders Osteopenia	5.4% 8/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	4.6% 7/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Musculoskeletal and connective tissue disorders Muscle Spasms	2.7% 4/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	5.2% 8/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Musculoskeletal and connective tissue disorders Osteoporosis	6.1% 9/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	1.3% 2/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Investigations Blood Creatinine Increased	9.5% 14/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	20.3% 31/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Investigations Weight Increased	4.7% 7/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	5.2% 8/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Blood and lymphatic system disorders Leukopenia	24.3% 36/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	19.0% 29/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Blood and lymphatic system disorders Anaemia	16.9% 25/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	11.1% 17/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Blood and lymphatic system disorders Polycythaemia	1.4% 2/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	5.9% 9/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Blood and lymphatic system disorders Neutropenia	1.4% 2/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	4.6% 7/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Skin and subcutaneous tissue disorders Acne	8.1% 12/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	4.6% 7/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Skin and subcutaneous tissue disorders Rash	5.4% 8/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	4.6% 7/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Skin and subcutaneous tissue disorders Skin Ulcer	5.4% 8/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	2.0% 3/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Respiratory, thoracic and mediastinal disorders Cough	10.8% 16/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	10.5% 16/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	5.4% 8/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	4.6% 7/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.7% 7/148 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.	2.6% 4/153 Safety population. Three patients (38957/143, 38960/077, 38960/082) who were randomized to the Mycophenolate mofetil + sirolimus group did not switch to sirolimus after randomization and were included in the Mycophenolate Mofetil + cyclosporine or tacrolimus group for safety. These patients were excluded from the ITT population.