Prevention of Delayed Graft Function Using Eculizumab The... | NCT02145182

ID	Type	Description	Link
2013-004650-25	EudraCT Number

Name	Class
CTI Clinical Trial and Consulting Services	OTHER

Label	Type	Description	Intervention Names
Active	Experimental	Eculizumab was administered by intravenous (IV) infusion over 25-45 minutes (min) for 2 doses (on the day of transplant then 18-24 hours [h] later).	Drug: Eculizumab
Placebo	Placebo Comparator	Placebo was administered by IV infusion over 25-45 min for 2 doses (on the day of transplant then 18-24 h later).	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Eculizumab	Drug	Eculizumab is a complement component 5 inhibitor.	Active

Measure	Description	Time Frame
Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant	Results are reported for the DGF composite endpoint, defined as the occurrence of DGF (dialysis for any reason in the first 7 days post transplantation), graft loss, death, or loss to follow-up (including discontinuation) in the first 7 days post transplantation and for each item of the composite endpoint. Loss to follow-up included withdrawal due to any reason other than death. The sum of the counts in the events that make up the DGF composite may be greater than the composite count, because a participant who experienced multiple events was only counted once in the composite.	First 7 days post transplantation

Measure	Description	Time Frame
Percentage Of Participants With DGF, Functional DGF, And Immediate Graft Function	DGF was defined as a requirement for dialysis for any reason in the first 7 days post transplantation; functional DGF was defined as no need for dialysis during the first 7 days post transplantation and either (1) a <70% reduction in serum creatinine during the first 7 days post transplantation, or (2) failure of serum creatinine to decrease by at least 10% daily on 3 consecutive days, both measured during the first 7 days post transplantation. Blood and urine samples were collected, but because the study failed to demonstrate a treatment effect and the program subsequently lost funding, the collected data from the samples could not be analyzed to generate summary level data. As such, the data set for this secondary outcome measure cannot be summarized.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, 18 years or older
Has dialysis-dependent renal failure (initiated more than 2 months prior to transplant)
Participant is to receive a first kidney transplant from a standard criteria donor or expanded criteria donor deceased donor with a DGF risk score using the Irish scale of ≥25% (to be determined prior to surgery and before randomization)
Able to provide written informed consent
Willing and able to comply with the requirements of the study protocol
Female participants of child-bearing potential must have a negative serum pregnancy test (serum beta-human chorionic gonadotropin) and must be practicing an effective, reliable, and medically approved contraceptive regimen at the time of consent and for up to 5 months following discontinuation of treatment

Exclusion Criteria:

Participant to receive a multi-organ transplant
Participant to receive kidney(s) from donors <6 years of age
Participant to receive a dual kidney transplant (from same donor, including en bloc)
Participant to receive a living donor kidney
Participant is highly sensitized (high risk to develop acute antibody-mediated rejection) to the donor (as determined by local center practice). Testing to determine high risk may include but is not limited to flow cytometric cross match, single antigen bead testing and/or complement dependent cytotoxicity
Participant has received a previous transplant
Participant is participating in another investigational study
Participant has a body mass index >40 kilograms/square meter at screening
Participant will be the recipient of an A, B, O Blood Glycoproteins (ABO) (blood type) incompatible kidney (A2 donors to B and O recipients will be allowed if the site has the ability to confirm A2 subtype)
Participant will receive a kidney from a donation after cardiac death donor
Participant has a predicted Irish model risk of DGF <25%
Female participants who are pregnant or breast feeding
Female participants of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception
Participants with a history of human immunodeficiency virus, or active hepatitis C virus or hepatitis B virus infection
Participants with active bacterial or other infection which is clinically significant in the opinion of the Investigator
Participants with a history of splenectomy
Participants with unresolved meningococcal disease
Participants with an unresolved systemic bacterial or fungal infection
Participants with known or suspected hereditary complement deficiency (for example, but not limited to: atypical hemolytic uremic syndrome, paroxysmal nocturnal hemoglobinuria)
Participant has a current malignancy or a history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix that has been treated appropriately
Participant has a history of or is believed by the Investigator to have used an illicit drug(s) and/or abused alcohol within 3 months prior to screening
Participant has a psychiatric or physical illness that in the opinion of the Investigator would interfere with the ability of the participant to participate in the study

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35294	United States

ID	Title	Description
FG000	Eculizumab	Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 hours (h) of completion of administration of the first dose. Each dose of eculizumab was administered by intravenous (IV) infusion over 25 to 45 minutes (min). The first dose was 1200 milligrams (mg) in 240 milliliters (mL) (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).

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 Delayed Graft Function (DGF) In The First Seven Days Post-transplant

Results are reported for the DGF composite endpoint, defined as the occurrence of DGF (dialysis for any reason in the first 7 days post transplantation), graft loss, death, or loss to follow-up (including discontinuation) in the first 7 days post transplantation and for each item of the composite endpoint. Loss to follow-up included withdrawal due to any reason other than death. The sum of the counts in the events that make up the DGF composite may be greater than the composite count, because a participant who experienced multiple events was only counted once in the composite.

Full Analysis Set: all participants who were randomized to treatment and received a deceased donor kidney transplant and at least 1 dose of study drug (placebo or eculizumab).

Posted

Number

percentage of participants

First 7 days post transplantation

ID	Title	Description
OG000	Eculizumab	Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).
OG001	Placebo	Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.

Units	Counts
Participants	OG000142 OG001144

Title

Denominators

Categories

DGF Composite

Title	Measurements
	OG00035.9 OG00141.7

DGF

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	Analysis of DGF composite	Regression, Logistic	Logistic regression results for the DGF composite, the effect of treatment adjusted for preservation type, donor type, and Irish score.	0.3983		Odds Ratio (OR)	0.81			2-Sided	95	0.49	1.33			Calculated using the logistic regression model.		Superiority

Secondary

Percentage Of Participants With DGF, Functional DGF, And Immediate Graft Function

DGF was defined as a requirement for dialysis for any reason in the first 7 days post transplantation; functional DGF was defined as no need for dialysis during the first 7 days post transplantation and either (1) a <70% reduction in serum creatinine during the first 7 days post transplantation, or (2) failure of serum creatinine to decrease by at least 10% daily on 3 consecutive days, both measured during the first 7 days post transplantation. Blood and urine samples were collected, but because the study failed to demonstrate a treatment effect and the program subsequently lost funding, the collected data from the samples could not be analyzed to generate summary level data. As such, the data set for this secondary outcome measure cannot be summarized.

Full Analysis Set: all participants who were randomized to treatment and received a deceased donor kidney transplant and at least 1 dose of study drug (placebo or eculizumab). Because the study failed to demonstrate a treatment effect and the program subsequently lost funding, collected data could not be analyzed to generate summary level data.

Posted

First 7 days post transplantation

ID	Title	Description
OG000	Eculizumab	Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).

Secondary

Percentage Of Participants Who Required Dialysis Post Transplantation

The need for dialysis was assessed by evaluation of renal function; this included urine volume, blood urea nitrogen, serum creatinine, and, starting on Day 2, the creatinine reduction ratio. Blood and urine samples were collected, but because the study failed to demonstrate a treatment effect and the program subsequently lost funding, the collected data from the samples could not be analyzed to generate summary level data. As such, the data set for this secondary outcome measure cannot be summarized.

Posted

First 30 days post transplantation

ID	Title	Description
OG000	Eculizumab	Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).
OG001	Placebo	Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.

Secondary

Estimated Glomerular Filtration Rate (eGFR)

The eGFR was calculated by using the Modification of Diet in Renal Disease 7 equation at Day 28 post transplantation. The equation requires serum creatinine, age, ethnicity, gender, blood urea nitrogen, and albumin. The eGFR was calculated retrospectively from participant demographics and laboratory chemistries and is reported in mL/min/square meter (m^2).

Safety Set: all participants who received at least 1 dose of study drug (placebo or eculizumab) and made the Day 28 visit.

Posted

Mean

Standard Deviation

mL/min/1.73 m^2

Day 28 post transplantation

ID	Title	Description
OG000	Eculizumab	Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).
OG001	Placebo	Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.

Secondary

Percentage Of Participants With Rejection-free Graft Survival

Graft survival was defined as not having biopsy-proven acute rejection per Banff criteria, graft loss, or participant death. Participants who did not experience graft loss or death were censored at 365 days or the day they withdrew, whichever came first. There were no time-specific protocol mandated biopsies. Kidney biopsy would have been performed for cause at the discretion of the Investigator to assess poor graft function and would have been obtained prior to initiating treatment of suspected allograft rejection. Only summaries of Kaplan-Meier estimates of graft survival at Week 26 (Month 6) and Week 52 (Month 12) are reported.

Full Analysis Set: all participants who were randomized to treatment and received a deceased donor kidney transplant and at least 1 dose of study drug (placebo or eculizumab). Eculizumab participants censored: Month 6 = 7; Month 12 = 132. Placebo participants censored: Month 6 = 2; Month 12 = 128.

Posted

Number

95% Confidence Interval

percentage of participants

Week 26 and 52 post transplantation

ID	Title	Description
OG000	Eculizumab	Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).
OG001	Placebo

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0005 affected142 at risk EG0013 affected146 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0012 affected146 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0011 affected146 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0012 affected146 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0013 affected146 at risk
Angina unstable	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Arrhythmia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0011 affected146 at risk
Atrial flutter	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Cardiac arrest	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Cardiac failure	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0013 affected146 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0013 affected146 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Tachycardia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected142 at risk EG0011 affected146 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Anal fissure	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Constipation	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Internal hernia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Megacolon	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0010 affected146 at risk
Nausea	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0012 affected146 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0012 affected146 at risk
Asthenia	General disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0010 affected146 at risk
Chest pain	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Death	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
General physical health deterioration	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Generalised oedema	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Pyrexia	General disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected142 at risk EG0014 affected146 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Anaphylactic shock	Immune system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0010 affected146 at risk
Kidney transplant rejection	Immune system disorders	MedDRA (19.1)	Systematic Assessment	EG0004 affected142 at risk EG0013 affected146 at risk
Renal transplant failure	Immune system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Abdominal abscess	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Abdominal sepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Abscess limb	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Bacteraemia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Bacterial sepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0010 affected146 at risk
Bronchitis moraxella	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Cellulitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0010 affected146 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected142 at risk EG0012 affected146 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected142 at risk EG0013 affected146 at risk
Diabetic foot infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0013 affected146 at risk
Enterococcal infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Enterococcal sepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Epididymitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Escherichia infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Escherichia pyelonephritis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected142 at risk EG0011 affected146 at risk
Escherichia sepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected142 at risk EG0010 affected146 at risk
Gangrene	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0010 affected146 at risk
Gastroenteritis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Infected lymphocele	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Intervertebral discitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Klebsiella sepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Liver abscess	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Nocardiosis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Osteomyelitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0010 affected146 at risk
Peritonitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Pneumonia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0007 affected142 at risk EG0018 affected146 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0010 affected146 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Pneumonia viral	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Polyomavirus-associated nephropathy	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Postoperative wound infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0011 affected146 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Pyelonephritis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0012 affected146 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0014 affected146 at risk
Respiratory tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0011 affected146 at risk
Salmonella sepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Sepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0011 affected146 at risk
Septic shock	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 affected142 at risk EG0011 affected146 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Systemic candida	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0007 affected142 at risk EG0014 affected146 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 affected142 at risk EG0012 affected146 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Urosepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0006 affected142 at risk EG0013 affected146 at risk
Wound abscess	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0004 affected142 at risk EG0014 affected146 at risk
Delayed graft function	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Graft haemorrhage	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Graft loss	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Incision site haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Perinephric collection	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0012 affected146 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0013 affected146 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0011 affected146 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0012 affected146 at risk
Post procedural urine leak	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Transplant dysfunction	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0012 affected146 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Urinary anastomotic leak	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Wound decomposition	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Biopsy kidney abnormal	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Blood creatinine increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0003 affected142 at risk EG0012 affected146 at risk
Donor specific antibody present	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Liver function test abnormal	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Urine output decreased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0012 affected146 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Calciphylaxis	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0012 affected146 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0012 affected146 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0012 affected146 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0009 affected142 at risk EG0015 affected146 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0012 affected146 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0013 affected146 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Headache	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Hydrocephalus	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Loss of consciousness	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Neuromyopathy	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Neurotoxicity	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Seizure	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Somnolence	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Status epilepticus	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Syncope	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Tremor	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Bipolar disorder	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Confusional state	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Mental status changes	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0012 affected146 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected142 at risk EG0016 affected146 at risk
Anuria	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Azotaemia	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Haematuria	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0010 affected146 at risk
Mesangioproliferative glomerulonephritis	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0010 affected146 at risk
Obstructive nephropathy	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Renal artery dissection	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0013 affected146 at risk
Renal cyst haemorrhage	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Renal haematoma	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Renal impairment	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0013 affected146 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0012 affected146 at risk
Renal vein thrombosis	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0010 affected146 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0012 affected146 at risk
Urethral haemorrhage	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Urinary fistula	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Urinary retention	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Urinary tract disorder	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0012 affected146 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0013 affected146 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Mediastinal haematoma	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0011 affected146 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0012 affected146 at risk
Pulmonary haematoma	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0012 affected146 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0011 affected146 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 affected142 at risk EG0011 affected146 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Arteriovenous fistula	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0017 affected146 at risk
Haemorrhage	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Hypertension	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Hypertensive crisis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Hypotension	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0013 affected146 at risk
Lymphocele	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0011 affected146 at risk
Lymphorrhoea	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 affected142 at risk EG0010 affected146 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0002 affected142 at risk EG0010 affected146 at risk
Shock	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0012 affected146 at risk
Vena cava thrombosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 affected142 at risk EG0011 affected146 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00077 affected142 at risk EG00175 affected146 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0008 affected142 at risk EG0017 affected146 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00037 affected142 at risk EG00130 affected146 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00024 affected142 at risk EG00115 affected146 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0009 affected142 at risk EG00110 affected146 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG00017 affected142 at risk EG00112 affected146 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00013 affected142 at risk EG00114 affected146 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00040 affected142 at risk EG00140 affected146 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00037 affected142 at risk EG00135 affected146 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0009 affected142 at risk EG0018 affected146 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00036 affected142 at risk EG00132 affected146 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00030 affected142 at risk EG00124 affected146 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG00012 affected142 at risk EG00120 affected146 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0006 affected142 at risk EG00111 affected146 at risk
Oedema	General disorders	MedDRA	Systematic Assessment	EG0007 affected142 at risk EG0018 affected146 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG00041 affected142 at risk EG00157 affected146 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00026 affected142 at risk EG00120 affected146 at risk
Kidney transplant rejection	Immune system disorders	MedDRA	Systematic Assessment	EG00014 affected142 at risk EG0017 affected146 at risk
BK virus infection	Infections and infestations	MedDRA	Systematic Assessment	EG00018 affected142 at risk EG00118 affected146 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA	Systematic Assessment	EG00017 affected142 at risk EG00117 affected146 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected142 at risk EG00110 affected146 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00022 affected142 at risk EG00133 affected146 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00030 affected142 at risk EG00121 affected146 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG00014 affected142 at risk EG00121 affected146 at risk
Urine output decreased	Investigations	MedDRA	Systematic Assessment	EG0005 affected142 at risk EG00111 affected146 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00035 affected142 at risk EG00124 affected146 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 affected142 at risk EG0018 affected146 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00012 affected142 at risk EG0016 affected146 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00010 affected142 at risk EG00115 affected146 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00012 affected142 at risk EG00126 affected146 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00011 affected142 at risk EG0017 affected146 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00031 affected142 at risk EG00123 affected146 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00059 affected142 at risk EG00167 affected146 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00013 affected142 at risk EG00116 affected146 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00033 affected142 at risk EG00123 affected146 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0007 affected142 at risk EG00110 affected146 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00012 affected142 at risk EG00125 affected146 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00040 affected142 at risk EG00128 affected146 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0008 affected142 at risk EG00112 affected146 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00028 affected142 at risk EG00119 affected146 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0007 affected142 at risk EG0018 affected146 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00012 affected142 at risk EG0019 affected146 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00010 affected142 at risk EG00115 affected146 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 affected142 at risk EG00110 affected146 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00013 affected142 at risk EG00110 affected146 at risk
Tremor	Nervous system disorders	MedDRA	Systematic Assessment	EG00021 affected142 at risk EG00128 affected146 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG00010 affected142 at risk EG00110 affected146 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG00016 affected142 at risk EG00116 affected146 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0006 affected142 at risk EG00110 affected146 at risk
Bladder spasm	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0006 affected142 at risk EG0018 affected146 at risk
Dysuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00014 affected142 at risk EG00120 affected146 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00014 affected142 at risk EG00115 affected146 at risk
Proteinuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0008 affected142 at risk EG0016 affected146 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00015 affected142 at risk EG00110 affected146 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0008 affected142 at risk EG0015 affected146 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 affected142 at risk EG0019 affected146 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00010 affected142 at risk EG00110 affected146 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected142 at risk EG0019 affected146 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 affected142 at risk EG00110 affected146 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00011 affected142 at risk EG0019 affected146 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG00034 affected142 at risk EG00139 affected146 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG00029 affected142 at risk EG00133 affected146 at risk
Lymphocele	Vascular disorders	MedDRA	Systematic Assessment	EG0009 affected142 at risk EG0014 affected146 at risk

ID	Title	Description
BG000	Eculizumab	Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h after completion of administration of the first dose. Eculizumab was administered by IV infusion over 25 to 45 min for each dose. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).
BG001	Placebo	Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h after completion of administration of the first dose. Placebo was administered by IV infusion over 25 to 45 min for each dose. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
BG002	Total	Total of all reporting groups

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Eculizumab	Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).	8	142	92	142	139	142
EG001	Placebo	Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.	7	146	102	146	142	146