Trial Outcomes & Findings for A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients. (NCT NCT00545402)

NCT ID: NCT00545402

Last Updated: 2014-07-14

Results Overview

Banff criteria required at least 2 of the 3 following features for a histopathological diagnosis of acute rejection: portal inflammation, bile duct inflammation, and venous endothelial inflammation. Each item was graded from 0 to 3 where 0 equals (=) mild, 2 = moderate, and 3 = severe. The sum of the 3 individual scores, from 0 to 9, corresponded to the Rejection Activity Index (RAI). If RAI = 0, 1, or 2, there was no evidence of rejection. If RAI = 3, there was borderline acute rejection. If RAI = 4 or 5, there was mild acute rejection. If RAI = 6 or 7, there was moderate acute rejection. If RAI = 8 or 9, there was severe acute rejection.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 180 participants
• Primary outcome timeframe: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment
• Results posted on: 2014-07-14

Participant Flow

Participant milestones

Measure	Adjusted Mycophenolate Mofetil (MMF)+Tacrolimus+Corticosteroid Participants received MMF tablets or capsules, 3 grams per day (g/d), orally (PO), twice daily (BID) with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (area under the concentration-time curve \[AUC\]) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 nanograms per milliliter (ng/mL) from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an intravenous (IV) bolus of methylprednisolone 10-15 milligrams per kilogram (mg/kg) pre-operative on Day 0 per standard practice of the center.	Fixed-Dose MMF + Tacrolimus + Corticosteroid (CS) Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Overall Study STARTED	90	90
Overall Study COMPLETED	56	61
Overall Study NOT COMPLETED	34	29

Reasons for withdrawal

Measure	Adjusted Mycophenolate Mofetil (MMF)+Tacrolimus+Corticosteroid Participants received MMF tablets or capsules, 3 grams per day (g/d), orally (PO), twice daily (BID) with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (area under the concentration-time curve \[AUC\]) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 nanograms per milliliter (ng/mL) from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an intravenous (IV) bolus of methylprednisolone 10-15 milligrams per kilogram (mg/kg) pre-operative on Day 0 per standard practice of the center.	Fixed-Dose MMF + Tacrolimus + Corticosteroid (CS) Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Overall Study Discontinuation of treatment	17	9
Overall Study Use of unauthorized immunosuppressant	8	7
Overall Study Death	5	7
Overall Study Graft loss	2	4
Overall Study Withdrawal by Subject	0	1
Overall Study Protocol Violation	1	0
Overall Study Reason not specified	1	1

Baseline Characteristics

A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.

Baseline characteristics by cohort

Measure	Adjusted MMF + Tacrolimus + CS n=90 Participants Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.	Fixed-Dose MMF + Tacrolimus + CS n=90 Participants Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.	Total n=180 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 8.5 • n=93 Participants	55.1 years STANDARD_DEVIATION 8.3 • n=4 Participants	54.2 years STANDARD_DEVIATION 8.4 • n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	19 Participants n=4 Participants	35 Participants n=27 Participants
Sex: Female, Male Male	74 Participants n=93 Participants	71 Participants n=4 Participants	145 Participants n=27 Participants

PRIMARY outcome

Timeframe: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment

Population: ITT population

Banff criteria required at least 2 of the 3 following features for a histopathological diagnosis of acute rejection: portal inflammation, bile duct inflammation, and venous endothelial inflammation. Each item was graded from 0 to 3 where 0 equals (=) mild, 2 = moderate, and 3 = severe. The sum of the 3 individual scores, from 0 to 9, corresponded to the Rejection Activity Index (RAI). If RAI = 0, 1, or 2, there was no evidence of rejection. If RAI = 3, there was borderline acute rejection. If RAI = 4 or 5, there was mild acute rejection. If RAI = 6 or 7, there was moderate acute rejection. If RAI = 8 or 9, there was severe acute rejection.

Outcome measures

Measure	Adjusted MMF + Tacrolimus + CS n=87 Participants Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.	Fixed-Dose MMF + Tacrolimus + CS n=87 Participants Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant	8.0 percentage of participants	8.2 percentage of participants

SECONDARY outcome

Timeframe: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.

Population: ITT population

Graft survival was defined as the time between the randomization date and the graft loss date. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.

Outcome measures

Measure	Adjusted MMF + Tacrolimus + CS n=90 Participants Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.	Fixed-Dose MMF + Tacrolimus + CS n=90 Participants Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Percentage of Participants With Graft Loss	2.2 percentage of participants	5.6 percentage of participants

SECONDARY outcome

Timeframe: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.

Population: ITT population

The median time, in months, between randomization and graft loss event. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.

Outcome measures

Measure	Adjusted MMF + Tacrolimus + CS n=90 Participants Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.	Fixed-Dose MMF + Tacrolimus + CS n=90 Participants Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Graft Survival	12.9 months Interval 0.0 to 24.5	12.9 months Interval 0.0 to 20.2

SECONDARY outcome

Timeframe: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12

Population: ITT population

OS was defined as the time between the date of randomization and death up to Month 12. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.

Outcome measures

Measure	Adjusted MMF + Tacrolimus + CS n=90 Participants Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.	Fixed-Dose MMF + Tacrolimus + CS n=90 Participants Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Overall Survival (OS) at Month 12 - Percentage of Participants With an Event	8.9 percentage of participants	11.1 percentage of participants

SECONDARY outcome

Timeframe: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12

Population: ITT population

The median time, in months, between randomization and OS event. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.

Outcome measures

Measure	Adjusted MMF + Tacrolimus + CS n=90 Participants Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.	Fixed-Dose MMF + Tacrolimus + CS n=90 Participants Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Overall Survival at Month 12	12.9 months Interval 0.0 to 24.5	12.9 months Interval 0.1 to 20.2

SECONDARY outcome

Timeframe: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12

Population: ITT population; only participants with evaluable biopsies were included in the analysis.

The percentage of participants with biopsies of grafts evaluated by central review and scored according to Banff criteria at Month 12 post-transplant.

Outcome measures

Measure	Adjusted MMF + Tacrolimus + CS n=42 Participants Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.	Fixed-Dose MMF + Tacrolimus + CS n=35 Participants Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review Normal liver	4.8 percentage of participants	11.4 percentage of participants
Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review Minor lesions	4.8 percentage of participants	17.1 percentage of participants
Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review Acute rejection	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review Chronic rejection	7.1 percentage of participants	2.9 percentage of participants
Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review Chronic hepatitis	26.2 percentage of participants	22.9 percentage of participants
Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review Vascular lesions	35.7 percentage of participants	11.4 percentage of participants
Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review Pathology of biliary obstruction	4.8 percentage of participants	5.7 percentage of participants
Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review Lobular hepatitis	4.8 percentage of participants	2.9 percentage of participants
Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review Recurrence of initial autoimmune disease	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review Other	35.7 percentage of participants	45.7 percentage of participants

Adverse Events

Adjusted MMF + Tacrolimus + CS

Serious events: 70 serious events

Other events: 91 other events

Deaths: 0 deaths

Fixed-Dose MMF + Tacrolimus + CS

Serious events: 69 serious events

Other events: 91 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adjusted MMF + Tacrolimus + CS n=91 participants at risk Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.	Fixed-Dose MMF + Tacrolimus + CS n=92 participants at risk Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Cardiac disorders Cardiogenic shock	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Myocardial infarction	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Liver function test abnormal	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Hepatitis C	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	7.6% 7/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Sepsis	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Septic shock	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Peritoneal infection	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Biliary sepsis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Candida sepsis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Cytomegalovirus infection	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Appendicitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Arthritis bacterial	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Aspergillosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Bacterial sepsis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Cytomegalovirus colitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Device related infection	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Enterocolitis infectious	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Hepatitis E	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Herpes zoster	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Liver abscess	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Nocardiosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Pneumocystis jiroveci pneumonia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Pneumonia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Pneumonia cytomegaloviral	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Systemic candida	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Urinary tract infection	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Viral diarrhoea	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Diarrhoea	6.6% 6/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Inguinal hernia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Ascites	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Abdominal hernia	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Peritonitis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Pancreatitis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Peritoneal haemorrhage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Umbilical hernia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Vomiting	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Abdominal wall haematoma	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Gastrointestinal necrosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Intestinal haemorrhage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Intra-abdominal haemorrhage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Small intestinal obstruction	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Volvulus of small bowel	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Bile duct stenosis	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Cholangitis	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic artery thrombosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic artery stenosis	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Biliary fistula	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Cholestasis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Cytolytic hepatitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Bile duct necrosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Biliary cyst	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Biliary tract disorder	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Cholelithiasis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic artery aneurysm	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic ischaemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic vein stenosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Renal failure acute	15.4% 14/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Renal failure	6.6% 6/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	6.5% 6/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Ureteric stenosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Biliary anastomosis complication	5.5% 5/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	6.5% 6/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Anastomotic stenosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Graft dysfunction	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Overdose	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Wound dehiscence	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Complications of transplant surgery	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Complications of transplanted liver	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Endotracheal intubation complication	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Graft thrombosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Wound evisceration	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Multi-organ failure	5.5% 5/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders General physical health deterioration	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Chest pain	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Pyrexia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Sudden death	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Hyperthermia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Inflammation	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Malaise	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Ulcer haemorrhage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Lung disorder	5.5% 5/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Anaemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Neutropenia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Agranulocytosis	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Febrile neutropenia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Leukopenia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Pancytopenia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Haemolytic anaemia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Shock haemorrhagic	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Arterial haemorrhage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Aneurysm	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Angiopathy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Arterial stenosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Arterial thrombosis limb	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Haematoma	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Haemodynamic instability	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Jugular vein thrombosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Thrombosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Vascular stenosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Venous thrombosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hyperkalaemia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Cell death	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Encephalopathy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Epilepsy	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Cerebral haemorrhage	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Cerebral ischaemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Cerebrovascular accident	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Coma	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Convulsion	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Febrile convulsion	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Metabolic encephalopathy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Neuropathy peripheral	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Toxic encephalopathy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Vocal cord paresis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Confusional state	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Mental disorder	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Delirium	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Depression	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Ventricular tachycardia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Cardio-respiratory arrest	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Cytomegalovirus antibody positive	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Oesophagogastroduodenoscopy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Surgical and medical procedures Biliary anastomosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Surgical and medical procedures Biliary drainage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Surgical and medical procedures Catheter removal	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Surgical and medical procedures Surgical vascular shunt	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Reproductive system and breast disorders Prostatitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Reproductive system and breast disorders Testicular torsion	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Congenital, familial and genetic disorders Hereditary neuropathic amyloidosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Endocrine disorders Hyperparathyroidism	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Immune system disorders Liver transplant rejection	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.

Other adverse events

Measure	Adjusted MMF + Tacrolimus + CS n=91 participants at risk Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.	Fixed-Dose MMF + Tacrolimus + CS n=92 participants at risk Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
Gastrointestinal disorders Diarrhoea	34.1% 31/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	28.3% 26/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Abdominal pain	13.2% 12/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	13.0% 12/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Ascites	9.9% 9/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	12.0% 11/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Constipation	8.8% 8/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	12.0% 11/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Nausea	8.8% 8/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	8.7% 8/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Vomiting	11.0% 10/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Gastrointestinal disorder	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	7.6% 7/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Inguinal hernia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	7.6% 7/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Abdominal pain upper	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Dyspepsia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Peritonitis	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Abdominal hernia	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Dysphagia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Impaired gastric emptying	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Intra-abdominal haemorrhage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Pancreatitis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Peritoneal haemorrhage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Subileus	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Umbilical hernia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Abdominal wall haematoma	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Coeliac artery stenosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Colitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Duodenal ulcer	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Duodenal ulcer haemorrhage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Duodenitis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Gastric ulcer	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Gastritis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Gastritis erosive	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Gastrointestinal necrosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Gastrointestinal pain	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Haematemesis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Haemorrhoids	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Intestinal haemorrhage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Intestinal obstruction	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Melaena	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Oesophageal ulcer	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Oesophagitis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Oesophagitis ulcerative	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Peritoneal effusion	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Pneumoperitoneum	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Portal venous gas	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Small bowel angioedema	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Small intestinal obstruction	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Stomatitis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Toothache	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Gastrointestinal disorders Volvulus of small bowel	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Anaemia	49.5% 45/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	47.8% 44/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Thrombocytopenia	17.6% 16/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	14.1% 13/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Neutropenia	14.3% 13/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	6.5% 6/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Leukopenia	15.4% 14/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Pancytopenia	12.1% 11/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Deficiency anaemia	6.6% 6/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Leukocytosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Lymphopenia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Agranulocytosis	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Disseminated intravascular coagulation	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Febrile neutropenia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Febrile bone marrow aplasia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Haemolytic anaemia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Idiopathic thrombocytopenic purpura	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Jaundice acholuric	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Thrombocythaemia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Urinary tract infection	14.3% 13/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	15.2% 14/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Hepatitis C	7.7% 7/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	12.0% 11/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Sepsis	9.9% 9/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	8.7% 8/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Cytomegalovirus infection	7.7% 7/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	6.5% 6/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Staphylococcal infection	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	6.5% 6/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Bronchitis	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Septic shock	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infection	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Puncture site infection	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Abdominal wall abscess	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Ascites infection	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Enterococcal infection	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Lung infection	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Peritoneal infection	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Nasopharyngitis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Oral candidiasis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Staphylococcal sepsis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Tonsillitis	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Arthritis bacterial	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Biliary sepsis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Candida sepsis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Catheter related infection	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Clostridial infection	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Device related infection	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Fungal infection	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Gastroenteritis viral	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Herpes zoster	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Postoperative wound infection	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Streptococcal infection	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Abscess	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Appendicitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Aspergillosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Bacterial infection	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Bacterial sepsis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Bronchopulmonary aspergillosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Candidiasis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Cellulitis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Cholecystitis infective	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Citrobacter infection	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Clostridium difficile colitis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Cystitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Cytomegalovirus colitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Cytomegalovirus viraemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Endocarditis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Enterobacter bacteraemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Enterocolitis infectious	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Furuncle	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Hepatitis E	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Hepatobiliary infection	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Herpes simplex	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Influenza	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Infusion site infection	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Liver abscess	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Nocardiosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Oesophageal candidiasis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Oral fungal infection	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Orchitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Paronychia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Pneumocystis jiroveci pneumonia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Pneumonia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Pneumonia cytomegaloviral	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Pseudomonal sepsis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Rhinitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Serratia infection	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Skin infection	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Systemic candida	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Infections and infestations Viral diarrhoea	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hyperkalaemia	16.5% 15/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	15.2% 14/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Diabetes mellitus	6.6% 6/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	20.7% 19/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hyperglycaemia	12.1% 11/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	14.1% 13/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Cell death	13.2% 12/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	8.7% 8/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypokalaemia	5.5% 5/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	8.7% 8/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	5.5% 5/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Dyslipidaemia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Type 1 diabetes mellitus	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Anorexia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypomagnesaemia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypercalcaemia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypoalbuminaemia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Acidosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypocalcaemia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Metabolic acidosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Weight fluctuation	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Cachexia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Dehydration	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Fluid overload	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Gout	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Hypovitaminosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Renal colic	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Lactic acidosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Metabolic syndrome	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Mineral deficiency	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Hypertension	34.1% 31/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	33.7% 31/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Venous thrombosis	7.7% 7/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Haemodynamic instability	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	7.6% 7/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Haemorrhage	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Hypotension	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Haematoma	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Shock haemorrhagic	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Arterial haemorrhage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Vein discolouration	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Aneurysm	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Angiopathy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Arterial stenosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Arterial thrombosis limb	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Hypovolaemic shock	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Jugular vein thrombosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Lymphoedema	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Orthostatic hypotension	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Metabolism and nutrition disorders Phlebitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Thrombophlebitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Thrombosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Vascular stenosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Vascular disorders Venous stasis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Renal failure	26.4% 24/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	25.0% 23/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Renal failure acute	24.2% 22/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	17.4% 16/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Renal impairment	6.6% 6/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	8.7% 8/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Oliguria	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Anuria	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Dysuria	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Micturition disorder	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Polyuria	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Renal pain	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Renal tubular disorder	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Ureteric stenosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Urinary incontinence	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Renal and urinary disorders Urinary retention	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Oedema peripheral	11.0% 10/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	18.5% 17/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Pain	13.2% 12/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	10.9% 10/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Pyrexia	12.1% 11/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Hyperthermia	8.8% 8/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Oedema	7.7% 7/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Multi-organ failure	5.5% 5/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Asthenia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	6.5% 6/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Inflammation	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Chest pain	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders General physical health deterioration	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Hypothermia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Effusion	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Influenza like illness	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Sudden death	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Catheter site necrosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Chills	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Generalised oedema	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Malaise	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Necrosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Polyp	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Ulcer	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
General disorders Ulcer haemorrhage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Cholestasis	26.4% 24/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	20.7% 19/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Cholangitis	5.5% 5/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	6.5% 6/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Bile duct stenosis	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic artery thrombosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	7.6% 7/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Cytolytic hepatitis	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic artery stenosis	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Jaundice	5.5% 5/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Biliary fistula	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Portal vein thrombosis	5.5% 5/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Biloma	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Biliary tract disorder	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic function abnormal	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Biliary cyst	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic cirrhosis	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic failure	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hyperbilirubinaemia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Bile duct necrosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Cholelithiasis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic artery aneurysm	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic ischaemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatic vein stenosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatitis cholestatic	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Hepatobiliary disorders Hepatorenal syndrome	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	24.2% 22/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	27.2% 25/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Lung disorder	14.3% 13/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	9.8% 9/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Cough	5.5% 5/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Respiratory distress	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Hydrothorax	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Respiratory gas exchange disorder	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Confusional state	12.1% 11/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	15.2% 14/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Insomnia	16.5% 15/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	10.9% 10/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Agitation	8.8% 8/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	8.7% 8/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Anxiety	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	13.0% 12/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Depression	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	6.5% 6/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Delirium	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Mental disorder	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Affective disorder	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Hallucination	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Hallucination, visual	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Psychiatric disorders Sleep disorder	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Headache	9.9% 9/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	10.9% 10/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Tremor	8.8% 8/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	9.8% 9/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Convulsion	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Febrile convulsion	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Encephalopathy	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Dizziness	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Dysarthria	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Epilepsy	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Paraesthesia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Syncope vasovagal	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Amnesia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Carpal tunnel syndrome	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Ischaemic stroke	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Polyneuropathy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Somnolence	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Altered state of consciousness	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Aphonia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Cerebral haemorrhage	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Cerebral ischaemia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Cerebrovascular accident	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Cognitive disorder	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Coma	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Depressed level of consciousness	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Hyperreflexia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Memory impairment	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Metabolic encephalopathy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Neuropathy peripheral	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Paresis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Psychomotor skills impaired	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Toxic encephalopathy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Vocal cord paralysis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Nervous system disorders Vocal cord paresis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Biliary anastomosis complication	7.7% 7/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	6.5% 6/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Seroma	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Overdose	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	6.5% 6/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Anastomotic stenosis	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Eschar	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Hepatic haematoma	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Procedural pain	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Wound dehiscence	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Accidental overdose	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Graft dysfunction	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Operative haemorrhage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Endotracheal intubation complication	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Complications of transplant surgery	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Complications of transplanted liver	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Fall	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Foot fracture	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Graft thrombosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Poisoning	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Radiation leukopenia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Radiation oesophagitis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Surgical procedure repeated	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Wound	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Wound evisceration	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Back pain	7.7% 7/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	7.6% 7/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Muscle spasms	5.5% 5/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Osteopenia	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Osteoporosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Pain in extremity	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Hypercreatinaemia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Amyotrophy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Bursitis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Band neutrophil percentage decreased	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Weight decreased	4.4% 4/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Red blood cell count decreased	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Liver function test abnormal	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	5.4% 5/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Weight increased	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Gamma-glutamyltransferase increased	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Blood bilirubin increased	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Blood urea increased	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Haematology test abnormal	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Aspiration tracheal	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Blood glucose	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Cytomegalovirus antibody positive	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Oesophagogastroduodenoscopy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Prothrombin level decreased	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Investigations Serum ferritin increased	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Tachycardia	6.6% 6/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Atrial fibrillation	3.3% 3/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Acute coronary syndrome	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Arrhythmia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Bradycardia	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Pericardial effusion	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Supraventricular tachycardia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Ventricular tachycardia	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Atrial flutter	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Cardiac failure	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Cardio-respiratory arrest	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Cardiogenic shock	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Cardiomyopathy	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Myocardial infarction	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Palpitations	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Pericardial disease	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Stress cardiomyopathy	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Cardiac disorders Ventricular extrasystoles	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Pruritus	8.8% 8/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Skin necrosis	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	4.3% 4/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Erythema	2.2% 2/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Dermatitis exfoliative	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Rash	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Scar pain	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Skin and subcutaneous tissue disorders Vascular purpura	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Immune system disorders Drug hypersensitivity	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	3.3% 3/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Immune system disorders Hypersensitivity	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Immune system disorders Liver transplant rejection	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Immune system disorders Transplant rejection	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Reproductive system and breast disorders Prostatitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Reproductive system and breast disorders Oedema genital	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Reproductive system and breast disorders Ovarian cyst	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Reproductive system and breast disorders Pruritus genital	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Reproductive system and breast disorders Testicular torsion	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Visual acuity reduced	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	2.2% 2/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Visual disturbance	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Eye disorders Uveitis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Surgical and medical procedures Biliary anastomosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Surgical and medical procedures Biliary drainage	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Surgical and medical procedures Catheter removal	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Surgical and medical procedures Skin neoplasm excision	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Surgical and medical procedures Surgical vascular shunt	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Congenital, familial and genetic disorders Hereditary neuropathic amyloidosis	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Congenital, familial and genetic disorders Hydrocele	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Ear and labyrinth disorders Ear haemorrhage	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Ear and labyrinth disorders Ear pain	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Endocrine disorders Hyperparathyroidism	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Endocrine disorders Hyperthyroidism	1.1% 1/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	0.00% 0/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.
Social circumstances Alcohol use	0.00% 0/91 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.	1.1% 1/92 • Adverse events were recorded from study start to 28 days after Month 12 or the last dose of study treatment. All participants who were randomized and received at least one dose of MMF and/or corticosteroids were included in the safety analysis. Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.

Additional Information

Medical Communications

Hoffman-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

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

Restriction type: OTHER