Trial Outcomes & Findings for Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx (NCT NCT01187953)

NCT ID: NCT01187953

Last Updated: 2016-05-18

Results Overview

Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period: death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 543 participants
• Primary outcome timeframe: 360 days
• Results posted on: 2016-05-18

Participant Flow

Participant milestones

Measure	LCP-Tacro The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.	Prograf (Tacrolimus) Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study. Prograf (tacrolimus): Administered per current product labeling
Overall Study STARTED	268	275
Overall Study Dosed	266	271
Overall Study COMPLETED	253	254
Overall Study NOT COMPLETED	15	21

Reasons for withdrawal

Measure	LCP-Tacro The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.	Prograf (Tacrolimus) Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study. Prograf (tacrolimus): Administered per current product labeling
Overall Study Death	11	13
Overall Study Adverse Event	1	2
Overall Study Lost to Follow-up	0	3
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx

Baseline characteristics by cohort

Measure	LCP-Tacro n=268 Participants The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.	Prograf (Tacrolimus) n=275 Participants Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study. Prograf (tacrolimus): Administered per current product labeling	Total n=543 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	252 Participants n=93 Participants	247 Participants n=4 Participants	499 Participants n=27 Participants
Age, Categorical >=65 years	16 Participants n=93 Participants	28 Participants n=4 Participants	44 Participants n=27 Participants
Age, Continuous	44.8 years STANDARD_DEVIATION 13.29 • n=93 Participants	46.9 years STANDARD_DEVIATION 14.26 • n=4 Participants	45.8 years STANDARD_DEVIATION 13.82 • n=27 Participants
Sex: Female, Male Female	94 Participants n=93 Participants	94 Participants n=4 Participants	188 Participants n=27 Participants
Sex: Female, Male Male	174 Participants n=93 Participants	181 Participants n=4 Participants	355 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	74 Participants n=93 Participants	79 Participants n=4 Participants	153 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	194 Participants n=93 Participants	196 Participants n=4 Participants	390 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Black or African American	10 Participants n=93 Participants	15 Participants n=4 Participants	25 Participants n=27 Participants
Race (NIH/OMB) White	203 Participants n=93 Participants	214 Participants n=4 Participants	417 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	44 Participants n=93 Participants	34 Participants n=4 Participants	78 Participants n=27 Participants
Region of Enrollment Argentina	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants
Region of Enrollment Singapore	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants
Region of Enrollment United States	67 participants n=93 Participants	70 participants n=4 Participants	137 participants n=27 Participants
Region of Enrollment Spain	24 participants n=93 Participants	21 participants n=4 Participants	45 participants n=27 Participants
Region of Enrollment New Zealand	2 participants n=93 Participants	3 participants n=4 Participants	5 participants n=27 Participants
Region of Enrollment Poland	27 participants n=93 Participants	26 participants n=4 Participants	53 participants n=27 Participants
Region of Enrollment Brazil	29 participants n=93 Participants	29 participants n=4 Participants	58 participants n=27 Participants
Region of Enrollment Mexico	27 participants n=93 Participants	29 participants n=4 Participants	56 participants n=27 Participants
Region of Enrollment Italy	6 participants n=93 Participants	6 participants n=4 Participants	12 participants n=27 Participants
Region of Enrollment Australia	11 participants n=93 Participants	11 participants n=4 Participants	22 participants n=27 Participants
Region of Enrollment France	35 participants n=93 Participants	38 participants n=4 Participants	73 participants n=27 Participants
Region of Enrollment Serbia	6 participants n=93 Participants	5 participants n=4 Participants	11 participants n=27 Participants
Region of Enrollment Germany	32 participants n=93 Participants	35 participants n=4 Participants	67 participants n=27 Participants
Body Mass Index	25.72 kg/m^2 STANDARD_DEVIATION 4.648 • n=93 Participants	26.68 kg/m^2 STANDARD_DEVIATION 4.948 • n=4 Participants	26.21 kg/m^2 STANDARD_DEVIATION 4.822 • n=27 Participants
Diabetes at the time of transplant Patients with diabetes at transplant	50 participants n=93 Participants	56 participants n=4 Participants	106 participants n=27 Participants
Diabetes at the time of transplant Patients without diabetes at transplant	218 participants n=93 Participants	219 participants n=4 Participants	437 participants n=27 Participants
Time from transplant to first dose	34.15 hours STANDARD_DEVIATION 8.878 • n=93 Participants	34.38 hours STANDARD_DEVIATION 9.735 • n=4 Participants	34.27 hours STANDARD_DEVIATION 9.312 • n=27 Participants
Donor Type Living	135 participants n=93 Participants	129 participants n=4 Participants	264 participants n=27 Participants
Donor Type Deceased	133 participants n=93 Participants	145 participants n=4 Participants	278 participants n=27 Participants
Donor Type Missing	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants

PRIMARY outcome

Timeframe: 360 days

Population: All 543 randomized patients were included in the analysis population.

Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period: death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.

Outcome measures

Measure	LCP-Tacro n=268 Participants The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.	Prograf (Tacrolimus) n=275 Participants Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study. Prograf (tacrolimus): Administered per current product labeling
The Primary Efficacy Endpoint for the Study is the Proportion of Treatment Failures Within 12 Months After Randomization to Study Drug. Death	8 participants	8 participants
The Primary Efficacy Endpoint for the Study is the Proportion of Treatment Failures Within 12 Months After Randomization to Study Drug. Graft Failure	9 participants	11 participants
The Primary Efficacy Endpoint for the Study is the Proportion of Treatment Failures Within 12 Months After Randomization to Study Drug. Biobsy Proven Acute Rejection	35 participants	37 participants
The Primary Efficacy Endpoint for the Study is the Proportion of Treatment Failures Within 12 Months After Randomization to Study Drug. Lost to follow up	4 participants	5 participants

SECONDARY outcome

Timeframe: 734 days

Population: All 543 randomized patients were included in the analysis population.

Treatment failure is a composite endpoint; a patient is considered a treatment failure if the patient experienced any of the following events during this period (day 1 to day 734): death, graft failure, BPAR (Banff grade ≥1A) or lost to follow-up.

Outcome measures

Measure	LCP-Tacro n=268 Participants The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.	Prograf (Tacrolimus) n=275 Participants Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study. Prograf (tacrolimus): Administered per current product labeling
For the 24-month Analysis, the Endpoint Includes Additional Treatment Failures That Occurred During the 12-month Treatment Extension Period, up to Day 734 After the Randomization Date. Death	11 participants	13 participants
For the 24-month Analysis, the Endpoint Includes Additional Treatment Failures That Occurred During the 12-month Treatment Extension Period, up to Day 734 After the Randomization Date. Graft Failure	11 participants	15 participants
For the 24-month Analysis, the Endpoint Includes Additional Treatment Failures That Occurred During the 12-month Treatment Extension Period, up to Day 734 After the Randomization Date. Biobsy Proven Acute Rejection	46 participants	50 participants
For the 24-month Analysis, the Endpoint Includes Additional Treatment Failures That Occurred During the 12-month Treatment Extension Period, up to Day 734 After the Randomization Date. Lost to follow up	4 participants	8 participants

Adverse Events

LCP-Tacro

Serious events: 166 serious events

Other events: 263 other events

Deaths: 0 deaths

Prograf (Tacrolimus)

Serious events: 185 serious events

Other events: 269 other events

Deaths: 0 deaths

Serious adverse events

Measure	LCP-Tacro n=268 participants at risk The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.	Prograf (Tacrolimus) n=275 participants at risk Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study. Prograf (tacrolimus): Administered per current product labeling
Blood and lymphatic system disorders Anaemia	1.5% 4/268 • Number of events 4 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	2.2% 6/275 • Number of events 6 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Blood and lymphatic system disorders Agranulocytosis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Blood and lymphatic system disorders Leukopenia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Blood and lymphatic system disorders Neutropenia	1.1% 3/268 • Number of events 5 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Blood and lymphatic system disorders Thrombotic Microangiopathy	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Blood and lymphatic system disorders Haemolytic Anaemie	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Blood and lymphatic system disorders Haemolytic Uraemic Syndrome	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Blood and lymphatic system disorders Leukocytosis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Cardiac disorders Atrial Fibrilation	0.37% 1/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Cardiac disorders Cardiac Failure	0.75% 2/268 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 5 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Cardiac disorders Acute coronary syndrome	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Cardiac disorders Acute myocardial infarction	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Cardiac disorders Cardiac failure congestive	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Cardiac disorders Pericarditis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Cardiac disorders Angina Pectoris	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Cardiac disorders Cardiac arrest	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Cardiac disorders Cardiopulmonary failure	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Cardiac disorders Coronary artery disease	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Cardiac disorders Coronary artery stenosis	3.4% 9/268 • Number of events 9 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Cardiac disorders Tachyarrhytmia	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Congenital, familial and genetic disorders Aplasia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Congenital, familial and genetic disorders Congenital cystic kidney disease	0.37% 1/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Ear and labyrinth disorders Vertigo	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Endocrine disorders Hyperparathyroidism	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Endocrine disorders Goitre	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Diarrhoea	3.4% 9/268 • Number of events 9 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	2.5% 7/275 • Number of events 8 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Abdominal pain	1.1% 3/268 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Small intestinal obstruction	0.75% 2/268 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Colitis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Gastric ulcer	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Enterocolitis	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Gatritis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Gastrointestinal hypomotility	0.75% 2/268 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Inguinal Hernia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Intestinal obstruction	0.37% 1/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Retroperitoneal haematoma	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Vomitting	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Abdominal Hernia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Abdominal hernia obstructive	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Aphthous stomatitis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Duodenitis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Enterocutaneous Fistula	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Flatulence	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Gastric polyps	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Gastroinstestinal erosion	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Ileus	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Impaired gastric emptying	0.37% 1/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Intestinal Ischaemie	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Large intestine perforation	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Mouth ulceration	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Oesophagitis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Pancreatitis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Peptic ulcer	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Peritoneal haematoma	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Peritoneal haemorrhage	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Small intestine perforation	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
General disorders Pyrexia	1.5% 4/268 • Number of events 4 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
General disorders Asthenia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
General disorders Catheter site erosion	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
General disorders Death	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
General disorders Drug intolerance	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
General disorders Drug withdrawal syndrome	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
General disorders Multi-organ failure	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
General disorders Non-cardiac chest pain	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
General disorders Organ Failure	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Hepatobiliary disorders Cholesystitis acute	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Hepatobiliary disorders Cholelithiasis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Immune system disorders Kidney transplant rejection	8.6% 23/268 • Number of events 28 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	12.0% 33/275 • Number of events 39 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Immune system disorders Drug hypersensitivity	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Immune system disorders Pancreas transplant rejection	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Urinary tract infection	9.7% 26/268 • Number of events 34 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	8.0% 22/275 • Number of events 41 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Cytomegalovirus infection	4.5% 12/268 • Number of events 13 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	3.6% 10/275 • Number of events 12 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Pneumonia	1.5% 4/268 • Number of events 5 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	3.6% 10/275 • Number of events 10 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Gastroenteritis	3.4% 9/268 • Number of events 10 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Pyelonephritis	2.6% 7/268 • Number of events 8 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.8% 5/275 • Number of events 6 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Sepsis	1.9% 5/268 • Number of events 8 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	2.2% 6/275 • Number of events 10 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Urosepsis	2.2% 6/268 • Number of events 7 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.8% 5/275 • Number of events 6 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Bronchitis	1.1% 3/268 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Escherichia urinary tract infection	0.75% 2/268 • Number of events 4 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Cellulitis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.5% 4/275 • Number of events 4 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Upper respiratory tract infection	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Cytomegalovirus viraemia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Polyomavirus-associated nephropathy	1.1% 3/268 • Number of events 5 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Abscess limb	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations BK virus infection	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Bacterial sepsis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Bronchopneumonia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Escherichia sepsis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Gangrene	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Gastroenteritis norovirus	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Herpes Zoster	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Herpes Zoster disseminated	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Klebsiella	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Postoperative wound infection	0.75% 2/268 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Pyelonephritis acute	0.75% 2/268 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Respiratory tract infection	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Urinary tract infection bacterial	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Viral infection	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Adenoviral haemorrhagic cystitis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Adenovirus infection	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Arteriovenous fistula site infection	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Arthritis bacterial	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Arthritis infective	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Aspergillus infection	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Asymptomatic bacteriuria	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Bacteraemia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Bacterial pyelonephritis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Bronchitis viral	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Clostridium difficile colitits	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Clostridium difficile infection	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Coxsackie viral infection	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Cytomegalovirus gastroenteritis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Cytomegalovirus gastrointestinal infection	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Cytomegalovirus hepatitis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Device related infection	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Diabetic foot infection	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Enterobacter bacteraemia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Enterobacter infection	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Enterococcal infection	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Enterocolitits bacterial	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Escherichia bacteraemia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Escherichia infection	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Gastroenteritis viral	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Gastrointestinal infection	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Gingivitis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Herpes virus infection	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Human polyomavirus infection	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Influenza	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Klebsiella bacteraemia	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Klebsiella sepsis	0.37% 1/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Lower respiratory tract infection	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Lung infection	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Oesophageal candidiasis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Oral Candidiasis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Oral herpes	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Oral infection	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Osteomyelitis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Peritonitis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Pneumonia cytomegaloviral	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Pneumonia klebsiella	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Prostatitis escherichia coli	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Respiratory syncytial virus infection	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Sinusitis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Staphylococcal sepsis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Typhoid fever	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Urinary baldder abscess	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Urinary tract infection fungal	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Varicella	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Viraemia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Wound Abscess	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Complications of transplanted kidney	3.0% 8/268 • Number of events 8 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	6.5% 18/275 • Number of events 18 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Graft dysfunction	2.6% 7/268 • Number of events 12 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	2.5% 7/275 • Number of events 9 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Transplant failure	1.5% 4/268 • Number of events 6 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 5 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Toxicity to various agents	1.5% 4/268 • Number of events 4 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Graft Thrombosis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Graft Complications	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Shunt Thrombosis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Wound dehiscence	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Acetabulum fracture	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Ankle frature	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Arteriovenous fistula aneurysm	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Arteriovenous fistula site complications	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Cardiac valve replacement complications	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Limb injury	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Penetrating abdominal trauma	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Perirenal kaematoma	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Post precedural haematuria	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Post procedural urine leak	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Road traffic accident	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Traumatic fracture	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Upper limb fracture	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Vascular graft thrombosis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Wound complication	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Wound haemorrhage	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Wrist fracture	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Investigations Blood creatinine increased	3.0% 8/268 • Number of events 9 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	4.7% 13/275 • Number of events 17 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Investigations Liver function test abnormal	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Investigations Body temperature increased	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Investigations Immunosuppressant drug level increased	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Diabetes mellitus	3.7% 10/268 • Number of events 10 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	2.2% 6/275 • Number of events 6 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Dehydration	1.5% 4/268 • Number of events 5 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hyperglycemia	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hypercalcaemia	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hyponatraemia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Diabetes mellitus inadeqaute control	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Diabetes with hyperosmolarity	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Fluid overload	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hypomagnesaemia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Ketoacidosis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Musculoskeletal and connective tissue disorders Pain in extrenities	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Musculoskeletal and connective tissue disorders Back pain	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Musculoskeletal and connective tissue disorders Intervertebral disc protusion	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic cancer	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seminoma	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Convulsion	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Cerebrovascular accident	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Ischaemic stroke	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Sciatica	0.37% 1/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Carotid artery stenosis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Carpal tunnel syndrome	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Cerebral haemorrhage	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Complex regional pain syndrome	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Guillain-Barre syndrome	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Intracranial haematoma	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Neurotoxicity	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Status epilepticus	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Aubarachnoid haemorrhage	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Syncope	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Transient Ischaemic attack	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders VIIth nerve paralysis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Psychiatric disorders Mental status change	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Psychiatric disorders Anxiety	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Psychiatric disorders Panic attack	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Psychiatric disorders Panic disorder	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Psychiatric disorders Psychotic disorder	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Psychiatric disorders Suicidal ideation	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Psychiatric disorders Suicidal attempt	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Renal failure acute	2.2% 6/268 • Number of events 6 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	4.4% 12/275 • Number of events 19 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Renal impairment	1.5% 4/268 • Number of events 4 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	2.2% 6/275 • Number of events 7 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Renal artery stenosis	1.1% 3/268 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 4 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Ureteric artery stenosis	1.1% 3/268 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Haematuria	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Nephropathy toxic	1.5% 4/268 • Number of events 4 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Tubulointerstitial nephritis	1.1% 3/268 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Urinary fistula	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Urinary retention	1.1% 3/268 • Number of events 5 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Urinary tract obstruction	1.1% 3/268 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Hydronephrosis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Renal artery Thrombosis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Ureteral necrosis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Focal segmental glomerulosclerosis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Nephropathy	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Obstructive Uropathy	0.37% 1/268 • Number of events 4 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Renal cyst ruptures	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Renal vein thrombosis	0.37% 1/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Urinary bladder haemorrhage	0.37% 1/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Urinoma	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Acute prerenal failure	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Azotaemia	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Bladder obstruction	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Bladder outlet obstruction	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Bladder spasm	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Glomerulonephritis membranous	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Renal haemorrhage	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Renal necrosis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Renal pain	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Ureteral disorder	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Ureteric obstruction	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Urethral meatus stenosis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Urethral obstruction	0.37% 1/268 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Urethral stenosis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Reproductive system and breast disorders Benign prostatic hyperplasia	1.5% 4/268 • Number of events 4 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Reproductive system and breast disorders Prostatitis	0.37% 1/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Reproductive system and breast disorders Epididymitis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Reproductive system and breast disorders Ovarian cyst	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Reproductive system and breast disorders Uterine inflammation	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Reproductive system and breast disorders Uterine prolaps	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.5% 4/275 • Number of events 4 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.37% 1/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.37% 1/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Asthma	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.37% 1/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Skin and subcutaneous tissue disorders Diabetic foot	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Skin and subcutaneous tissue disorders Skin ulcer	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Skin and subcutaneous tissue disorders Skin necrosis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Social circumstances Pregnancy partner	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Surgical and medical procedures Lymphocele marsipialisation	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Lymphocele	1.1% 3/268 • Number of events 4 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	3.3% 9/275 • Number of events 15 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Hypertension	0.75% 2/268 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Deep vein thrombosis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	1.1% 3/275 • Number of events 3 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Peripheral ischaemia	1.1% 3/268 • Number of events 7 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Arterial thrombosis	0.75% 2/268 • Number of events 7 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Intra-abdominal haematoma	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Peripheral arterial occlusive disease	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Venous thrombosis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.73% 2/275 • Number of events 2 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Arteriovenous fistula	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Embolism arterial	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Extrinsic iliac vein compression	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Haematoma	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Hypotension	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Lymphorrhoea	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Phlebitis	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Shock haemorrhagic	0.00% 0/268 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.36% 1/275 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Thrombophlebitis	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Thrombophlebitis superficial	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Venoocclusive disease	0.37% 1/268 • Number of events 1 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	0.00% 0/275 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.

Other adverse events

Measure	LCP-Tacro n=268 participants at risk The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.	Prograf (Tacrolimus) n=275 participants at risk Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study. Prograf (tacrolimus): Administered per current product labeling
Blood and lymphatic system disorders Anaemia	28.0% 75/268 • Number of events 91 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	30.5% 84/275 • Number of events 98 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Blood and lymphatic system disorders Leukopenia	13.8% 37/268 • Number of events 43 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	14.2% 39/275 • Number of events 42 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Blood and lymphatic system disorders Polycythaemia	6.3% 17/268 • Number of events 22 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	6.9% 19/275 • Number of events 22 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Diarrhoea	34.0% 91/268 • Number of events 125 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	37.1% 102/275 • Number of events 159 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Constipation	19.0% 51/268 • Number of events 56 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	24.7% 68/275 • Number of events 81 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Nausea	14.9% 40/268 • Number of events 57 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	15.6% 43/275 • Number of events 52 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Abdominal pain	9.0% 24/268 • Number of events 28 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	12.0% 33/275 • Number of events 40 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Vomiting	6.3% 17/268 • Number of events 22 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	9.5% 26/275 • Number of events 30 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Dyspepsia	7.1% 19/268 • Number of events 20 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	6.9% 19/275 • Number of events 21 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Gastrointestinal disorders Abdominal pain upper	5.2% 14/268 • Number of events 18 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	5.1% 14/275 • Number of events 15 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
General disorders Oedema peripheral	18.7% 50/268 • Number of events 78 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	24.0% 66/275 • Number of events 90 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
General disorders Pyrexia	8.6% 23/268 • Number of events 27 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	7.6% 21/275 • Number of events 25 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
General disorders Asthenia	5.2% 14/268 • Number of events 15 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	4.7% 13/275 • Number of events 15 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Immune system disorders Kidney transplant rejection	14.2% 38/268 • Number of events 49 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	16.4% 45/275 • Number of events 55 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Urinary tract infection	30.2% 81/268 • Number of events 136 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	29.1% 80/275 • Number of events 169 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations BK virus infection	8.6% 23/268 • Number of events 28 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	10.5% 29/275 • Number of events 34 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Upper respiratory tract infection	11.2% 30/268 • Number of events 39 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	7.6% 21/275 • Number of events 26 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Nasopharyngitis	9.7% 26/268 • Number of events 30 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	6.5% 18/275 • Number of events 21 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Cytomegalovirus infection	7.8% 21/268 • Number of events 26 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	6.5% 18/275 • Number of events 27 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Gastroenteritis	7.8% 21/268 • Number of events 25 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	4.7% 13/275 • Number of events 14 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Sinusitis	4.9% 13/268 • Number of events 17 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	6.9% 19/275 • Number of events 25 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Infections and infestations Bronchitits	6.7% 18/268 • Number of events 18 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	4.4% 12/275 • Number of events 16 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Complications of kidney transplant	7.5% 20/268 • Number of events 23 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	10.9% 30/275 • Number of events 33 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Wound complication	7.5% 20/268 • Number of events 24 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	6.5% 18/275 • Number of events 21 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Injury, poisoning and procedural complications Procedural pain	5.2% 14/268 • Number of events 15 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	6.9% 19/275 • Number of events 21 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Investigations Blood creatinine increased	12.3% 33/268 • Number of events 44 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	14.2% 39/275 • Number of events 53 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Investigations Weight increased	7.8% 21/268 • Number of events 25 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	8.0% 22/275 • Number of events 23 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Diabetes mellitus	20.5% 55/268 • Number of events 64 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	15.3% 42/275 • Number of events 49 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hypophosphataemia	13.4% 36/268 • Number of events 45 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	15.3% 42/275 • Number of events 46 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hyperkalaemia	15.7% 42/268 • Number of events 52 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	12.4% 34/275 • Number of events 40 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hypokalaemia	12.7% 34/268 • Number of events 38 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	13.5% 37/275 • Number of events 46 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hyperglycemia	11.6% 31/268 • Number of events 34 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	13.5% 37/275 • Number of events 42 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hypomagnesaemia	12.7% 34/268 • Number of events 41 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	12.0% 33/275 • Number of events 39 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Vitamin D deficiency	10.1% 27/268 • Number of events 28 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	9.8% 27/275 • Number of events 29 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hypucalcaemia	7.8% 21/268 • Number of events 23 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	9.1% 25/275 • Number of events 25 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Dyslipidaemia	8.6% 23/268 • Number of events 24 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	6.2% 17/275 • Number of events 19 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Metabolic acidosis	8.2% 22/268 • Number of events 24 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	5.8% 16/275 • Number of events 18 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hypercholesterolaemia	6.0% 16/268 • Number of events 17 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	5.8% 16/275 • Number of events 16 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hyperuricaemia	3.7% 10/268 • Number of events 10 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	7.3% 20/275 • Number of events 21 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Musculoskeletal and connective tissue disorders Muscle spasms	5.2% 14/268 • Number of events 17 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	5.8% 16/275 • Number of events 16 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hyperlipidaemia	5.2% 14/268 • Number of events 14 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	5.5% 15/275 • Number of events 15 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Hypertriglyceridaemia	5.2% 14/268 • Number of events 15 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	5.5% 15/275 • Number of events 16 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Metabolism and nutrition disorders Dehydration	5.2% 14/268 • Number of events 17 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	2.9% 8/275 • Number of events 8 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Musculoskeletal and connective tissue disorders Back pain	8.2% 22/268 • Number of events 24 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	6.5% 18/275 • Number of events 22 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Musculoskeletal and connective tissue disorders Pain in extrimity	8.2% 22/268 • Number of events 25 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	6.2% 17/275 • Number of events 22 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Musculoskeletal and connective tissue disorders Arthralgia	6.3% 17/268 • Number of events 17 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	5.1% 14/275 • Number of events 17 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Tremor	22.0% 59/268 • Number of events 66 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	18.5% 51/275 • Number of events 60 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Headache	16.0% 43/268 • Number of events 54 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	10.5% 29/275 • Number of events 41 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Dizziness	7.1% 19/268 • Number of events 21 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	5.1% 14/275 • Number of events 18 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Psychiatric disorders Insomnia	14.2% 38/268 • Number of events 42 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	10.5% 29/275 • Number of events 32 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Nervous system disorders Anxiety	9.0% 24/268 • Number of events 28 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	9.1% 25/275 • Number of events 30 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Renal impairment	7.5% 20/268 • Number of events 23 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	9.8% 27/275 • Number of events 37 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Proteinuria	7.1% 19/268 • Number of events 20 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	7.6% 21/275 • Number of events 24 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Haematuria	6.7% 18/268 • Number of events 20 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	7.3% 20/275 • Number of events 23 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Dysuria	7.5% 20/268 • Number of events 26 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	5.5% 15/275 • Number of events 15 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Renal and urinary disorders Renal failure acute	4.5% 12/268 • Number of events 13 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	6.2% 17/275 • Number of events 28 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Cough	9.0% 24/268 • Number of events 29 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	10.9% 30/275 • Number of events 32 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.4% 9/268 • Number of events 9 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	7.6% 21/275 • Number of events 24 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Skin and subcutaneous tissue disorders Alopecia	6.0% 16/268 • Number of events 19 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	7.6% 21/275 • Number of events 23 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Skin and subcutaneous tissue disorders Acne	6.3% 17/268 • Number of events 18 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	6.9% 19/275 • Number of events 20 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Hypertension	26.5% 71/268 • Number of events 81 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	26.5% 73/275 • Number of events 88 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Hypotension	7.5% 20/268 • Number of events 21 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	5.5% 15/275 • Number of events 18 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.
Vascular disorders Lymphocele	1.9% 5/268 • Number of events 6 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.	5.5% 15/275 • Number of events 22 • Adverse events were collected from day of first dose of study drug and up until 30 days after completing the 24 months study period.

Additional Information

Christina Sylvest

Veloxis Pharmaceuticals

Phone: +4520553877

Email: csy@veloxis.com

Results disclosure agreements

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

Restriction type: OTHER