Safety & Efficacy of Eculizumab to Prevent AMR in Living... | NCT01399593

ID	Type	Description	Link
2010-019630-28	EudraCT Number
BB-IND: 100,003	Other Identifier	FDA IND: 100,003

Label	Type	Description	Intervention Names
Eculizumab	Experimental	Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously: the median infusion time was 39 minutes.	Drug: Eculizumab
Standard of Care	No Intervention	Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.

Name	Type	Description	Arm Group Labels	Other Names
Eculizumab	Drug		Eculizumab	Soliris

Measure	Description	Time Frame
Treatment Failure Rate	The primary efficacy variable was a binary outcome variable where patients meeting the composite endpoint of the occurrence of 1) biopsy-proven acute AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up definition at Week 9 post-transplantation were considered treatment failures and all others were considered treatment successes.	9 weeks post-transplantation

Name	Affiliation	Role
Masayo Ogawa, MD	Alexion Pharmaceuticals, Inc.	Study Director

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

PubMed Identifier	Type	Citation	Retractions
30887675	Derived	Marks WH, Mamode N, Montgomery RA, Stegall MD, Ratner LE, Cornell LD, Rowshani AT, Colvin RB, Dain B, Boice JA, Glotz D; C10-001 Study Group. Safety and efficacy of eculizumab in the prevention of antibody-mediated rejection in living-donor kidney transplant recipients requiring desensitization therapy: A randomized trial. Am J Transplant. 2019 Oct;19(10):2876-2888. doi: 10.1111/ajt.15364. Epub 2019 Apr 19.

ID	Title	Description
FG000	Eculizumab	Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9).
FG001	Standard of Care

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0012 affected51 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Microangiopathic haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0011 affected51 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Cardiac arrest	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0012 affected51 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Cardiac perforation	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Eye pain	Eye disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0003 affected51 at risk EG0018 affected51 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Mallory-Weiss Syndrome	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0012 affected51 at risk
Pancreatitis relapsing	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Subileus	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0011 affected51 at risk
Chest pain	General disorders	MedDRA 18.1	Non-systematic Assessment		EG0002 affected51 at risk EG0010 affected51 at risk
Hypothermia	General disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Impaired healing	General disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Influenza like illness	General disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Oedema peripheral	General disorders	MedDRA 18.1	Non-systematic Assessment		EG0002 affected51 at risk EG0010 affected51 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Kidney transplant rejection	Immune system disorders	MedDRA 18.1	Non-systematic Assessment		EG00022 affected51 at risk EG00128 affected51 at risk
Abdominal sepsis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	Fatality occurred in one patient who experienced both one serious adverse event of abdominal sepsis on Day 16 and one serious adverse event of bacterial sepsis on Day 36.	EG0001 affected51 at risk EG0010 affected51 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
BK virus infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Bacteraemia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Bacterial sepsis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	Fatality occurred in one patient who experienced both one serious adverse event of abdominal sepsis on Day 16 and one serious adverse event of bacterial sepsis on Day 36.	EG0001 affected51 at risk EG0010 affected51 at risk
Bronchiolitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Bronchitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0002 affected51 at risk EG0013 affected51 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Cellulitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0002 affected51 at risk EG0012 affected51 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Device related sepsis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0011 affected51 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Escherichia pyelonephritis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Escherichia sepsis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0011 affected51 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0004 affected51 at risk EG0016 affected51 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0014 affected51 at risk
Gastroenteritis cryptosporidial	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0011 affected51 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0012 affected51 at risk
Giardiasis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Haemophilus infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0011 affected51 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0002 affected51 at risk EG0010 affected51 at risk
Meningitis cryptococcal	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Metapneumovirus infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Otitis media	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0003 affected51 at risk EG0014 affected51 at risk
Pneumonia cryptococcal	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Pneumonia fungal	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Pneumonia viral	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Postoperative wound infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Pyelonephritis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0004 affected51 at risk EG0012 affected51 at risk
Renal abscess	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Sepsis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0011 affected51 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0002 affected51 at risk EG0017 affected51 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0002 affected51 at risk EG0011 affected51 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0012 affected51 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0011 affected51 at risk
Urinary tract infection staphylococcal	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Urosepsis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0004 affected51 at risk EG0012 affected51 at risk
Wound infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Ateriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Delayed graft function	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0002 affected51 at risk EG0011 affected51 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0002 affected51 at risk EG0011 affected51 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0012 affected51 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0013 affected51 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0012 affected51 at risk
Anti-glomerular basement membrane antibody	Investigations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Antibody test positive	Investigations	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Blood creatinine increased	Investigations	MedDRA 18.1	Non-systematic Assessment		EG0003 affected51 at risk EG0011 affected51 at risk
Drug level increased	Investigations	MedDRA 18.1	Non-systematic Assessment	High level of tacrolimus	EG0001 affected51 at risk EG0010 affected51 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Gout	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Dermatofibrosarcoma protuberans	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Post transplant lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Cerebellar haemorrhage	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Headache	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0012 affected51 at risk
Migraine	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment		EG0002 affected51 at risk EG0010 affected51 at risk
Seizure	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Spinal claudication	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Depression	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0002 affected51 at risk EG0013 affected51 at risk
Focal segmental glomerulosclerosis	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Haematuria	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0012 affected51 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0002 affected51 at risk EG0013 affected51 at risk
Nephrectasia	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Proteinuria	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Renal cyst	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Renal impairment	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Renal injury	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Ureteric dilatation	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Vesicoureteric reflux	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Convalescent	Social circumstances	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Nephrostomy	Surgical and medical procedures	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Circulatory collapse	Vascular disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.1	Non-systematic Assessment		EG0002 affected51 at risk EG0010 affected51 at risk
Hypertension	Vascular disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0011 affected51 at risk
Hypotension	Vascular disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Lymphocele	Vascular disorders	MedDRA 18.1	Non-systematic Assessment		EG0003 affected51 at risk EG0015 affected51 at risk
Superior vena cava occlusion	Vascular disorders	MedDRA 18.1	Non-systematic Assessment		EG0001 affected51 at risk EG0010 affected51 at risk
Venous thrombosis	Vascular disorders	MedDRA 18.1	Non-systematic Assessment		EG0000 affected51 at risk EG0011 affected51 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG00016 affected51 at risk EG00128 affected51 at risk
Hypofibrinogenaemia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected51 at risk EG0013 affected51 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG00016 affected51 at risk EG00123 affected51 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected51 at risk EG0015 affected51 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected51 at risk EG00112 affected51 at risk
Tachycardia	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0006 affected51 at risk EG00110 affected51 at risk
Vision blurred	Eye disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0011 affected51 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0009 affected51 at risk EG00113 affected51 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0011 affected51 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0013 affected51 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG00014 affected51 at risk EG00115 affected51 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG00022 affected51 at risk EG00127 affected51 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0012 affected51 at risk
Flatulence	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0014 affected51 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG0013 affected51 at risk
Localised intraabdominal fluid collection	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected51 at risk EG0013 affected51 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected51 at risk EG0013 affected51 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG00026 affected51 at risk EG00119 affected51 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG00013 affected51 at risk EG0017 affected51 at risk
Asthenia	General disorders	MedDRA 18.1	Non-systematic Assessment	EG00010 affected51 at risk EG00110 affected51 at risk
Chest pain	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0007 affected51 at risk EG0013 affected51 at risk
Chills	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected51 at risk EG0015 affected51 at risk
Influenza like illness	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected51 at risk EG0013 affected51 at risk
Malaise	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected51 at risk EG0013 affected51 at risk
Oedema	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG0015 affected51 at risk
Oedema peripheral	General disorders	MedDRA 18.1	Non-systematic Assessment	EG00015 affected51 at risk EG00121 affected51 at risk
Pain	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG0017 affected51 at risk
Pyrexia	General disorders	MedDRA 18.1	Non-systematic Assessment	EG00012 affected51 at risk EG00116 affected51 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG0013 affected51 at risk
Kidney transplant rejection	Immune system disorders	MedDRA 18.1	Non-systematic Assessment	EG00019 affected51 at risk EG00117 affected51 at risk
BK virus infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG00012 affected51 at risk EG0019 affected51 at risk
Bronchitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0012 affected51 at risk
Cellulitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0002 affected51 at risk EG0013 affected51 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0002 affected51 at risk EG0014 affected51 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0006 affected51 at risk EG0013 affected51 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0013 affected51 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG0010 affected51 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected51 at risk EG0013 affected51 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected51 at risk EG0018 affected51 at risk
Oral candidiasis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG0012 affected51 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0000 affected51 at risk EG0014 affected51 at risk
Respiratory tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0003 affected51 at risk EG0011 affected51 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG00013 affected51 at risk EG00111 affected51 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG00028 affected51 at risk EG00118 affected51 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG0011 affected51 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0010 affected51 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0003 affected51 at risk EG0011 affected51 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0008 affected51 at risk EG0016 affected51 at risk
Perinephric collection	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0003 affected51 at risk EG0011 affected51 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0003 affected51 at risk EG0011 affected51 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0007 affected51 at risk EG0018 affected51 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0002 affected51 at risk EG0016 affected51 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0000 affected51 at risk EG0014 affected51 at risk
Antibody test positive	Investigations	MedDRA 18.1	Non-systematic Assessment	EG0003 affected51 at risk EG0010 affected51 at risk
Blood creatinine increased	Investigations	MedDRA 18.1	Non-systematic Assessment	EG0009 affected51 at risk EG00112 affected51 at risk
Liver function test abnormal	Investigations	MedDRA 18.1	Non-systematic Assessment	EG0007 affected51 at risk EG0015 affected51 at risk
Weight decreased	Investigations	MedDRA 18.1	Non-systematic Assessment	EG0002 affected51 at risk EG0013 affected51 at risk
Weight increased	Investigations	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG0014 affected51 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected51 at risk EG0013 affected51 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0006 affected51 at risk EG0014 affected51 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected51 at risk EG0014 affected51 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0019 affected51 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG0012 affected51 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0016 affected51 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 affected51 at risk EG0015 affected51 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG00014 affected51 at risk EG00116 affected51 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG00010 affected51 at risk EG00115 affected51 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0011 affected51 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 affected51 at risk EG0014 affected51 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG00014 affected51 at risk EG00113 affected51 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG00011 affected51 at risk EG00110 affected51 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG00013 affected51 at risk EG00113 affected51 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0006 affected51 at risk EG0012 affected51 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG00016 affected51 at risk EG00112 affected51 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG00012 affected51 at risk EG00110 affected51 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0008 affected51 at risk EG0016 affected51 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0006 affected51 at risk EG00110 affected51 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected51 at risk EG0013 affected51 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG00011 affected51 at risk EG0018 affected51 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0011 affected51 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 affected51 at risk EG0012 affected51 at risk
Dizziness	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0007 affected51 at risk EG0016 affected51 at risk
Headache	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG00014 affected51 at risk EG0019 affected51 at risk
Migraine	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0012 affected51 at risk
Tremor	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG00014 affected51 at risk EG00114 affected51 at risk
Anxiety	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0008 affected51 at risk EG0016 affected51 at risk
Depression	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected51 at risk EG0013 affected51 at risk
Insomnia	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0007 affected51 at risk EG00111 affected51 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0013 affected51 at risk
Anuria	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected51 at risk EG0014 affected51 at risk
Bladder spasm	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 affected51 at risk EG0012 affected51 at risk
Dysuria	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 affected51 at risk EG0014 affected51 at risk
Haematuria	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG00110 affected51 at risk
Nocturia	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 affected51 at risk EG0010 affected51 at risk
Oliguria	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected51 at risk EG0016 affected51 at risk
Polyuria	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0006 affected51 at risk EG0014 affected51 at risk
Proteinuria	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0009 affected51 at risk EG0016 affected51 at risk
Renal impairment	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0012 affected51 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected51 at risk EG0014 affected51 at risk
Urinary retention	Renal and urinary disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected51 at risk EG0013 affected51 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 affected51 at risk EG0012 affected51 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG0016 affected51 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG0016 affected51 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected51 at risk EG0013 affected51 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0000 affected51 at risk EG0013 affected51 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG0019 affected51 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0009 affected51 at risk EG0019 affected51 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0005 affected51 at risk EG0013 affected51 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected51 at risk EG0011 affected51 at risk
Haematoma	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected51 at risk EG0013 affected51 at risk
Hypertension	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG00013 affected51 at risk EG00115 affected51 at risk
Hypotension	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0008 affected51 at risk EG00111 affected51 at risk
Lymphocele	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0003 affected51 at risk EG0013 affected51 at risk

ID	Title	Description
BG000	Eculizumab	Patients in the eculizumab treatment group were to receive eculizumab for 9 weeks according to the following dosing regimen: Eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.
BG001	Standard of Care (SOC)	Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
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	Eculizumab	Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.	1	51	43	51	51	51
EG001	Standard of Care	Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.	1	51	48	51	51	51