Trial Outcomes & Findings for Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients (NCT NCT00311311)

NCT ID: NCT00311311

Last Updated: 2013-09-23

Results Overview

Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus \[-\] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 72 participants
• Primary outcome timeframe: Pre-conversion baseline and 12 months post-transplant
• Results posted on: 2013-09-23

Participant Flow

Participant milestones

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone Participant received tacrolimus (TAC), (target trough level of 3-10 nanogram per milliliter \[ng/mL\] by 3-6 months post-transplant) plus mycophenolate mofetil (MMF) (greater than or equal to \[\>=\] 500 milligram per day \[mg/day\]) or mycophenolate sodium (MPS) (\>= 360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or azathioprine (AZA) (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to cyclosporine (CsA) (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Overall Study STARTED	37	35
Overall Study COMPLETED	29	26
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone Participant received tacrolimus (TAC), (target trough level of 3-10 nanogram per milliliter \[ng/mL\] by 3-6 months post-transplant) plus mycophenolate mofetil (MMF) (greater than or equal to \[\>=\] 500 milligram per day \[mg/day\]) or mycophenolate sodium (MPS) (\>= 360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or azathioprine (AZA) (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to cyclosporine (CsA) (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Overall Study Adverse Event	3	2
Overall Study Withdrawal by Subject	1	1
Overall Study Noncompliance	0	1
Overall Study Study Termination by Sponsor	3	4
Overall Study Death	1	0
Overall Study Lack of ancillary assistance	0	1

Baseline Characteristics

Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients

Baseline characteristics by cohort

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=37 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=35 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.	Total n=72 Participants Total of all reporting groups
Age Continuous	55.8 years STANDARD_DEVIATION 11.11 • n=5 Participants	55.5 years STANDARD_DEVIATION 11.08 • n=7 Participants	55.7 years STANDARD_DEVIATION 11.02 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-conversion baseline and 12 months post-transplant

Population: On-Therapy Population: includes all intent-to-treat (ITT) subjects who also remained on assigned therapy until 12 months post-transplant for the primary endpoint, or until 36 months post-transplant for the cardiovascular and safety endpoints; N=number of evaluable participants for the outcome measure at 12 months post-transplant

Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=18 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=20 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant	-49.31 millimeter cube/year (mmˆ3/year) Standard Deviation 125.038	0.66 millimeter cube/year (mmˆ3/year) Standard Deviation 23.103

PRIMARY outcome

Timeframe: Pre-conversion baseline

Population: On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline

TPV is the sum of the assessment in left and right distal common carotid arteries.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=19 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=21 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
TPV at Pre-conversion Baseline	68.68 mmˆ3 Standard Deviation 116.574	48.57 mmˆ3 Standard Deviation 72.207

SECONDARY outcome

Timeframe: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Within-subject annual change rate in CIMT as determined by ultrasound. Mean CIMT=average of left CIMT and right CIMT. Annual CIMT Change Rate (mm/year) = (CIMT at Month x Post-transplant Visit - CIMT at Conversion Baseline) / Imaging interval in years.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant Annual Change Rate at 12 months (n=16,28)	0.048 millimeter/year (mm/year) Standard Deviation 0.0977	0.012 millimeter/year (mm/year) Standard Deviation 0.0732
Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant Annual Change Rate at 18 months (n=15,26)	0.041 millimeter/year (mm/year) Standard Deviation 0.0641	-0.0002 millimeter/year (mm/year) Standard Deviation 0.0543
Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant Annual Change Rate at 24 months (n=15,23)	0.023 millimeter/year (mm/year) Standard Deviation 0.0614	0.015 millimeter/year (mm/year) Standard Deviation 0.0453
Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant Annual Change Rate at 36 months (n=8,13)	0.028 millimeter/year (mm/year) Standard Deviation 0.0381	-0.007 millimeter/year (mm/year) Standard Deviation 0.0460

SECONDARY outcome

Timeframe: Pre-conversion baseline

Population: On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline

Mean CIMT=average of left CIMT and right CIMT.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=17 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=29 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
CIMT at Pre-conversion Baseline	0.735 mm Standard Deviation 0.1502	0.773 mm Standard Deviation 0.1391

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, and 24 months post-transplant

Population: Evaluation of carotid plaque roughness at pre-conversion baseline, and at 12 and 24 months post-transplant was planned in the study design, however during the study conduct, it was removed as a cardiovascular endpoint since it was not validated.

Carotid plaque roughness as determined by ultrasound. Change equals (=) value at post-transplant month x minus (-) pre-conversion baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglyceride (Tg) blood concentrations. Higher levels of TC, LDL and Tg are less desirable. Lower levels of HDL are less desirable. Change for each parameter = value at 12, 18, 24 and 36 months post-transplant - value at pre-conversion baseline.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in HDL 18 Months post-transplant (n=21,29)	0.106 millimole/liter (mmol/L) Standard Deviation 0.2824	-0.030 millimole/liter (mmol/L) Standard Deviation 0.3601
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in TC 12 Months post-transplant (n=23,30)	0.510 millimole/liter (mmol/L) Standard Deviation 1.0743	-0.164 millimole/liter (mmol/L) Standard Deviation 0.8271
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in LDL 12 Months post-transplant (n=21,30)	0.277 millimole/liter (mmol/L) Standard Deviation 0.8282	-0.056 millimole/liter (mmol/L) Standard Deviation 0.5612
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in HDL 12 Months post-transplant (n=23,30)	0.059 millimole/liter (mmol/L) Standard Deviation 0.3009	-0.053 millimole/liter (mmol/L) Standard Deviation 0.4417
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in Tg 12 Months post-transplant (n=23,30)	0.617 millimole/liter (mmol/L) Standard Deviation 1.1135	-0.117 millimole/liter (mmol/L) Standard Deviation 0.6088
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in TC 18 Months post-transplant (n=21,29)	0.361 millimole/liter (mmol/L) Standard Deviation 1.0704	0.082 millimole/liter (mmol/L) Standard Deviation 1.1427
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in LDL 18 Months post-transplant (n=20,29)	0.222 millimole/liter (mmol/L) Standard Deviation 0.9283	0.138 millimole/liter (mmol/L) Standard Deviation 0.8600
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in Tg 18 Months post-transplant (n=21,29)	0.359 millimole/liter (mmol/L) Standard Deviation 0.9941	-0.057 millimole/liter (mmol/L) Standard Deviation 0.8699
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in TC 24 Months post-transplant (n=19,27)	0.240 millimole/liter (mmol/L) Standard Deviation 1.1375	-0.008 millimole/liter (mmol/L) Standard Deviation 1.0813
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in LDL 24 Months post-transplant (n=16,27)	0.067 millimole/liter (mmol/L) Standard Deviation 0.9493	0.054 millimole/liter (mmol/L) Standard Deviation 0.8250
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in HDL 24 Months post-transplant (n=19,27)	0.067 millimole/liter (mmol/L) Standard Deviation 0.2485	-0.019 millimole/liter (mmol/L) Standard Deviation 0.3552
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in Tg 24 Months post-transplant (n=19,27)	0.547 millimole/liter (mmol/L) Standard Deviation 1.4083	-0.088 millimole/liter (mmol/L) Standard Deviation 0.8131
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in TC 36 Months post-transplant (n=15,21)	0.386 millimole/liter (mmol/L) Standard Deviation 0.4841	-0.323 millimole/liter (mmol/L) Standard Deviation 1.0652
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in LDL 36 Months post-transplant (n=13,21)	0.027 millimole/liter (mmol/L) Standard Deviation 0.5619	-0.257 millimole/liter (mmol/L) Standard Deviation 0.8248
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in HDL 36 Months post-transplant (n=15,21)	0.098 millimole/liter (mmol/L) Standard Deviation 0.2141	0.111 millimole/liter (mmol/L) Standard Deviation 0.3042
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant Change in Tg 36 Months post-transplant (n=15,21)	0.527 millimole/liter (mmol/L) Standard Deviation 0.9968	-0.385 millimole/liter (mmol/L) Standard Deviation 0.7824

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Fasting plasma glucose. Change = value at month x post-transplant - pre-conversion baseline values.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant Change at 12 Months post-transplant (n=23,33)	0.606 mmol/L Standard Deviation 2.9461	-0.083 mmol/L Standard Deviation 1.7377
Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant Change at 24 Months post-transplant (n=19,31)	0.832 mmol/L Standard Deviation 2.2068	-0.076 mmol/L Standard Deviation 2.3982
Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant Change at 36 Months post-transplant (n=14,22)	0.686 mmol/L Standard Deviation 2.3559	-0.214 mmol/L Standard Deviation 1.8239

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Fasting insulin. Change = value at month x post-transplant - pre-conversion baseline.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant Change at 12 Months post-transplant (n=16,23)	-4.549 picomole/liter (pmol/L) Standard Deviation 69.2139	17.953 picomole/liter (pmol/L) Standard Deviation 151.0513
Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant Change at 24 Months post-transplant (n=13,23)	-6.120 picomole/liter (pmol/L) Standard Deviation 124.5500	32.180 picomole/liter (pmol/L) Standard Deviation 168.4674
Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant Change at 36 Months post-transplant (n=10,14)	-22.759 picomole/liter (pmol/L) Standard Deviation 79.8717	-2.731 picomole/liter (pmol/L) Standard Deviation 37.6576

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at the specific time point

HbA1C, change = value at month x post-transplant - pre-conversion baseline.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant Change at 12 Months post-transplant (n=23,26)	0.008 percentage of glucose Standard Deviation 0.0176	0.001 percentage of glucose Standard Deviation 0.0175
Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant Change at 24 Months post-transplant (n=17,25)	0.009 percentage of glucose Standard Deviation 0.0161	0.006 percentage of glucose Standard Deviation 0.0200
Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant Change at 36 Months post-transplant (n=14,16)	0.012 percentage of glucose Standard Deviation 0.0208	-0.001 percentage of glucose Standard Deviation 0.0232

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Adiponectin is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates less risk. Change = month x post-transplant values - pre-conversion baseline values.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant Change at 12 Months post-transplant (n=23,33)	5.352 microgram per milliliter (µg/mL) Standard Deviation 5.8935	-2.205 microgram per milliliter (µg/mL) Standard Deviation 8.2503
Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant Change at 24 Months post-transplant (n=18,31)	2.244 microgram per milliliter (µg/mL) Standard Deviation 7.3628	-0.267 microgram per milliliter (µg/mL) Standard Deviation 6.6144
Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant Change at 36 Months post-transplant (n=15,22)	1.487 microgram per milliliter (µg/mL) Standard Deviation 6.0933	-1.413 microgram per milliliter (µg/mL) Standard Deviation 8.8053

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

hsCRP is a biomarker of cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant. Change at 12 Months post-transplant (n=23,33)	1.611 mg/L Standard Deviation 9.7219	1.379 mg/L Standard Deviation 6.7680
Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant. Change at 24 Months post-transplant (n=18,31)	-0.563 mg/L Standard Deviation 4.8347	1.723 mg/L Standard Deviation 7.6259
Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant. Change at 36 Months post-transplant (n=15,22)	0.336 mg/L Standard Deviation 11.3537	3.164 mg/L Standard Deviation 12.5660

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

TNF-alpha is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant Change at 12 Months post-transplant (n=23,32)	0.991 pg/mL Standard Deviation 6.3462	0.000 pg/mL Standard Deviation 0.0000
Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant Change at 24 Months post-transplant (n=18,30)	-0.367 pg/mL Standard Deviation 1.5580	1.894 pg/mL Standard Deviation 10.3720
Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant Change at 36 Months post-transplant (n=15,22)	-0.441 pg/mL Standard Deviation 1.7067	0.000 pg/mL Standard Deviation 0.0000

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point

Endothelin-1 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates greater risk. Change = month x post-transplant values - pre-conversion baseline values.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant Change at 12 Months post-transplant (n=22,30)	0.294 pg/mL Standard Deviation 0.4975	0.028 pg/mL Standard Deviation 0.4020
Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant Change at 24 Months post-transplant (n=18,30)	0.426 pg/mL Standard Deviation 0.5376	0.138 pg/mL Standard Deviation 0.8367
Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant Change at 36 Months post-transplant (n=14,22)	0.411 pg/mL Standard Deviation 0.7316	-0.104 pg/mL Standard Deviation 0.7767

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point

IL-6 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant Change at 36 Months post-transplant (n=15,22)	-0.800 pg/mL Standard Deviation 3.8270	0.164 pg/mL Standard Deviation 6.4529
Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant Change at 12 Months post-transplant (n=23,32)	-0.239 pg/mL Standard Deviation 3.6820	0.463 pg/mL Standard Deviation 3.8100
Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant Change at 24 Months post-transplant (n=18,29)	0.128 pg/mL Standard Deviation 6.9315	0.783 pg/mL Standard Deviation 4.7295

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point

Homocysteine is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant Change at 12 Months post-transplant (n=23,33)	1.278 micromole/liter (µmol/L) Standard Deviation 3.5572	0.530 micromole/liter (µmol/L) Standard Deviation 4.6244
Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant Change at 24 Months post-transplant (n=19,31)	1.316 micromole/liter (µmol/L) Standard Deviation 4.5373	2.158 micromole/liter (µmol/L) Standard Deviation 5.8978
Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant Change at 36 Months post-transplant (n=15,22)	1.087 micromole/liter (µmol/L) Standard Deviation 4.6641	2.459 micromole/liter (µmol/L) Standard Deviation 5.3116

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Lipoprotein(a) is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant Change at 12 Months post-transplant (n=23,30)	13.496 milligram per deciliter (mg/dL) Standard Deviation 23.3557	-11.680 milligram per deciliter (mg/dL) Standard Deviation 77.1386
Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant Change at 24 Months post-transplant (n=18,26)	12.517 milligram per deciliter (mg/dL) Standard Deviation 36.8868	6.073 milligram per deciliter (mg/dL) Standard Deviation 31.5608
Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant Change at 36 Months post-transplant (n=13,17)	11.885 milligram per deciliter (mg/dL) Standard Deviation 49.4868	6.547 milligram per deciliter (mg/dL) Standard Deviation 22.0615

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Fibrinogen is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant Change at 12 Months post-transplant (n=22,31)	0.62 gram per liter (g/L) Standard Deviation 0.778	0.20 gram per liter (g/L) Standard Deviation 0.769
Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant Change at 24 Months post-transplant (n=19,29)	0.45 gram per liter (g/L) Standard Deviation 0.777	0.33 gram per liter (g/L) Standard Deviation 0.741
Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant Change at 36 Months post-transplant (n=14,20)	0.40 gram per liter (g/L) Standard Deviation 0.557	0.21 gram per liter (g/L) Standard Deviation 0.740

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points

Vitamin B12 is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant Change at 12 Months post-transplant (n=21,33)	-10.21 pmol/L Standard Deviation 161.662	-11.38 pmol/L Standard Deviation 146.530
Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant Change at 24 Months post-transplant (n=19,29)	-36.23 pmol/L Standard Deviation 88.910	-27.46 pmol/L Standard Deviation 134.595
Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant Change at 36 Months post-transplant (n=14,21)	-40.00 pmol/L Standard Deviation 135.353	-46.39 pmol/L Standard Deviation 183.283

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points

Uric Acid is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant Change at 24 Months post-transplant (n=19,31)	-29.02 µmol/L Standard Deviation 93.350	3.89 µmol/L Standard Deviation 85.439
Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant Change at 36 Months post-transplant (n=15,22)	-19.03 µmol/L Standard Deviation 83.162	-0.58 µmol/L Standard Deviation 99.831
Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant Change at 12 Months post-transplant (n=23,33)	-51.53 µmol/L Standard Deviation 68.987	11.10 µmol/L Standard Deviation 89.871

SECONDARY outcome

Timeframe: Pre-conversion baseline, 12, 24 and 36 months post-transplant

Population: Two types of folate tests were used: serum folate and red blood cell (RBC) folate. The tests were not consistent across sites. Therefore, the evaluation was not analyzed.

Folate is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point

Participants who reported "yes" for taking lipid lowering therapies as concomitant medication.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Number of Participants Who Used Lipid Lowering Therapies From consent to conversion	13 participants	24 participants
Number of Participants Who Used Lipid Lowering Therapies From conversion to Month 12	22 participants	29 participants
Number of Participants Who Used Lipid Lowering Therapies From Months 12 to Month 24	23 participants	28 participants
Number of Participants Who Used Lipid Lowering Therapies From Months 24 to Month 36	18 participants	27 participants

SECONDARY outcome

Timeframe: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point

Participants who reported "yes" for taking anti-hypertensive medications as concomitant medication.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Number of Participants Who Used Anti-hypertensive Medications From consent to conversion	19 participants	30 participants
Number of Participants Who Used Anti-hypertensive Medications From conversion to Month 12	21 participants	30 participants
Number of Participants Who Used Anti-hypertensive Medications From Months 12 to Month 24	21 participants	30 participants
Number of Participants Who Used Anti-hypertensive Medications From Months 24 to Month 36	18 participants	28 participants

SECONDARY outcome

Timeframe: Pre-conversion baseline, and 18, 24 and 36 months post-transplant

Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point

Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 18, 24 and 36 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 18, 24 and 36 post-transplant minus [-] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.

Outcome measures

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=23 Participants Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=33 Participants Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant Month 24 post-transplant (n=11,14)	25.28 mmˆ3/year Standard Deviation 67.393	9.10 mmˆ3/year Standard Deviation 39.707
Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant Month 36 post-transplant (n=7,11)	6.62 mmˆ3/year Standard Deviation 66.240	8.98 mmˆ3/year Standard Deviation 25.505
Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant Month 18 post-transplant (n=12,12)	17.15 mmˆ3/year Standard Deviation 92.151	19.71 mmˆ3/year Standard Deviation 44.734

Adverse Events

Tacrolimus Then Sirolimus With Mycophenolate/Prednisone

Serious events: 17 serious events

Other events: 36 other events

Deaths: 0 deaths

Tacrolimus With Mycophenolate/Prednisone

Serious events: 21 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=37 participants at risk Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=35 participants at risk Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
General disorders CARCINOMA	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders CELLULITIS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders CHEST PAIN	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders FEVER	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders HERNIA	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders IMMUNE SYSTEM DISORDER	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders INFECTION	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders SEPSIS	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders VIRAL INFECTION	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders ARTERIOSCLEROSIS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders CORONARY ARTERY DISORDER	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders EMBOLUS	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders MYOCARDIAL INFARCT	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders PERIPHERAL VASCULAR DISORDER	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders THROMBOPHLEBITIS	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders THROMBOSIS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders ESOPHAGITIS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders GASTROINTESTINAL HEMORRHAGE	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders HEPATITIS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders NAUSEA	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders VOMITING	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders LEUKOPENIA	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders HYPONATREMIA	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders BONE DISORDER	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders BONE NECROSIS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders CEREBRAL ISCHEMIA	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders NEUROPATHY	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders PARAPLEGIA	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders HEMOPTYSIS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders PHARYNGITIS	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders PNEUMONIA	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders SINUSITIS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders ACUTE KIDNEY FAILURE	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders KIDNEY FAILURE	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders KIDNEY FUNCTION ABNORMAL	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders PROSTATIC CARCINOMA	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders PYELONEPHRITIS	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders URINARY TRACT INFECTION	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders ACCIDENTAL INJURY	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders INFECTION BACTERIAL	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders VASCULAR ANOMALY	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders HYPOCALCEMIA	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders ARTHROSIS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders OSTEOMYELITIS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders SKIN CARCINOMA	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders ANGINA PECTORIS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders Congestive Heart Failure	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Tacrolimus Then Sirolimus With Mycophenolate/Prednisone n=37 participants at risk Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.	Tacrolimus With Mycophenolate/Prednisone n=35 participants at risk Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator.
Gastrointestinal disorders GASTROINTESTINAL DISORDER	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Endocrine disorders PARATHYROID DISORDER	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders ABDOMINAL PAIN	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders ACCIDENTAL INJURY	24.3% 9/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	14.3% 5/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders ASTHENIA	13.5% 5/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders BACK PAIN	10.8% 4/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	20.0% 7/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders CHEST PAIN	13.5% 5/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders FLU SYNDROME	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.4% 4/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders HEADACHE	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders IMMUNE SYSTEM DISORDER	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders INFECTION	24.3% 9/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	20.0% 7/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders PAIN	18.9% 7/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	20.0% 7/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders VIRAL INFECTION	10.8% 4/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	20.0% 7/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders ARTERIOSCLEROSIS	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders HYPERTENSION	13.5% 5/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders HYPOTENSION	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders APHTHOUS STOMATITIS	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders CONSTIPATION	16.2% 6/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders DIARRHEA	13.5% 5/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	14.3% 5/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders FLATULENCE	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders GASTROENTERITIS	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders NAUSEA	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders STOMATITIS	10.8% 4/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders VOMITING	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders ANEMIA	10.8% 4/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	20.0% 7/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders LEUKOPENIA	16.2% 6/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders AVITAMINOSIS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders CREATININE INCREASED	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	20.0% 7/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders DIABETES MELLITUS	13.5% 5/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders EDEMA	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders GLUCOSE TOLERANCE DECREASED	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders HYPERCALCEMIA	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	14.3% 5/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders HYPERCHOLESTEREMIA	24.3% 9/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders HYPERLIPEMIA	37.8% 14/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	14.3% 5/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders PERIPHERAL EDEMA	35.1% 13/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	17.1% 6/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders WEIGHT GAIN	13.5% 5/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	17.1% 6/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders ARTHRALGIA	18.9% 7/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.4% 4/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders ARTHROSIS	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders BONE DISORDER	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders JOINT DISORDER	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders INSOMNIA	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders PARESTHESIA	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders COUGH INCREASED	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders DYSPNEA	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders PHARYNGITIS	18.9% 7/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	17.1% 6/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders RHINITIS	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.4% 4/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders ACNE	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders DRY SKIN	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders HERPES ZOSTER	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders PRURITUS	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders RASH	18.9% 7/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders SKIN BENIGN NEOPLASM	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.4% 4/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders SKIN DISORDER	10.8% 4/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders SKIN HYPERTROPHY	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders SWEATING	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Eye disorders CONJUNCTIVITIS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders ALBUMINURIA	24.3% 9/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders HEMATURIA	13.5% 5/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.4% 4/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders URINARY TRACT INFECTION	10.8% 4/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	14.3% 5/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders FEVER	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders LAB TEST ABNORMAL	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Cardiac disorders DEEP THROMBOPHLEBITIS	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders ANOREXIA	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders DYSPEPSIA	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders POLYCYTHEMIA	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders HYPERKALEMIA	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	8.6% 3/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders HYPOKALEMIA	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders MYALGIA	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders ANXIETY	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Nervous system disorders DIZZINESS	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	11.4% 4/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders BRONCHITIS	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders HERPES SIMPLEX	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders NAIL DISORDER	5.4% 2/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	2.9% 1/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders SKIN ULCER	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders DYSURIA	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders UREMIA	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders URINARY INCONTINENCE	0.00% 0/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders HEALING ABNORMAL	8.1% 3/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders PNEUMONIA	2.7% 1/37 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	5.7% 2/35 • From post-conversion to the end of the study (Month 36 post-transplant) The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER