Trial Outcomes & Findings for Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study) (NCT NCT02145182)

NCT ID: NCT02145182

Last Updated: 2018-12-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 288 participants
• Primary outcome timeframe: First 7 days post transplantation
• Results posted on: 2018-12-17

Participant Flow

Fifty-nine centers in Australia, Brazil, Canada, Czech Republic, France, Germany, Italy, Spain, and the United States of America participated in this study. The study recruited participants who had been receiving dialysis for a median of approximately 50 months before undergoing transplantation and received a kidney from a deceased donor.

Written consent was provided prior to study-required assessments (N=333). Participants who passed screening (N=314) were vaccinated against Neisseria meningitidis. A total of 314 were randomized; of these, 286 underwent transplantation and received eculizumab or placebo. Two participants received placebo but withdrew prior to transplantation.

Participant milestones

Measure	Eculizumab Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 hours (h) of completion of administration of the first dose. Each dose of eculizumab was administered by intravenous (IV) infusion over 25 to 45 minutes (min). The first dose was 1200 milligrams (mg) in 240 milliliters (mL) (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).	Placebo Participants received 2 doses of placebo (0.9% sodium chloride \[NaCl\]): the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
Overall Study STARTED	142	146
Overall Study Received at Least 1 Dose of Study Drug	142	146
Overall Study COMPLETED	124	130
Overall Study NOT COMPLETED	18	16

Reasons for withdrawal

Measure	Eculizumab Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 hours (h) of completion of administration of the first dose. Each dose of eculizumab was administered by intravenous (IV) infusion over 25 to 45 minutes (min). The first dose was 1200 milligrams (mg) in 240 milliliters (mL) (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).	Placebo Participants received 2 doses of placebo (0.9% sodium chloride \[NaCl\]): the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
Overall Study Adverse Event	4	1
Overall Study Death	7	7
Overall Study Lost to Follow-up	2	2
Overall Study Pre-transplant Withdrawal	0	2
Overall Study Withdrawal by Subject	5	4

Baseline Characteristics

Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)

Baseline characteristics by cohort

Measure	Total n=288 Participants Total of all reporting groups	Eculizumab n=142 Participants Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h after completion of administration of the first dose. Eculizumab was administered by IV infusion over 25 to 45 min for each dose. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).	Placebo n=146 Participants Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h after completion of administration of the first dose. Placebo was administered by IV infusion over 25 to 45 min for each dose. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
Age, Continuous	57.3 years STANDARD_DEVIATION 12.65 • n=5 Participants	57.5 years STANDARD_DEVIATION 12.29 • n=5 Participants	57.1 years STANDARD_DEVIATION 13.03 • n=7 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	47 Participants n=5 Participants	45 Participants n=7 Participants
Sex: Female, Male Male	196 Participants n=5 Participants	95 Participants n=5 Participants	101 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants n=5 Participants	23 Participants n=5 Participants	23 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	221 Participants n=5 Participants	108 Participants n=5 Participants	113 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants	11 Participants n=5 Participants	10 Participants n=7 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	3 Participants n=5 Participants	1 Participants n=5 Participants	2 Participants n=7 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	0 Participants n=5 Participants	4 Participants n=7 Participants
Race/Ethnicity, Customized Black or African American	75 Participants n=5 Participants	38 Participants n=5 Participants	37 Participants n=7 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=5 Participants	0 Participants n=7 Participants
Race/Ethnicity, Customized White	180 Participants n=5 Participants	88 Participants n=5 Participants	92 Participants n=7 Participants
Race/Ethnicity, Customized Other	16 Participants n=5 Participants	9 Participants n=5 Participants	7 Participants n=7 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=5 Participants	1 Participants n=5 Participants	1 Participants n=7 Participants
Race/Ethnicity, Customized Unknown	7 Participants n=5 Participants	4 Participants n=5 Participants	3 Participants n=7 Participants

PRIMARY outcome

Timeframe: First 7 days post transplantation

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

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

Outcome measures

Measure	Eculizumab n=142 Participants Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).	Placebo n=144 Participants Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant DGF	33.8 percentage of participants	39.6 percentage of participants
Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant DGF Composite	35.9 percentage of participants	41.7 percentage of participants
Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant Death	0.0 percentage of participants	1.4 percentage of participants
Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant Graft Loss	0.7 percentage of participants	3.5 percentage of participants
Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant Lost to Follow-up (including discontinuation)	3.5 percentage of participants	1.4 percentage of participants

SECONDARY outcome

Timeframe: First 7 days post transplantation

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First 30 days post transplantation

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 28 post transplantation

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

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

Outcome measures

Measure	Eculizumab n=132 Participants Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).	Placebo n=135 Participants Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
Estimated Glomerular Filtration Rate (eGFR)	42.640 mL/min/1.73 m^2 Standard Deviation 20.7491	39.954 mL/min/1.73 m^2 Standard Deviation 20.3288

SECONDARY outcome

Timeframe: Week 26 and 52 post transplantation

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

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

Outcome measures

Measure	Eculizumab n=142 Participants Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).	Placebo n=144 Participants Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
Percentage Of Participants With Rejection-free Graft Survival Graft Survival at Month 6	94.89 percentage of participants Interval 89.58 to 97.53	90.96 percentage of participants Interval 84.94 to 94.65
Percentage Of Participants With Rejection-free Graft Survival Graft Survival at Month 12	92.66 percentage of participants Interval 86.78 to 95.98	88.69 percentage of participants Interval 82.17 to 92.92

Adverse Events

Eculizumab

Serious events: 92 serious events

Other events: 139 other events

Deaths: 8 deaths

Placebo

Serious events: 102 serious events

Other events: 142 other events

Deaths: 7 deaths

Serious adverse events

Measure	Eculizumab n=142 participants at risk Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).	Placebo n=146 participants at risk Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
Immune system disorders Renal transplant failure	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Abdominal abscess	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Abdominal sepsis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Abscess limb	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Bacteraemia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Bacterial pyelonephritis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Bacterial sepsis	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Bronchitis moraxella	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Cellulitis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Clostridium difficile colitis	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Clostridium difficile infection	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Cytomegalovirus infection	2.1% 3/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Cytomegalovirus viraemia	2.1% 3/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Diabetic foot infection	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Enterococcal bacteraemia	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Enterococcal infection	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Enterococcal sepsis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Epididymitis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Escherichia bacteraemia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Escherichia infection	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Escherichia pyelonephritis	2.1% 3/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Escherichia sepsis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Escherichia urinary tract infection	2.1% 3/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Gangrene	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Gastroenteritis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Infected lymphocele	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Infection	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Intervertebral discitis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Klebsiella bacteraemia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Klebsiella sepsis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Blood and lymphatic system disorders Anaemia	3.5% 5/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Blood and lymphatic system disorders Leukopenia	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Blood and lymphatic system disorders Pancytopenia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Blood and lymphatic system disorders Thrombocytopenia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Acute coronary syndrome	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Acute myocardial infarction	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Angina unstable	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Arrhythmia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Atrial fibrillation	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Atrial flutter	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Cardiac arrest	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Cardiac failure	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Cardiac failure congestive	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Myocardial ischaemia	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Tachycardia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Ventricular fibrillation	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Ventricular tachycardia	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Endocrine disorders Hyperparathyroidism	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Endocrine disorders Hyperparathyroidism secondary	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Abdominal hernia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Abdominal pain	2.1% 3/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Abdominal pain lower	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Anal fissure	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Anal ulcer	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Chronic gastritis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Constipation	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Diarrhoea	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Dyspepsia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Gastrointestinal disorder	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Gastrointestinal obstruction	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Haematochezia	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Ileal perforation	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Inguinal hernia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Internal hernia	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Intra-abdominal fluid collection	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Megacolon	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Mouth ulceration	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Nausea	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Oesophageal ulcer	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Pancreatitis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Vomiting	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
General disorders Asthenia	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
General disorders Chest pain	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
General disorders Death	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
General disorders General physical health deterioration	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
General disorders Generalised oedema	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
General disorders Pyrexia	2.8% 4/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.7% 4/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Hepatobiliary disorders Cholecystitis acute	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Hepatobiliary disorders Gallbladder perforation	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Immune system disorders Anaphylactic shock	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Immune system disorders Drug hypersensitivity	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Immune system disorders Kidney transplant rejection	2.8% 4/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Liver abscess	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Nocardiosis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Oesophageal candidiasis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Osteomyelitis	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Peritonitis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Pneumocystis jirovecii pneumonia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Pneumonia	4.9% 7/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	5.5% 8/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Pneumonia cytomegaloviral	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Pneumonia mycoplasmal	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Pneumonia pneumococcal	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Pneumonia viral	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Polyomavirus-associated nephropathy	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Postoperative wound infection	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Pseudomonal bacteraemia	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Pseudomonal sepsis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Pyelonephritis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Pyelonephritis acute	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.7% 4/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Respiratory tract infection	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Salmonella sepsis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Sepsis	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Septic shock	2.8% 4/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Staphylococcal sepsis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Systemic candida	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Upper respiratory tract infection	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Urinary tract infection	4.9% 7/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.7% 4/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Urinary tract infection bacterial	2.1% 3/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Urinary tract infection enterococcal	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Urosepsis	4.2% 6/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Wound abscess	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Complications of transplanted kidney	2.8% 4/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.7% 4/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Delayed graft function	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Graft haemorrhage	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Graft loss	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Graft thrombosis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Incision site haematoma	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Perinephric collection	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Perirenal haematoma	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Post procedural haematoma	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Post procedural haematuria	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Post procedural urine leak	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Procedural haemorrhage	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Procedural hypotension	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Seroma	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Toxicity to various agents	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Transplant dysfunction	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Ulna fracture	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Urinary anastomotic leak	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Wound decomposition	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Wound evisceration	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Investigations Biopsy kidney abnormal	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Investigations Blood creatinine increased	2.1% 3/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Investigations Donor specific antibody present	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Investigations Liver function test abnormal	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Investigations Urine output decreased	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Acidosis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Calciphylaxis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Decreased appetite	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Dehydration	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Diabetes mellitus	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hypercalcaemia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hyperkalaemia	6.3% 9/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	3.4% 5/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hypovolaemia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Musculoskeletal and connective tissue disorders Polyarthritis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Cerebrovascular accident	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Haemorrhage intracranial	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Headache	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Hydrocephalus	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Loss of consciousness	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Neuromyopathy	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Neurotoxicity	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Seizure	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Somnolence	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Status epilepticus	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Syncope	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Tremor	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Psychiatric disorders Bipolar disorder	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Psychiatric disorders Confusional state	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Psychiatric disorders Mental status changes	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Acute kidney injury	2.1% 3/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	4.1% 6/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Anuria	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Azotaemia	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Bladder outlet obstruction	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Haematuria	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Hydronephrosis	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Mesangioproliferative glomerulonephritis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Nephrolithiasis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Nephropathy toxic	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Obstructive nephropathy	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Renal artery dissection	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Renal artery stenosis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Renal cyst haemorrhage	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Renal haematoma	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Renal impairment	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Renal tubular necrosis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Renal vein thrombosis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Ureteric obstruction	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Ureteric stenosis	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Urethral haemorrhage	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Urinary fistula	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Urinary retention	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Urinary tract disorder	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Mediastinal haematoma	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Pulmonary haematoma	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.1% 3/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Skin and subcutaneous tissue disorders Angioedema	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Skin and subcutaneous tissue disorders Diabetic foot	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Arteriovenous fistula	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Deep vein thrombosis	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	4.8% 7/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Haemorrhage	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Hypertension	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Hypertensive crisis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Hypotension	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.1% 3/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Lymphocele	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Lymphorrhoea	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Peripheral ischaemia	1.4% 2/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.00% 0/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Shock	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	1.4% 2/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Vena cava thrombosis	0.00% 0/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	0.68% 1/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.

Other adverse events

Measure	Eculizumab n=142 participants at risk Participants received 2 doses of eculizumab: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of eculizumab was administered by IV infusion over 25 to 45 min. The first dose was 1200 mg in 240 mL (5 mg/mL); the second dose was 900 mg in 180 mL (5 mg/mL).	Placebo n=146 participants at risk Participants received 2 doses of placebo: the first dose was just prior to reperfusion of the allograft and the second dose was within 18 to 24 h of completion of administration of the first dose. Each dose of placebo was administered by IV infusion over 25 to 45 min. The first dose was 240 mL of 0.9% NaCl; the second dose was 180 mL of 0.9% NaCl.
Blood and lymphatic system disorders Anaemia	54.2% 77/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	51.4% 75/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Blood and lymphatic system disorders Leukocytosis	5.6% 8/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	4.8% 7/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Blood and lymphatic system disorders Leukopenia	26.1% 37/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	20.5% 30/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Blood and lymphatic system disorders Thrombocytopenia	16.9% 24/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	10.3% 15/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Atrial fibrillation	6.3% 9/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.8% 10/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Cardiac disorders Tachycardia	12.0% 17/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	8.2% 12/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Abdominal pain	9.2% 13/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	9.6% 14/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Constipation	28.2% 40/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	27.4% 40/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Diarrhoea	26.1% 37/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	24.0% 35/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Dyspepsia	6.3% 9/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	5.5% 8/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Nausea	25.4% 36/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	21.9% 32/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Gastrointestinal disorders Vomiting	21.1% 30/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	16.4% 24/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
General disorders Asthenia	8.5% 12/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	13.7% 20/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
General disorders Chest pain	4.2% 6/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	7.5% 11/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
General disorders Oedema	4.9% 7/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	5.5% 8/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
General disorders Oedema peripheral	28.9% 41/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	39.0% 57/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
General disorders Pyrexia	18.3% 26/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	13.7% 20/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Immune system disorders Kidney transplant rejection	9.9% 14/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	4.8% 7/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations BK virus infection	12.7% 18/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	12.3% 18/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Cytomegalovirus infection	12.0% 17/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	11.6% 17/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Upper respiratory tract infection	2.8% 4/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.8% 10/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Infections and infestations Urinary tract infection	15.5% 22/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	22.6% 33/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Injury, poisoning and procedural complications Procedural pain	21.1% 30/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	14.4% 21/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Investigations Blood creatinine increased	9.9% 14/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	14.4% 21/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Investigations Urine output decreased	3.5% 5/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	7.5% 11/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Acidosis	24.6% 35/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	16.4% 24/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Decreased appetite	2.1% 3/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	5.5% 8/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Diabetes mellitus	8.5% 12/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	4.1% 6/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	7.0% 10/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	10.3% 15/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Fluid overload	8.5% 12/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	17.8% 26/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hypercalcaemia	7.7% 11/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	4.8% 7/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hyperglycaemia	21.8% 31/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	15.8% 23/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hyperkalaemia	41.5% 59/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	45.9% 67/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hyperphosphataemia	9.2% 13/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	11.0% 16/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hypocalcaemia	23.2% 33/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	15.8% 23/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hypoglycaemia	4.9% 7/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.8% 10/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hypokalaemia	8.5% 12/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	17.1% 25/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hypomagnesaemia	28.2% 40/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	19.2% 28/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hyponatraemia	5.6% 8/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	8.2% 12/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Hypophosphataemia	19.7% 28/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	13.0% 19/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Metabolism and nutrition disorders Vitamin D deficiency	4.9% 7/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	5.5% 8/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Musculoskeletal and connective tissue disorders Back pain	8.5% 12/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.2% 9/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	7.0% 10/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	10.3% 15/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Dizziness	3.5% 5/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.8% 10/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Headache	9.2% 13/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.8% 10/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Nervous system disorders Tremor	14.8% 21/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	19.2% 28/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Psychiatric disorders Anxiety	7.0% 10/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.8% 10/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Psychiatric disorders Insomnia	11.3% 16/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	11.0% 16/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Acute kidney injury	4.2% 6/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.8% 10/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Bladder spasm	4.2% 6/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	5.5% 8/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Dysuria	9.9% 14/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	13.7% 20/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Haematuria	9.9% 14/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	10.3% 15/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Proteinuria	5.6% 8/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	4.1% 6/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Renal tubular necrosis	10.6% 15/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.8% 10/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Renal and urinary disorders Urinary retention	5.6% 8/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	3.4% 5/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Cough	4.2% 6/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.2% 9/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.0% 10/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.8% 10/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.70% 1/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.2% 9/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.5% 5/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.8% 10/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Skin and subcutaneous tissue disorders Pruritus	7.7% 11/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	6.2% 9/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Hypertension	23.9% 34/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	26.7% 39/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Hypotension	20.4% 29/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	22.6% 33/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.
Vascular disorders Lymphocele	6.3% 9/142 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.	2.7% 4/146 • Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.

Additional Information

Alexion Pharmaceuticals, Inc.

Alexion Pharmaceuticals, Inc.

Email: clinicaltrials@alexion.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place