A Study to Evaluate the Efficacy and Safety of a Vaccine,... | NCT01974206

ID	Type	Description	Link
2013-000464-29	EudraCT Number

Name	Class
Vical	INDUSTRY

Label	Type	Description	Intervention Names
ASP0113	Experimental	Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	Biological: ASP0113
Placebo	Placebo Comparator	Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
ASP0113	Biological	intramuscular injection	ASP0113
Placebo

Measure	Description	Time Frame
Percentage of Participants With CMV Viremia Through 1 Year Post First Study Drug Injection	CMV viremia was defined as presence of cytomegalovirus as measured in plasma viral load of ≥ 1000 IU/mL by central laboratory assay. A participant who discontinued the study without a positive CMV viral load was imputed as having a CMV viremia. A participant who had more than one viral load ≥ 1000 IU/mL by central assay was counted once in this summary. CMV viral loads after first injection (Day 1) through Day 380 (scheduled or unscheduled) were included in the analysis.	From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

Measure	Description	Time Frame
Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)	An independent panel of medical experts reviewed/adjudicated events of CMV-associated disease including CMV syndrome and tissue invasive disease, which were defined according to the American Society of Transplantation Recommendations for Screening, Monitoring and Reporting of Infectious Complications in Immunosuppression Trials in Recipients of Organ Transplantation 2006.

Name	Affiliation	Role
Medical Director	Astellas Pharma Global Development, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site US10026		Phoenix	Arizona	85054	United States
Site US10003

PubMed Identifier	Type	Citation	Retractions
29745007	Derived	Vincenti F, Budde K, Merville P, Shihab F, Ram Peddi V, Shah M, Wyburn K, Cassuto-Viguier E, Weidemann A, Lee M, Flegel T, Erdman J, Wang X, Lademacher C. A randomized, phase 2 study of ASP0113, a DNA-based vaccine, for the prevention of CMV in CMV-seronegative kidney transplant recipients receiving a kidney from a CMV-seropositive donor. Am J Transplant. 2018 Dec;18(12):2945-2954. doi: 10.1111/ajt.14925. Epub 2018 Jun 20.

Label	URL
Link to results and other applicable study documents on the Astellas Clinical Trials website	View source

ID	Title	Description
FG000	Placebo	Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
FG001	ASP0113 5mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 6, 2014	Oct 21, 2021

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 CMV Viremia Through 1 Year Post First Study Drug Injection

CMV viremia was defined as presence of cytomegalovirus as measured in plasma viral load of ≥ 1000 IU/mL by central laboratory assay. A participant who discontinued the study without a positive CMV viral load was imputed as having a CMV viremia. A participant who had more than one viral load ≥ 1000 IU/mL by central assay was counted once in this summary. CMV viral loads after first injection (Day 1) through Day 380 (scheduled or unscheduled) were included in the analysis.

The Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of randomized study drug and who had at least 1 post dose viral load assessment within 1 year post first injection by central laboratory.

Posted

Number

Percentage of Paticipants

From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

ID	Title	Description
OG000	Placebo	Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
OG001	ASP0113 5mg	Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).

Units	Counts
Participants	OG00073 OG00173

Title

Denominators

Categories

Known CMV viremia

Title	Measurements
	OG00035.6 OG00135.6

Imputed CMV viremia due to discontinuation

Title	Measurements
	OG000

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 OG001	The Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization strata, and the 90% CIs of the CMH odds ratio stratified by randomization group.	Cochran-Mantel-Haenszel		0.307	P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.	Common Odds Ratio	0.79			2-Sided	90	0.43	1.47					Other

Secondary

Percentage of Participants With Adjudicated CMV-Associated Disease, Including CMV Syndrome and CMV Tissue-Invasive Disease (Primary Study Period)

An independent panel of medical experts reviewed/adjudicated events of CMV-associated disease including CMV syndrome and tissue invasive disease, which were defined according to the American Society of Transplantation Recommendations for Screening, Monitoring and Reporting of Infectious Complications in Immunosuppression Trials in Recipients of Organ Transplantation 2006.

The analysis population was the FAS.

Posted

Number

Percentage of Participants

From first study dose injection (day 1) up to one (up to Day 380) year post study drug injection

ID	Title	Description
OG000	Placebo	Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
OG001	ASP0113 5mg	Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).

Units	Counts

Secondary

Percentage of Participants With Plasma Viral Load ≥ The Lower Limit of Quantification (LLOQ) Assessed by Central Laboratory (Primary Study Period)

The central laboratory had the LLOQ level for CMV viral load assessment. When the viral load was below the LLOQ the actual reading was not possible and was denoted as ≤LLOQ. If the participant had any CMV viral load assessments greater than the LLOQ, set up by the central laboratory, participant was classified as viremic and was included in the analysis.

The analysis population was the FAS.

Posted

Number

Percentage of Participants

From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

ID	Title	Description
OG000	Placebo	Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
OG001	ASP0113 5mg	Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).

Units	Counts

Secondary

Percentage of Participants Who Took Adjudicated CMV-specific Antiviral Therapy for the Treatment of CMV Viremia or Disease (Primary Study Period)

An independent panel of medical experts reviewed/adjudicated events of CMV-specific AVT for treatment of CMV viremia or disease.

The analysis population was the FAS.

Posted

Number

Percentage of Participants

From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

ID	Title	Description
OG000	Placebo	Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
OG001	ASP0113 5mg	Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).

Units	Counts
Participants

Secondary

Percentage of Participants With Graft Survival (Primary Study Period)

Graft survival was defined for any participant that did not fit the definition of graft loss. Graft loss was defined as participant death, re-transplant, nephrectomy, or return to permanent dialysis (i.e., for > 30 days). Missing values for graft survival were not included in the denominator when making the proportion. The analysis population was the FAS.

The analysis population was the FAS, with data available.

Posted

Number

Percentage of Participants

From first study dose injection (day 1) up to one year post study drug injection (up to Day 380)

ID	Title	Description
OG000	Placebo	Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
OG001	ASP0113 5mg	Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).

Units	Counts
Participants

Secondary

Percentage of Participants With Graft Survival (Long-term Follow up)

All participants who entered long-term follow-up.

Posted

Number

Percentage of Participants

Month 18, 30, 42, 54, and 66

ID	Title	Description
OG000	Placebo	Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
OG001	ASP0113 5mg	Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG0012 events2 affected75 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected75 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected75 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected75 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Bradycardia	Cardiac disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Coronary artery disease	Cardiac disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Hyperparathyroidism tertiary	Endocrine disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Angle closure glaucoma	Eye disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Constipation	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0012 events2 affected75 at risk
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Subileus	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG0003 events1 affected74 at risk EG0010 events0 affected75 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected75 at risk
Malaise	General disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Pyrexia	General disorders	MedDRA v16.0	Systematic Assessment	EG0003 events3 affected74 at risk EG0013 events3 affected75 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Drug hypersensitivity	Immune system disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Kidney transplant rejection	Immune system disorders	MedDRA v16.0	Systematic Assessment	EG0004 events4 affected74 at risk EG0013 events3 affected75 at risk
Abscess soft tissue	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
BK virus infection	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0013 events2 affected75 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0002 events1 affected74 at risk EG0010 events0 affected75 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0002 events1 affected74 at risk EG0011 events1 affected75 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected75 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG0017 events7 affected75 at risk
Cytomegalovirus mucocutaneous ulcer	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0012 events1 affected75 at risk
Cytomegalovirus oesophagitis	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Cytomegalovirus syndrome	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0005 events5 affected74 at risk EG0012 events2 affected75 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0003 events3 affected74 at risk EG0017 events5 affected75 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Enterocolitis bacterial	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Epstein-Barr viraemia	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Escherichia sepsis	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG0016 events5 affected75 at risk
Gastroenteritis	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Gastroenteritis viral	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Gastrointestinal infection	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Haematoma infection	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Infected lymphocele	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Nasopharyngitis	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Orchitis	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Peritonitis	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Pneumonia	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected75 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0013 events3 affected75 at risk
Pneumonia necrotising	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Polyomavirus-associated nephropathy	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Pyelonephritis	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Pyelonephritis acute	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected75 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Urinary tract infection	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG0014 events2 affected75 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0014 events3 affected75 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected75 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Urosepsis	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0013 events3 affected75 at risk
Viral infection	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected75 at risk
Bone fissure	Injury, poisoning and procedural complications	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Graft haemorrhage	Injury, poisoning and procedural complications	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA v16.0	Systematic Assessment	EG0002 events1 affected74 at risk EG0010 events0 affected75 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Perinephric collection	Injury, poisoning and procedural complications	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0012 events1 affected75 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Wound	Injury, poisoning and procedural complications	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Blood creatinine increased	Investigations	MedDRA v16.0	Systematic Assessment	EG0004 events4 affected74 at risk EG0015 events5 affected75 at risk
Blood glucose increased	Investigations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
HLA marker study positive	Investigations	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Immunosuppressant drug level increased	Investigations	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0002 events1 affected74 at risk EG0010 events0 affected75 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected75 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG0011 events1 affected75 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0013 events2 affected75 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected75 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected75 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0012 events1 affected75 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected75 at risk
Convulsion	Nervous system disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Depression	Psychiatric disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Mental status changes	Psychiatric disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Calculus urinary	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Haematuria	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected75 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Nephropathy	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Renal cyst	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Renal failure acute	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG00010 events6 affected74 at risk EG00112 events10 affected75 at risk
Renal impairment	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected75 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Urinary bladder atrophy	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Urinary retention	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Urinary tract disorder	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Urinoma	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0012 events2 affected75 at risk
Nephrectomy	Surgical and medical procedures	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Transurethral prostatectomy	Surgical and medical procedures	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Ureteral stent removal	Surgical and medical procedures	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Urostomy	Surgical and medical procedures	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Aortic aneurysm	Vascular disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0010 events0 affected75 at risk
Deep vein thrombosis	Vascular disorders	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected75 at risk
Hypotension	Vascular disorders	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG0010 events0 affected75 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Lymphocele	Vascular disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0011 events1 affected75 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk
Thrombosis	Vascular disorders	MedDRA v16.0	Systematic Assessment	EG0000 events0 affected74 at risk EG0011 events1 affected75 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v16.0	Systematic Assessment	EG0004 events4 affected74 at risk EG0017 events7 affected75 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v16.0	Systematic Assessment	EG00023 events19 affected74 at risk EG00132 events29 affected75 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v16.0	Systematic Assessment	EG0006 events6 affected74 at risk EG00111 events10 affected75 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v16.0	Systematic Assessment	EG0006 events5 affected74 at risk EG0011 events1 affected75 at risk
Bradycardia	Cardiac disorders	MedDRA v16.0	Systematic Assessment	EG0003 events3 affected74 at risk EG0015 events5 affected75 at risk
Tachycardia	Cardiac disorders	MedDRA v16.0	Systematic Assessment	EG0003 events3 affected74 at risk EG0015 events5 affected75 at risk
Vision blurred	Eye disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0015 events5 affected75 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG0007 events6 affected74 at risk EG0019 events8 affected75 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG0003 events3 affected74 at risk EG0015 events5 affected75 at risk
Constipation	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG0007 events6 affected74 at risk EG0014 events4 affected75 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG00038 events24 affected74 at risk EG00133 events23 affected75 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG0003 events3 affected74 at risk EG0016 events5 affected75 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG0007 events6 affected74 at risk EG0011 events1 affected75 at risk
Nausea	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG00019 events14 affected74 at risk EG00122 events13 affected75 at risk
Vomiting	Gastrointestinal disorders	MedDRA v16.0	Systematic Assessment	EG00013 events9 affected74 at risk EG00112 events9 affected75 at risk
Asthenia	General disorders	MedDRA v16.0	Systematic Assessment	EG0008 events8 affected74 at risk EG0015 events5 affected75 at risk
Chills	General disorders	MedDRA v16.0	Systematic Assessment	EG0004 events4 affected74 at risk EG0012 events2 affected75 at risk
Fatigue	General disorders	MedDRA v16.0	Systematic Assessment	EG00038 events24 affected74 at risk EG00159 events27 affected75 at risk
Injection site erythema	General disorders	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG00114 events8 affected75 at risk
Injection site pain	General disorders	MedDRA v16.0	Systematic Assessment	EG00046 events18 affected74 at risk EG001277 events47 affected75 at risk
Oedema	General disorders	MedDRA v16.0	Systematic Assessment	EG0003 events3 affected74 at risk EG0015 events5 affected75 at risk
Oedema peripheral	General disorders	MedDRA v16.0	Systematic Assessment	EG0008 events5 affected74 at risk EG00113 events9 affected75 at risk
Pyrexia	General disorders	MedDRA v16.0	Systematic Assessment	EG00014 events13 affected74 at risk EG00111 events9 affected75 at risk
BK virus infection	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG00018 events16 affected74 at risk EG00117 events16 affected75 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0007 events5 affected74 at risk EG0014 events3 affected75 at risk
Cytomegalovirus syndrome	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0006 events6 affected74 at risk EG0017 events7 affected75 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG00022 events19 affected74 at risk EG00130 events22 affected75 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0005 events5 affected74 at risk EG0019 events6 affected75 at risk
Nasopharyngitis	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG00010 events8 affected74 at risk EG00110 events8 affected75 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0007 events7 affected74 at risk EG0019 events8 affected75 at risk
Urinary tract infection	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0005 events4 affected74 at risk EG00117 events10 affected75 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA v16.0	Systematic Assessment	EG0005 events3 affected74 at risk EG00111 events8 affected75 at risk
Complications of transplant surgery	Injury, poisoning and procedural complications	MedDRA v16.0	Systematic Assessment	EG0004 events4 affected74 at risk EG0012 events2 affected75 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA v16.0	Systematic Assessment	EG0004 events4 affected74 at risk EG0014 events4 affected75 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG00110 events6 affected75 at risk
Blood creatinine increased	Investigations	MedDRA v16.0	Systematic Assessment	EG00019 events16 affected74 at risk EG00117 events11 affected75 at risk
Weight increased	Investigations	MedDRA v16.0	Systematic Assessment	EG0003 events3 affected74 at risk EG0014 events4 affected75 at risk
White blood cell count decreased	Investigations	MedDRA v16.0	Systematic Assessment	EG00012 events4 affected74 at risk EG0011 events1 affected75 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0005 events5 affected74 at risk EG0013 events3 affected75 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0014 events4 affected75 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0005 events5 affected74 at risk EG0014 events4 affected75 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0006 events5 affected74 at risk EG0012 events2 affected75 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0008 events8 affected74 at risk EG00116 events12 affected75 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0003 events3 affected74 at risk EG0014 events4 affected75 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0007 events6 affected74 at risk EG0011 events1 affected75 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0006 events6 affected74 at risk EG00113 events7 affected75 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0017 events5 affected75 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0008 events7 affected74 at risk EG0018 events7 affected75 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0004 events4 affected74 at risk EG00112 events11 affected75 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA v16.0	Systematic Assessment	EG0004 events4 affected74 at risk EG0017 events7 affected75 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v16.0	Systematic Assessment	EG00010 events8 affected74 at risk EG0017 events5 affected75 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v16.0	Systematic Assessment	EG0009 events8 affected74 at risk EG0016 events5 affected75 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v16.0	Systematic Assessment	EG0006 events5 affected74 at risk EG0013 events3 affected75 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v16.0	Systematic Assessment	EG0004 events4 affected74 at risk EG0010 events0 affected75 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA v16.0	Systematic Assessment	EG0007 events6 affected74 at risk EG00111 events4 affected75 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG0014 events4 affected75 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v16.0	Systematic Assessment	EG00022 events15 affected74 at risk EG00138 events21 affected75 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v16.0	Systematic Assessment	EG0009 events8 affected74 at risk EG0015 events4 affected75 at risk
Dizziness	Nervous system disorders	MedDRA v16.0	Systematic Assessment	EG00012 events9 affected74 at risk EG0013 events3 affected75 at risk
Headache	Nervous system disorders	MedDRA v16.0	Systematic Assessment	EG00014 events12 affected74 at risk EG00113 events13 affected75 at risk
Tremor	Nervous system disorders	MedDRA v16.0	Systematic Assessment	EG0009 events7 affected74 at risk EG00111 events10 affected75 at risk
Insomnia	Psychiatric disorders	MedDRA v16.0	Systematic Assessment	EG0008 events6 affected74 at risk EG00111 events8 affected75 at risk
Dysuria	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0006 events6 affected74 at risk EG0015 events5 affected75 at risk
Haematuria	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0007 events7 affected74 at risk EG0018 events6 affected75 at risk
Kidney fibrosis	Renal and urinary disorders	MedDRA v16.0	Systematic Assessment	EG0004 events4 affected74 at risk EG0017 events7 affected75 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v16.0	Systematic Assessment	EG0004 events4 affected74 at risk EG0018 events7 affected75 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v16.0	Systematic Assessment	EG00010 events8 affected74 at risk EG0019 events5 affected75 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v16.0	Systematic Assessment	EG0005 events5 affected74 at risk EG0014 events4 affected75 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v16.0	Systematic Assessment	EG0009 events8 affected74 at risk EG0013 events3 affected75 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v16.0	Systematic Assessment	EG0002 events2 affected74 at risk EG0014 events4 affected75 at risk
Ureteral stent removal	Surgical and medical procedures	MedDRA v16.0	Systematic Assessment	EG0006 events6 affected74 at risk EG0011 events1 affected75 at risk
Arteriosclerosis	Vascular disorders	MedDRA v16.0	Systematic Assessment	EG0001 events1 affected74 at risk EG0014 events4 affected75 at risk
Hypertension	Vascular disorders	MedDRA v16.0	Systematic Assessment	EG00014 events9 affected74 at risk EG00112 events12 affected75 at risk
Hypotension	Vascular disorders	MedDRA v16.0	Systematic Assessment	EG00010 events8 affected74 at risk EG00116 events11 affected75 at risk
Orthostatic hypotension	Vascular disorders	MedDRA v16.0	Systematic Assessment	EG0005 events4 affected74 at risk EG0010 events0 affected75 at risk

ID	Title	Description
BG000	Placebo	Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
BG001	ASP0113	Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received 1 mL of 5 mg/mL of placebo via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	5	74	36	74	72	74
EG001	ASP0113	Participants received 1 mL of 5 mg/mL of ASP0113 via injection in the deltoid muscle alternating sides with each dose on days 30, 60, 90, 120 and 180 in relation to the day of transplant (Day 0).	7	75	44	75	75	75