Trial Outcomes & Findings for Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor (NCT NCT01567085)

Last Updated: 2019-05-03

Results Overview

Results are reported for post-transplantation treatment failure and composite endpoints, defined as the occurrence of biopsy-proven acute antibody-mediated rejection (AMR), graft loss, death, or loss to follow-up (including discontinuation) in the first 9 weeks post transplantation. The diagnosis of acute AMR (occurring within the first 9 weeks post transplantation) was based on kidney allograft dysfunction and a biopsy performed due to suspected rejection, proteinuria, increased serum creatinine, or acute tubular necrosis. Treatment failure was the occurrence of at least 1 of the composite endpoint components by Week 9 post transplantation. A participant experiencing multiple events was only counted once for the composite endpoint.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

Baseline, Week 9

Results posted on

2019-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	Eculizumab All eculizumab was administered intravenously (IV) over 25 to 45 minutes. Eculizumab 1200 milligrams (mg) was administered approximately 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.
Overall Study STARTED	80
Overall Study Received at Least 1 Dose of Study Drug	80
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Eculizumab All eculizumab was administered intravenously (IV) over 25 to 45 minutes. Eculizumab 1200 milligrams (mg) was administered approximately 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.
Overall Study Death	6
Overall Study Adverse Event	6
Overall Study Lost to Follow-up	3
Overall Study Graft loss	2
Overall Study Renal transplantectomy	1
Overall Study Returned to chronic dialysis	1
Overall Study Terminal chronic kidney dysfunction	1

Baseline Characteristics

Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Eculizumab n=80 Participants All eculizumab was administered IV over 25 to 45 minutes. Eculizumab 1200 mg was administered approximately 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.
Age, Continuous	50.7 years STANDARD_DEVIATION 11.26 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants
Race/Ethnicity, Customized White	59 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 9

Population: Full Analysis Population: participants who were enrolled, received a deceased donor kidney transplant, and received at least 1 dose of eculizumab.

Outcome measures

Outcome measures
Measure	Eculizumab n=80 Participants All eculizumab was administered IV over 25 to 45 minutes. Eculizumab 1200 mg was administered approximately 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.
Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation Treatment Failure - Yes	7 Participants
Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation Treatment Failure - No	73 Participants
Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation Biopsy-proven Acute AMR	3 Participants
Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation Graft Loss	4 Participants
Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation Death	1 Participants
Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation Lost to Follow-up (Including Discontinuation)	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 12

Population: Safety Population: enrolled participants who received at least 1 dose of eculizumab.

Specific analyses of other AEs of interest that occurred at Month 12 included cumulative incidence of clinically significant infection (CSI); post-transplant lymphoproliferative disease (PTLD); malignancies; biopsy-proven acute cellular rejection (ACR) of any grade meeting Banff 2007 criteria; allograft loss for reasons other than AMR. CSIs were defined as infections (confirmed by culture, biopsy, genomic, or serologic findings) that required hospitalization or anti-infective treatment, or otherwise deemed significant by the Investigator. CSI subcategories of interest included cytomegalovirus (CMV) disease; BK virus disease; encapsulated bacterial infection; fungal infections; aspergillus infections. Results are reported as CIF, where a larger CIF indicates a higher incidence of an AE, and were calculated using Statistical Analysis System software and macro CIF. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.

Outcome measures

Outcome measures
Measure	Eculizumab n=80 Participants All eculizumab was administered IV over 25 to 45 minutes. Eculizumab 1200 mg was administered approximately 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.
Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12 Confirmed CSI	0.7989 Proportion of Adverse Events Interval 0.69 to 0.87
Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12 CMV Infection	0.2994 Proportion of Adverse Events Interval 0.2 to 0.4
Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12 BK Virus Infection	0.1536 Proportion of Adverse Events Interval 0.08 to 0.24
Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12 Encapsulated Bacterial Infection	0.1642 Proportion of Adverse Events Interval 0.09 to 0.25
Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12 Fungal Infection	0.1287 Proportion of Adverse Events Interval 0.07 to 0.21
Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12 Aspergillus Infection	0 Proportion of Adverse Events Interval 0.0 to 0.0
Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12 PTLD	0.0264 Proportion of Adverse Events Interval 0.0 to 0.08
Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12 Malignancies	0.0264 Proportion of Adverse Events Interval 0.0 to 0.08
Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12 Biopsy-proven ACR	0.0375 Proportion of Adverse Events Interval 0.01 to 0.1
Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12 Allograft Loss For Reasons Other Than AMR	0.1132 Proportion of Adverse Events Interval 0.06 to 0.19

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 12

Population: Safety Population: participants who received at least 1 dose of eculizumab.

This outcome measure focuses on the other AE of interest, severe ACR, which occurred at Month 12. It pertains specifically to the number of participants who developed severe ACR that did not respond to thymoglobulin or other lymphocyte-depleting agents. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Outcome measures

Outcome measures
Measure	Eculizumab n=80 Participants All eculizumab was administered IV over 25 to 45 minutes. Eculizumab 1200 mg was administered approximately 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.
Participants That Developed Severe ACR (Other AE Of Interest) At Month 12	3 Participants

Adverse Events

Eculizumab

Serious events: 70 serious events

Other events: 80 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Eculizumab n=80 participants at risk All eculizumab was administered IV over 25 to 45 minutes. Eculizumab 1200 mg was administered approximately 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.
Blood and lymphatic system disorders Anaemia	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Blood and lymphatic system disorders Febrile neutropenia	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Blood and lymphatic system disorders Leukopenia	3.8% 3/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Blood and lymphatic system disorders Neutropenia	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Blood and lymphatic system disorders Pancytopenia	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Blood and lymphatic system disorders Thrombotic microangiopathy	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Cardiac disorders Angina pectoris	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Cardiac disorders Atrial fibrillation	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Cardiac disorders Atrioventricular block complete	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Cardiac disorders Myocardial ischaemia	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Cardiac disorders Supraventricular tachycardia	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Abdominal pain	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Ascites	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Colitis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Diarrhoea	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Gingivitis ulcerative	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Impaired gastric emptying	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Inguinal hernia	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Intestinal obstruction	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Intra-abdominal fluid collection	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Palatal disorder	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Pneumoperitoneum	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Rectal haemorrhage	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Small intestinal obstruction	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Small intestinal perforation	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Umbilical hernia	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
General disorders Catheter site pain	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
General disorders Chest pain	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
General disorders Multiple organ dysfunction syndrome	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
General disorders Non-cardiac chest pain	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
General disorders Pyrexia	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
General disorders Ulcer haemorrhage	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Hepatobiliary disorders Cholangitis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Hepatobiliary disorders Cholecystitis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Hepatobiliary disorders Cholecystitis acute	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Hepatobiliary disorders Cholelithiasis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Hepatobiliary disorders Drug-induced liver injury	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Hepatobiliary disorders Jaundice cholestatic	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Immune system disorders Drug hypersensitivity	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Immune system disorders Kidney transplant rejection	31.2% 25/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations BK virus infection	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Bacteraemia	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Bacterial pyelonephritis	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Bronchitis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Bronchitis viral	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Campylobacter infection	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Candiduria	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Catheter site infection	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Clostridium difficile colitis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Cytomegalovirus colitis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Cytomegalovirus infection	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Device related sepsis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Diarrhoea infectious	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Encephalitis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Enterococcal sepsis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Escherichia pyelonephritis	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Escherichia sepsis	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Escherichia urinary tract infection	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Gastroenteritis	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Gastroenteritis norovirus	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Gastroenteritis viral	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Gingival abscess	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Haematoma infection	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Hepatic cyst infection	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Hepatitis C	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Incision site infection	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Infected cyst	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Infected fistula	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Klebsiella infection	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Klebsiella sepsis	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Lung abscess	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Periodontitis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Pneumonia	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Pneumonia cryptococcal	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Polyomavirus-associated nephropathy	3.8% 3/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Pyelonephritis	8.8% 7/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Pyelonephritis acute	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Sepsis	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Septic shock	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Systemic mycosis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Tooth infection	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Upper respiratory tract infection	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Urinary tract infection	3.8% 3/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Urinary tract infection bacterial	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Urosepsis	3.8% 3/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Viral infection	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Accidental overdose	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	3.8% 3/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Complications of transplanted kidney	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Delayed graft function	12.5% 10/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Fall	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Incisional hernia	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Post procedural haematoma	3.8% 3/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Post procedural haematuria	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Post procedural haemorrhage	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Traumatic haematoma	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Urinary anastomotic leak	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Wound	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Investigations Antibody test positive	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Investigations Blood creatinine increased	7.5% 6/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Investigations White blood cell count increased	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Calciphylaxis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Dehydration	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Diabetes mellitus	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hypercalcaemia	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hyperkalaemia	3.8% 3/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hypoglycaemia	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hyponatraemia	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ductal adenocarcinoma of pancreas	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary thyroid cancer	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Refractory anaemia with an excess of blasts	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Nervous system disorders Disturbance in attention	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Nervous system disorders Headache	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Nervous system disorders Loss of consciousness	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Nervous system disorders Migraine	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Nervous system disorders Seizure	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Nervous system disorders Toxic encephalopathy	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	2.1% 1/48 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Pregnancy, puerperium and perinatal conditions Premature delivery	2.1% 1/48 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Acute kidney injury	15.0% 12/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Anuria	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Haematuria	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Hydronephrosis	3.8% 3/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Proteinuria	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Renal artery thrombosis	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Renal cyst	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Renal cyst haemorrhage	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Renal failure	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Renal haematoma	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Renal impairment	3.8% 3/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Renal tubular necrosis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Renal vascular thrombosis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Renal vein thrombosis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Urinoma	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Reproductive system and breast disorders Vaginal dysplasia	2.1% 1/48 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Skin and subcutaneous tissue disorders Skin ulcer	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Surgical and medical procedures Plastic surgery	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Vascular disorders Arterial disorder	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Vascular disorders Arteriovenous fistula	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Vascular disorders Deep vein thrombosis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Vascular disorders Hypertension	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Vascular disorders Hypotension	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Vascular disorders Lymphocele	2.5% 2/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Vascular disorders Peripheral artery thrombosis	1.2% 1/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.

Other adverse events

Other adverse events
Measure	Eculizumab n=80 participants at risk All eculizumab was administered IV over 25 to 45 minutes. Eculizumab 1200 mg was administered approximately 1 hour prior to kidney allograft reperfusion. Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days. Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.
Blood and lymphatic system disorders Anaemia	63.7% 51/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Blood and lymphatic system disorders Leukopenia	37.5% 30/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Blood and lymphatic system disorders Lymphopenia	13.8% 11/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Blood and lymphatic system disorders Neutropenia	22.5% 18/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Blood and lymphatic system disorders Pancytopenia	8.8% 7/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Blood and lymphatic system disorders Thrombocytopenia	15.0% 12/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Cardiac disorders Palpitations	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Cardiac disorders Tachycardia	7.5% 6/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Abdominal pain	17.5% 14/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Abdominal pain upper	11.2% 9/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Constipation	18.8% 15/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Diarrhoea	46.2% 37/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Gastrooesophageal reflux disease	15.0% 12/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Mouth ulceration	8.8% 7/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Nausea	31.2% 25/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Vomiting	22.5% 18/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
General disorders Asthenia	16.2% 13/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
General disorders Chest pain	8.8% 7/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
General disorders Influenza like illness	11.2% 9/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
General disorders Oedema	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
General disorders Oedema peripheral	38.8% 31/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
General disorders Pyrexia	25.0% 20/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Hepatobiliary disorders Cholestasis	7.5% 6/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Immune system disorders Hypogammaglobulinaemia	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Immune system disorders Kidney transplant rejection	27.5% 22/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations BK virus infection	12.5% 10/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Bacterial pyelonephritis	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Bronchitis	11.2% 9/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Conjunctivitis	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Escherichia infection	10.0% 8/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Escherichia urinary tract infection	10.0% 8/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Gastroenteritis	8.8% 7/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Gastroenteritis norovirus	7.5% 6/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Nasopharyngitis	13.8% 11/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Oral candidiasis	7.5% 6/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Pneumonia	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Polyomavirus-associated nephropathy	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Pyelonephritis	12.5% 10/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Upper respiratory tract infection	12.5% 10/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Urinary tract infection	40.0% 32/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Accidental overdose	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Complications of transplanted kidney	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Delayed graft function	15.0% 12/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Post procedural haematoma	7.5% 6/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Post procedural haemorrhage	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Procedural pain	13.8% 11/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Investigations Blood creatinine increased	18.8% 15/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Investigations Cardiac murmur	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Investigations Liver function test abnormal	10.0% 8/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Investigations Weight decreased	8.8% 7/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Investigations Weight increased	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Acidosis	26.2% 21/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Decreased appetite	7.5% 6/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Dehydration	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Diabetes mellitus	13.8% 11/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Fluid overload	11.2% 9/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hypercalcaemia	10.0% 8/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hyperglycaemia	17.5% 14/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hyperkalaemia	28.7% 23/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hyperphosphataemia	12.5% 10/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hypocalcaemia	17.5% 14/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hypoglycaemia	10.0% 8/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hypokalaemia	22.5% 18/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hypomagnesaemia	20.0% 16/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hyponatraemia	11.2% 9/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hypophosphataemia	13.8% 11/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Vitamin D deficiency	10.0% 8/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Musculoskeletal and connective tissue disorders Back pain	15.0% 12/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Musculoskeletal and connective tissue disorders Muscle spasms	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	23.8% 19/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Nervous system disorders Headache	27.5% 22/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Nervous system disorders Tremor	8.8% 7/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Psychiatric disorders Anxiety	11.2% 9/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Psychiatric disorders Insomnia	11.2% 9/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Acute kidney injury	12.5% 10/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Dysuria	10.0% 8/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Haematuria	13.8% 11/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Proteinuria	20.0% 16/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Renal impairment	11.2% 9/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Renal tubular necrosis	16.2% 13/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Urinary incontinence	10.0% 8/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	7.5% 6/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Respiratory, thoracic and mediastinal disorders Cough	22.5% 18/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Respiratory, thoracic and mediastinal disorders Dyspnoea	23.8% 19/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Respiratory, thoracic and mediastinal disorders Rales	7.5% 6/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Skin and subcutaneous tissue disorders Pruritus	10.0% 8/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Vascular disorders Deep vein thrombosis	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Vascular disorders Haematoma	7.5% 6/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Vascular disorders Hypertension	38.8% 31/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Vascular disorders Hypotension	16.2% 13/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Vascular disorders Lymphocele	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Vascular disorders Orthostatic hypotension	7.5% 6/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Cytomegalovirus infection	26.2% 21/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hypercholesterolaemia	7.5% 6/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Skin and subcutaneous tissue disorders Alopecia	6.2% 5/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Clostridium difficile infection	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Ear infection	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Enterococcal infection	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Escherichia pyelonephritis	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Herpex simplex	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Sinusitis	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Infections and infestations Urinary tract infection bacterial	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Cell death	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Metabolism and nutrition disorders Hyperlipidaemia	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Dyspepsia	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Gastritis	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Gastrointestinal disorders Haemorrhoids	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Oliguria	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Polyuria	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Renal and urinary disorders Renal artery stenosis	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
General disorders Pain	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Injury, poisoning and procedural complications Incisional hernia	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Respiratory, thoracic and mediastinal disorders Productive cough	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Nervous system disorders Dizziness	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Psychiatric disorders Depression	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.
Cardiac disorders Atrial fibrillation	5.0% 4/80 • Adverse event data were collected beginning on the day of transplantation, Day 0, through 12 months post transplantation.

Additional Information

Alexion Pharmaceuticals, Inc. (Sponsor)

Alexion Pharmaceuticals, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place