Study of Efficacy, Safety, Tolerability, Pharmacokinetic... | NCT03663335

NCT03663335

ID	Type	Description	Link
2017-003607-22	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1/Cohort 1: CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids	Experimental	Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids. Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant. Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.	Biological: CFZ533 - Cohort 1/Cohort 2 Drug: Mycophenolate Mofetil (MMF) Drug: Corticosteroids (CS) Drug: Induction therapy: basiliximab Drug: Induction therapy: rabbit anti-thymocyte globulin (rATG)
Arm 2/Cohort 1: CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids	Experimental	Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids. Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant. Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.	Biological: CFZ533 - Cohort 1/Cohort 2 Drug: Mycophenolate Mofetil (MMF) Drug: Corticosteroids (CS) Drug: Induction therapy: basiliximab Drug: Induction therapy: rabbit anti-thymocyte globulin (rATG)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CFZ533 - Cohort 1/Cohort 2	Biological	CFZ533 was administered either by intravenous infusion or subcutaneous injection	Arm 1/Cohort 1: CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Composite Efficacy Failure Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months Post-transplantation (Cohort 1)	The composite efficacy failure event is defined as any of the following: (1) biopsy-proven acute rejection (BPAR) or (2) graft loss or (3) death. BPAR (BANFF ≥ 1A) is based on the central and adjudicated assessments. Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted. If the participant underwent allograft nephrectomy prior to start of permanent dialysis, the day of the nephrectomy was day of graft loss.	12 Months
Percentage of Participants With Composite Efficacy Failure Event (BPAR, Graft Loss or Death) Over 12 Months Post-conversion (Cohort 2)	The composite efficacy failure event is defined as any of the following: (1) biopsy-proven acute rejection (BPAR) or (2) graft loss or (3) death. BPAR (BANFF ≥ 1A) is based on the central and adjudicated assessments. Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted. If the participant underwent allograft nephrectomy prior to start of permanent dialysis, the day of the nephrectomy was day of graft loss.	12 Months

Secondary Outcomes

Measure	Description	Time Frame
Cohort 1: Mean Estimated Glomerular Filtration Rate (eGFR) ((MDRD4) at 12 Months Post-transplantation	In the de novo population (Cohort 1), the mean eGFR at Month 12 post-transplantation was the endpoint of interest. Estimated GFR using central laboratory serum creatinine values was calculated using the MDRD4 formula.	12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Key inclusion criteria for both cohorts

Written informed consent obtained before any assessment.
Male or female patient ≥ 18 years old.
Up to date vaccination as per local immunization schedules.

Key inclusion criteria specific to Cohort 1:

Recipients of a primary kidney transplant from a brain-dead donor, living unrelated or non-human leukocyte antigen (HLA) identical living related donors.
Recipients of a kidney with a cold ischemia time < 24 hours.

Key inclusion criteria specific to Cohort 2:

Recipients of a primary graft received 6 to 24 months prior enrollment, on a regimen containing TAC+MMF/ Enteric-coated mycophenolate sodium (EC-MPS)±corticosteroids (CS).
Patients with an actual eGFR according to Modification of Diet in Renal Disease (MDRD-4) ≥ 45 mL/min/1.73m2.

Exclusion Criteria:

Key exclusion criteria for both cohorts

Recipient who tests positive for anti-HIV, HBsAg or anti-HCV (without proof of sustained viral response (SVR12) after anti-HCV treatment) within 28 days prior to baseline visit.
Recipient who tests negative for Epstein Barr virus (EBV) within 28 days prior to baseline visit.
Evidence of advanced liver disease (Child-Pugh C), or any sign of liver decompensation.
Patient with severe systemic infections, current or within the two weeks prior to randomization.
History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases, with the exception of localized excised non-melanomatous skin lesions.
Patients who weighed less than 30 kg or more than 180 kg.

Key exclusion criteria specific to Cohort 1:

Multi-organ transplant recipients, including en bloc and dual kidney transplantation, or prior kidney transplant
Recipients of an organ from a donor after cardiac death.
Recipient of an organ from an HLA identical living related donor.
ABO incompatible or complement-dependent lymphocytotoxic crossmatch positive transplant (isolated positive B cell crossmatches were not an exclusion criterion).
Recipients of kidneys from donors who were older than >65 years.
Recipients of kidneys from donors with terminal serum creatinine > 2 mg/dL.
Patients at high immunological risk for rejection as determined for assessment of anti-donor reactivity:
high panel reactive antibodies> 20% or
Presence of pre-formed DSA. Results 12 weeks prior to enrollment were acceptable if no blood transfusion or abortion occurred during this period.
Recipient of a kidney from a donor who tests positive for HIV, HBsAg or HCV.

Key exclusion criteria to Cohort 2

Recipients of a kidney re-transplant.
Recipient of a multi-organ transplant, including en bloc and dual kidney transplantation.
DSA within 12 weeks prior enrollment.
eGFR decline ≥10.0 mL/min within 12 weeks prior enrollment.
Ongoing rejection or rejection that required treatment within 12 weeks prior enrollment.
Severe humoral and/or cellular rejection (BANFF ≥ IIb) within 12 weeks before enrollment.
Proteinuria > 1 g/day or UPCR >1.2 mg/mg at time of enrollment

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Los Angeles	California	90033	United States
Novartis Investigative Site

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids	Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids. Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant. Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 18, 2021	Oct 28, 2022

Arm/Group Information

ID	Title	Description
BG000	Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids	Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids. Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant. Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
BG001	Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids	Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids. Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant. Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.
BG002	Arm 3/Cohort 1 (De Novo Cohort): Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids	Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids.
BG003	Arm 1/Cohort 2 (Maintenance Cohort): CFZ533 450 mg + MMF ± Corticosteroids	Eligible patients who were 6 to 24 months post renal transplantation and were on a stable regimen containing TAC+MMF/Enteric-coated mycophenolate sodium (EC-MPS)±CS were randomized to CFZ533 450 mg sc Q2W. On Day 1, patients randomized to Arm 1 were administered the 1st dose of CFZ533 at 30 mg/kg IV, concomitantly with MMF/EC-MPS and 50% of the current TAC dose. At Day 15, CFZ533 was administered sc 450 mg (1 injection of 2 mL & 1 injection of 1 mL CFZ533 at 150 mg/mL) concomitantly with MMF/EC-MPS, and TAC reduced by a further 50%. By Day 29, patients were fully tapered off their TAC. Subsequent doses of 450 mg sc Q2W, were administered in combination with MMF/EC-MPS with or without corticosteroids, up to Month 59.5 visit.
BG004	Arm 2/Cohort 2 (Maintenance Cohort): TAC + MMF ± Corticosteroids	Patients continued to receive the same immunosuppressive regimen (same drugs) as before entering the study. Patients on a once daily TAC formulation could continue with this regimen.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

Participants

Title

Denominators

Categories

< 60 years

Title	Measurements
	BG00086 BG00179 BG00254 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00034 BG00132 BG002

Race/Ethnicity, Customized

Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. Mis-randomized patients were defined as cases where IRT contacts were made by the Investigator/qualified site staff either prematurely or inappropriately for confirmation of the patient's final randomization eligibility and treatment was not administered to the patient.

Number

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG00084 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Composite Efficacy Failure Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months Post-transplantation (Cohort 1)

The composite efficacy failure event is defined as any of the following:

(1) biopsy-proven acute rejection (BPAR) or (2) graft loss or (3) death. BPAR (BANFF ≥ 1A) is based on the central and adjudicated assessments. Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted. If the participant underwent allograft nephrectomy prior to start of permanent dialysis, the day of the nephrectomy was day of graft loss.

Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients. The analysis was based on the number of patients with composite efficacy failure up to Month 12 per-protocol central and adjudicated assessment.

Posted

Number

Percentage of participants

12 Months

ID	Title	Description
OG000	Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids	Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids. Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant. Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
OG001	Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids	Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids. Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant. Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.
OG002	Arm 3/Cohort 1 (De Novo Cohort): Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids	Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids.

Units	Counts
Participants	OG00066 OG00170 OG00241

Title

Denominators

Categories

Title	Measurements
	OG00060.6 OG00138.6 OG00222.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002						Rate Difference	15.80			2-Sided	95	3.86	27.74					Non-Inferiority	The non-inferiority (NI) margin was set at 20%.	posterior probability rate difference 0.2 <=0.754
OG001 OG002

Primary

Percentage of Participants With Composite Efficacy Failure Event (BPAR, Graft Loss or Death) Over 12 Months Post-conversion (Cohort 2)

The composite efficacy failure event is defined as any of the following:

Posted

Number

Percentage of participants

12 Months

ID	Title	Description
OG000	Arm 1/Cohort 2 (Maintenance Cohort): CFZ533 450 mg + MMF ± Corticosteroids	Eligible patients who were 6 to 24 months post renal transplantation and were on a stable regimen containing TAC+MMF/Enteric-coated mycophenolate sodium (EC-MPS)±CS were randomized to CFZ533 450 mg sc Q2W. On Day 1, patients randomized to Arm 1 were administered the 1st dose of CFZ533 at 30 mg/kg IV, concomitantly with MMF/EC-MPS and 50% of the current TAC dose. At Day 15, CFZ533 was administered sc 450 mg (1 injection of 2 mL & 1 injection of 1 mL CFZ533 at 150 mg/mL) concomitantly with MMF/EC-MPS, and TAC reduced by a further 50%. By Day 29, patients were fully tapered off their TAC. Subsequent doses of 450 mg sc Q2W, were administered in combination with MMF/EC-MPS with or without corticosteroids, up to Month 59.5 visit.

Secondary

Cohort 1: Mean Estimated Glomerular Filtration Rate (eGFR) ((MDRD4) at 12 Months Post-transplantation

In the de novo population (Cohort 1), the mean eGFR at Month 12 post-transplantation was the endpoint of interest. Estimated GFR using central laboratory serum creatinine values was calculated using the MDRD4 formula.

Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients.

Posted

Mean

Standard Error

mL/min/1.73m^2

12 months

ID	Title	Description
OG000	Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids	Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids. Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant. Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
OG001	Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids	Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids. Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant. Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit.

Secondary

Cohort 2: Mean Change in Estimated Glomerular Filtration Rate (eGFR) ((MDRD4) at 12 Months Post-conversion

In the maintenance population (Cohort 2), a baseline kidney function and the mean change from baseline at Month 12 post-conversion of eGFR was the endpoint of interest. Estimated GFR using central laboratory serum creatinine values was calculated using the MDRD4 formula.

Full Analysis Set (FAS): all patients who received transplantation and randomized, excluding mis-randomized patients.

Posted

Mean

Standard Error

mL/min/1.73m^2

12 months

ID	Title	Description
OG000	Arm 1/Cohort 2 (Maintenance Cohort): CFZ533 450 mg + MMF ± Corticosteroids	Eligible patients who were 6 to 24 months post renal transplantation and were on a stable regimen containing TAC+MMF/Enteric-coated mycophenolate sodium (EC-MPS)±CS were randomized to CFZ533 450 mg sc Q2W. On Day 1, patients randomized to Arm 1 were administered the 1st dose of CFZ533 at 30 mg/kg IV, concomitantly with MMF/EC-MPS and 50% of the current TAC dose. At Day 15, CFZ533 was administered sc 450 mg (1 injection of 2 mL & 1 injection of 1 mL CFZ533 at 150 mg/mL) concomitantly with MMF/EC-MPS, and TAC reduced by a further 50%. By Day 29, patients were fully tapered off their TAC. Subsequent doses of 450 mg sc Q2W, were administered in combination with MMF/EC-MPS with or without corticosteroids, up to Month 59.5 visit.
OG001	Arm 2/Cohort 2 (Maintenance Cohort): TAC + MMF ± Corticosteroids

Secondary

Free CFZ533 Plasma Concentrations Over Time (Cohort 1)

Pharmacokinetics were determined for free CFZ533 plasma concentrations during the treatment period.

Pharmacokinetics analysis set (PK): all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PD, e.g. if a dose was taken more than 7 days after the planned date.

The PK analysis set has 2 more patients than the FAS as these patients took study medication but did not undergo transplantation.

Posted

Mean

Standard Deviation

µg/mL

Day 1-Pre-Dose to Month 30-Pre-Dose

ID	Title	Description
OG000	Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids	Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids. Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant. Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
OG001	Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids

Secondary

Free CFZ533 Plasma Concentrations Over Time (Cohort 2)

Pharmacokinetics were determined for free CFZ533 plasma concentrations during the treatment period.

Posted

Mean

Standard Deviation

µg/mL

Day 1-Pre-Dose to Month 30-Pre-Dose

ID	Title	Description
OG000	Arm 1/Cohort 2 (Maintenance Cohort): CFZ533 450 mg + MMF ± Corticosteroids	Eligible patients who were 6 to 24 months post renal transplantation and were on a stable regimen containing TAC+MMF/Enteric-coated mycophenolate sodium (EC-MPS)±CS were randomized to CFZ533 450 mg sc Q2W. On Day 1, patients randomized to Arm 1 were administered the 1st dose of CFZ533 at 30 mg/kg IV, concomitantly with MMF/EC-MPS and 50% of the current TAC dose. At Day 15, CFZ533 was administered sc 450 mg (1 injection of 2 mL & 1 injection of 1 mL CFZ533 at 150 mg/mL) concomitantly with MMF/EC-MPS, and TAC reduced by a further 50%. By Day 29, patients were fully tapered off their TAC. Subsequent doses of 450 mg sc Q2W, were administered in combination with MMF/EC-MPS with or without corticosteroids, up to Month 59.5 visit.
OG001	Arm 2/Cohort 2 (Maintenance Cohort): TAC + MMF ± Corticosteroids	Patients received TAC-based regimen throughout the study.

Secondary

Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 1)

The presence of anti-CFZ533 antibodies was assessed using screening and confirmatory assays.

The PK analysis set has 2 more patients than the FAS as these patients took study medication but did not undergo transplantation.

Posted

Number

Participants

24 Months

ID	Title	Description
OG000	Arm 1/Cohort 1 (De Novo Cohort): CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids	Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids. Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant. Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit.
OG001	Arm 2/Cohort 1 (De Novo Cohort): CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids

Secondary

Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 2)

The presence of anti-CFZ533 antibodies was assessed using screening and confirmatory assays.

Posted

Number

Participants

24 Months

ID	Title	Description
OG000	Arm 1/Cohort 2 (Maintenance Cohort): CFZ533 450 mg + MMF ± Corticosteroids	Eligible patients who were 6 to 24 months post renal transplantation and were on a stable regimen containing TAC+MMF/Enteric-coated mycophenolate sodium (EC-MPS)±CS were randomized to CFZ533 450 mg sc Q2W. On Day 1, patients randomized to Arm 1 were administered the 1st dose of CFZ533 at 30 mg/kg IV, concomitantly with MMF/EC-MPS and 50% of the current TAC dose. At Day 15, CFZ533 was administered sc 450 mg (1 injection of 2 mL & 1 injection of 1 mL CFZ533 at 150 mg/mL) concomitantly with MMF/EC-MPS, and TAC reduced by a further 50%. By Day 29, patients were fully tapered off their TAC. Subsequent doses of 450 mg sc Q2W, were administered in combination with MMF/EC-MPS with or without corticosteroids, up to Month 59.5 visit.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pre-treatment	from randomization until first treatment to report pre-treatment mortalities	1	403	0	0	0	0
EG001	De Novo Cohort: CFZ533 600 mg + MMF + CS/On-treatment Period	From first dose up to 14 days after last dose of CFZ533	2	108	71	108	105	108
EG002	De Novo Cohort: CFZ533 600 mg + MMF + CS/Post- Treatment Safety Follow-up Period	From day 15 after last CFZ533 dose till completion of the 14 weeks safety follow up. Note: patients may have switched to Standard of care.	5	108	18	108	20	108
EG003	De Novo Cohort: CFZ533 600 mg + MMF + CS/Post- Treatment Survival Follow-up Period	After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.	2	108	0	0	0	0
EG004	De Novo Cohort: CFZ533 300 mg + MMF + CS/On-treatment Period	From first dose up to 14 days after last dose of CFZ533	0	109	76	109	102	109
EG005	De Novo Cohort: CFZ533 300 mg + MMF + CS/Post-treatment Safety Follow-up Period	From day 15 after last CFZ533 dose till completion of the 14 weeks safety follow up. Note: patients may have switched to Standard of care.	1	109	19	109	19	109
EG006	De Novo Cohort: CFZ533 300 mg + MMF + CS/Post- Treatment Survival Follow-up Period	After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.	0	109	0	0	0	0
EG007	De Novo Cohort: TAC + MMF + CS/On-treatment Period	From 1st dose to last dose of TAC	1	73	39	73	67	73
EG008	De Novo Cohort: TAC + MMF + CS/Post-treatment Safety Follow-up Period	From day 1 after last dose of TAC till completion of the 12 weeks safety follow up. Note: patients may have switched to Standard of care.	0	73	3	73	4	73
EG009	De Novo Cohort: TAC + MMF + CS/Post- Treatment Survival Follow-up Period	After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.	0	73	0	0	0	0
EG010	Maintenance Cohort: CFZ533 450 mg + MMF +/- CS/On-treatment Period	From first dose up to 14 days after last dose of CFZ533	0	70	25	70	54	70
EG011	Maintenance Cohort: CFZ533 450 mg + MMF +/- CS/Post-treatment Safety Follow-up Period	From day 15 after last CFZ533 dose till completion of the 14 weeks safety follow up. Note: patients may have switched to Standard of care.	1	70	4	70	4	70
EG012	Maintenance Cohort: CFZ533 450 mg + MMF +/- CS/Post- Treatment Survival Follow-up Period	After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.	0	70	0	0	0	0
EG013	Maintenance Cohort: TAC + MMF +/- CS/On-treatment Period	From 1st dose to last dose of TAC	1	42	11	42	26	42
EG014	Maintenance Cohort: TAC + MMF +/- CS/Post-treatment Safety Follow-up Period	From day 1 after last dose of TAC till completion of the 12 weeks safety follow up. Note: patients may have switched to Standard of care.	1	42	1	42	0	42
EG015	Maintenance Cohort: TAC + MMF +/- CS/Post- Treatment Survival Follow-up Period	After 14 weeks safety follow-up to end of study. Adverse Events were not collected during this period.	0	42	0	0	0	0

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG0030 at risk EG0042 affected109 at risk EG0050 affected109 at risk EG0060 at risk EG0070 affected73 at risk EG0080 affected73 at risk EG0090 at risk EG0101 affected70 at risk EG0110 affected70 at risk EG0120 at risk EG0130 affected42 at risk EG0140 affected42 at risk EG0150 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Adrenal insufficiency	Endocrine disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Goitre	Endocrine disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Hyperaldosteronism	Endocrine disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Hyperparathyroidism	Endocrine disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Hyperparathyroidism secondary	Endocrine disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Photophobia	Eye disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Retinal detachment	Eye disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Uveitis	Eye disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Asthenia	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Chest pain	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Chills	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Fatigue	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
General physical health deterioration	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Hernia	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Hyperthermia	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Inflammation	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Pyrexia	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0014 affected108 at risk EG0020 affected108 at risk EG003
Anti-neutrophil cytoplasmic antibody positive vasculitis	Immune system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Transplant rejection	Immune system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00116 affected108 at risk EG0020 affected108 at risk EG003
Adenovirus infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
BK virus infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0021 affected108 at risk EG003
Bacteraemia	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Bronchitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
COVID-19	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0015 affected108 at risk EG0020 affected108 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Campylobacter infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Candida infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Cellulitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0021 affected108 at risk EG003
Cerebral toxoplasmosis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0021 affected108 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Cryptococcal meningoencephalitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Cytomegalovirus chorioretinitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0021 affected108 at risk EG003
Cytomegalovirus colitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Cytomegalovirus gastritis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Cytomegalovirus hepatitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00116 affected108 at risk EG0022 affected108 at risk EG003
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Infected lymphocele	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0021 affected108 at risk EG003
Infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Influenza	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Localised infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Ophthalmic herpes zoster	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Parotitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Parvovirus B19 infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Pneumocystis jirovecii infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Pneumonia	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0013 affected108 at risk EG0021 affected108 at risk EG003
Pneumonia legionella	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Polyomavirus-associated nephropathy	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0022 affected108 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Prostatitis Escherichia coli	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Renal abscess	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Rhinitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Sepsis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0021 affected108 at risk EG003
Septic shock	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0021 affected108 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Suspected COVID-19	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Toxoplasmosis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0015 affected108 at risk EG0021 affected108 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Urinary tract infection enterococcal	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Urosepsis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Wound infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0021 affected108 at risk EG003
Delayed graft function	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0016 affected108 at risk EG0020 affected108 at risk EG003
Graft complication	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Graft ischaemia	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Graft loss	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Nerve injury	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Postoperative lymphocele	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Procedural shock	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Transplant dysfunction	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0014 affected108 at risk EG0020 affected108 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Blood creatinine increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0014 affected108 at risk EG0021 affected108 at risk EG003
Blood glucose increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Troponin increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Weight decreased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Diabetic complication	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Anosmia	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Guillain-Barre syndrome	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Headache	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Hypertensive encephalopathy	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Intensive care unit acquired weakness	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Ischaemic neuropathy	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Mononeuropathy multiplex	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Quadrantanopia	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Radiculitis brachial	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Seizure	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Device dislocation	Product Issues	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0013 affected108 at risk EG0023 affected108 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Glomerulonephritis	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Perinephric collection	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Renal artery stenosis	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Renal cyst haemorrhage	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Renal infarct	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Renal ischaemia	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Renal tubular necrosis	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Renal vein thrombosis	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Subcapsular renal haematoma	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Ureteric stenosis	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Urinary fistula	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Urinary tract disorder	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Acquired hydrocele	Reproductive system and breast disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Arterial stenosis	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Arterial thrombosis	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Haematoma	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Hypotension	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Iliac artery stenosis	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Lymphocele	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0022 affected108 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Shock	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Subclavian artery stenosis	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Varicose ulceration	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Bicytopenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0021 affected108 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0021 affected108 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Mesenteric panniculitis	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Malaise	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0021 affected108 at risk EG003
Hepatic cytolysis	Hepatobiliary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Device related infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0021 affected108 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0022 affected108 at risk EG003
H1N1 influenza	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0021 affected108 at risk EG003
Leishmaniasis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0021 affected108 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0021 affected108 at risk EG003
Pseudomonas infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Tuberculosis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Blood creatine increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Clostridium test positive	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0021 affected108 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Syncope	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0021 affected108 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Urethral obstruction	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0020 affected108 at risk EG003
Infarction	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0010 affected108 at risk EG0021 affected108 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00136 affected108 at risk EG0020 affected108 at risk EG0030 at risk EG00423 affected109 at risk EG0051 affected109 at risk EG0060 at risk EG00712 affected73 at risk EG0082 affected73 at risk EG0090 at risk EG0104 affected70 at risk EG0111 affected70 at risk EG0120 at risk EG0133 affected42 at risk EG0140 affected42 at risk EG0150 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0016 affected108 at risk EG0020 affected108 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00131 affected108 at risk EG0024 affected108 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00114 affected108 at risk EG0021 affected108 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0019 affected108 at risk EG0020 affected108 at risk EG003
Polycythaemia	Blood and lymphatic system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0018 affected108 at risk EG0021 affected108 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0013 affected108 at risk EG0020 affected108 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00130 affected108 at risk EG0022 affected108 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00119 affected108 at risk EG0025 affected108 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0014 affected108 at risk EG0021 affected108 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0016 affected108 at risk EG0020 affected108 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00113 affected108 at risk EG0021 affected108 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00112 affected108 at risk EG0020 affected108 at risk EG003
Asthenia	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Fatigue	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00110 affected108 at risk EG0020 affected108 at risk EG003
Oedema peripheral	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00121 affected108 at risk EG0023 affected108 at risk EG003
Pyrexia	General disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00120 affected108 at risk EG0023 affected108 at risk EG003
BK virus infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00113 affected108 at risk EG0021 affected108 at risk EG003
Bronchitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0017 affected108 at risk EG0020 affected108 at risk EG003
COVID-19	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0019 affected108 at risk EG0020 affected108 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00115 affected108 at risk EG0023 affected108 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0013 affected108 at risk EG0020 affected108 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0014 affected108 at risk EG0021 affected108 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0018 affected108 at risk EG0021 affected108 at risk EG003
Oral herpes	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0017 affected108 at risk EG0021 affected108 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0018 affected108 at risk EG0021 affected108 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00119 affected108 at risk EG0023 affected108 at risk EG003
Delayed graft function	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0017 affected108 at risk EG0020 affected108 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00113 affected108 at risk EG0020 affected108 at risk EG003
Transplant dysfunction	Injury, poisoning and procedural complications	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0018 affected108 at risk EG0020 affected108 at risk EG003
Blood creatinine increased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0014 affected108 at risk EG0020 affected108 at risk EG003
Cytomegalovirus test positive	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00110 affected108 at risk EG0020 affected108 at risk EG003
Neutrophil count decreased	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00113 affected108 at risk EG0020 affected108 at risk EG003
SARS-CoV-2 test negative	Investigations	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0016 affected108 at risk EG0020 affected108 at risk EG003
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0015 affected108 at risk EG0020 affected108 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00112 affected108 at risk EG0024 affected108 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00118 affected108 at risk EG0021 affected108 at risk EG003
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0016 affected108 at risk EG0020 affected108 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0015 affected108 at risk EG0020 affected108 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00121 affected108 at risk EG0023 affected108 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0017 affected108 at risk EG0023 affected108 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00112 affected108 at risk EG0021 affected108 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0014 affected108 at risk EG0020 affected108 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0015 affected108 at risk EG0020 affected108 at risk EG003
Steroid diabetes	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0019 affected108 at risk EG0020 affected108 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0016 affected108 at risk EG0021 affected108 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0016 affected108 at risk EG0020 affected108 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0015 affected108 at risk EG0022 affected108 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0021 affected108 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0013 affected108 at risk EG0020 affected108 at risk EG003
Dizziness	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0013 affected108 at risk EG0020 affected108 at risk EG003
Headache	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00115 affected108 at risk EG0021 affected108 at risk EG003
Tremor	Nervous system disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0012 affected108 at risk EG0020 affected108 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0019 affected108 at risk EG0020 affected108 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0013 affected108 at risk EG0021 affected108 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0015 affected108 at risk EG0020 affected108 at risk EG003
Perinephric collection	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0016 affected108 at risk EG0021 affected108 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0013 affected108 at risk EG0021 affected108 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00111 affected108 at risk EG0021 affected108 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0019 affected108 at risk EG0020 affected108 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00110 affected108 at risk EG0022 affected108 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0016 affected108 at risk EG0020 affected108 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0016 affected108 at risk EG0020 affected108 at risk EG003
Haematoma	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0011 affected108 at risk EG0020 affected108 at risk EG003
Hypertension	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00136 affected108 at risk EG0021 affected108 at risk EG003
Hypotension	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG00112 affected108 at risk EG0022 affected108 at risk EG003
Lymphocele	Vascular disorders	MedDRA (24.1)	Systematic Assessment	EG0000 at risk EG0014 affected108 at risk EG0020 affected108 at risk EG003

ID	Term
D009173	Mycophenolic Acid
D000305	Adrenal Cortex Hormones
D016559	Tacrolimus

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005227	Fatty Acids
D008055	Lipids
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D018942	Macrolides
D007783	Lactones