Trial Outcomes & Findings for Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes (NCT NCT02513303)

NCT ID: NCT02513303

Last Updated: 2025-10-09

Results Overview

For subjects who are on hemodialysis by day 150, suitability for dialysis will be determined by the ability to use the fistula for dialysis using 2-needles with a mean dialysis machine blood pump speed of ≥300 mL/min for two-thirds of the dialysis sessions during a 30 day suitability ascertainment period that begins 150 days after fistula creation. For subjects who are not on hemodialysis on day of enrollment and who do not initiate hemodialysis by day 150, suitability for dialysis will be determined by a vascular ultrasound performed at the 6 month follow up visit. Suitability for dialysis will be defined as a fistula with an access vein diameter (AVD) of ≥6 mm (internal diameter) and an access blood flow of ≥500 mL/min.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 269 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-10-09

Participant Flow

Participant milestones

Measure	Sirogen Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery	Control Participants underwent AV fistula surgery without an implant	Run-in Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery. The first subject enrolled by a participating surgeon was a run-in subject; run-in subjects were part of the randomized set; all run-in subjects receive Sirogen.
Overall Study STARTED	125	118	26
Overall Study COMPLETED	105	101	22
Overall Study NOT COMPLETED	20	17	4

Reasons for withdrawal

Measure	Sirogen Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery	Control Participants underwent AV fistula surgery without an implant	Run-in Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery. The first subject enrolled by a participating surgeon was a run-in subject; run-in subjects were part of the randomized set; all run-in subjects receive Sirogen.
Overall Study Withdrawal by Subject	9	7	2
Overall Study Lost to Follow-up	2	4	0
Overall Study Adverse Event	0	1	0
Overall Study Physician Decision	1	1	0
Overall Study Death	8	4	2

Baseline Characteristics

Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes

Baseline characteristics by cohort

Measure	Sirogen n=125 Participants Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery	Control n=118 Participants Participants underwent AV fistula surgery without an implant	Run-in n=26 Participants Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery. The first subject enrolled by a participating surgeon was a run-in subject; run-in subjects were part of the randomized set; all run-in subjects receive Sirogen.	Total n=269 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	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	74 Participants n=93 Participants	82 Participants n=4 Participants	13 Participants n=27 Participants	169 Participants n=483 Participants
Age, Categorical >=65 years	51 Participants n=93 Participants	36 Participants n=4 Participants	13 Participants n=27 Participants	100 Participants n=483 Participants
Age, Continuous	59.7 years STANDARD_DEVIATION 14.9 • n=93 Participants	57.7 years STANDARD_DEVIATION 13.9 • n=4 Participants	61.4 years STANDARD_DEVIATION 17.3 • n=27 Participants	59.0 years STANDARD_DEVIATION 14.7 • n=483 Participants
Sex: Female, Male Female	28 Participants n=93 Participants	23 Participants n=4 Participants	6 Participants n=27 Participants	57 Participants n=483 Participants
Sex: Female, Male Male	97 Participants n=93 Participants	95 Participants n=4 Participants	20 Participants n=27 Participants	212 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Asian	8 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	12 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Black or African American	31 Participants n=93 Participants	30 Participants n=4 Participants	8 Participants n=27 Participants	69 Participants n=483 Participants
Race (NIH/OMB) White	84 Participants n=93 Participants	81 Participants n=4 Participants	15 Participants n=27 Participants	180 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	4 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants
Region of Enrollment United States	125 participants n=93 Participants	118 participants n=4 Participants	26 participants n=27 Participants	269 participants n=483 Participants
Kidney Disease Status at Enrollment Chronic kidney disease	33 Participants n=93 Participants	36 Participants n=4 Participants	1 Participants n=27 Participants	70 Participants n=483 Participants
Kidney Disease Status at Enrollment End stage renal disease	92 Participants n=93 Participants	82 Participants n=4 Participants	25 Participants n=27 Participants	199 Participants n=483 Participants

PRIMARY outcome

Timeframe: 6 months

For subjects who are on hemodialysis by day 150, suitability for dialysis will be determined by the ability to use the fistula for dialysis using 2-needles with a mean dialysis machine blood pump speed of ≥300 mL/min for two-thirds of the dialysis sessions during a 30 day suitability ascertainment period that begins 150 days after fistula creation.

For subjects who are not on hemodialysis on day of enrollment and who do not initiate hemodialysis by day 150, suitability for dialysis will be determined by a vascular ultrasound performed at the 6 month follow up visit. Suitability for dialysis will be defined as a fistula with an access vein diameter (AVD) of ≥6 mm (internal diameter) and an access blood flow of ≥500 mL/min.

Outcome measures

Measure	Sirogen n=125 Participants Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery	Control n=118 Participants Participants underwent AV fistula surgery without an implant	Run-in n=26 Participants Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery. The first subject enrolled by a participating surgeon was a run-in subject; run-in subjects were part of the randomized set; all run-in subjects receive Sirogen.
Fistula Suitability for Dialysis at 6 Months (FSD6) Met FSD6 criteria	74 Participants	76 Participants	21 Participants
Fistula Suitability for Dialysis at 6 Months (FSD6) Did not meet FSD6 criteria	43 Participants	35 Participants	5 Participants
Fistula Suitability for Dialysis at 6 Months (FSD6) Indeterminant FSD6	8 Participants	7 Participants	0 Participants

Adverse Events

Sirogen

Serious events: 56 serious events

Other events: 115 other events

Deaths: 8 deaths

Control

Serious events: 55 serious events

Other events: 101 other events

Deaths: 4 deaths

Run-in

Serious events: 15 serious events

Other events: 24 other events

Deaths: 2 deaths

Serious adverse events

Measure	Sirogen n=127 participants at risk Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery	Control n=116 participants at risk Participants underwent AV fistula surgery without an implant	Run-in n=26 participants at risk Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery. The first subject enrolled by a participating surgeon was a run-in subject; run-in subjects were part of the randomized set; all run-in subjects receive Sirogen.
Blood and lymphatic system disorders Anaemia	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	1.7% 2/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Acute coronary syndrome	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Acute myocardial infarction	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Angina pectoris	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Angina unstable	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Atrial fibrillation	3.1% 4/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Atrial flutter	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Atrioventricular block complete	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	1.7% 2/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Bradycardia	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Cardiac arrest	2.4% 3/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	7.7% 2/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Cardiac failure acute	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	4.3% 5/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Cardiac failure chronic	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Cardiac failure congestive	5.5% 7/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	2.6% 3/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Cardiogenic shock	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Cardiomyopathy	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Coronary artery disease	2.4% 3/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Coronary ostial stenosis	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Myocardial infarction	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Myocardial ischaemia	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Nodal rhythm	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Sinus bradycardia	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Sinus node dysfunction	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Cardiac disorders Ventricular arrhythmia	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Endocrine disorders Hyperparathyroidism	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Abdominal pain	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Colitis ischaemic	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Gastric haemorrhage	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	1.7% 2/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Nausea	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Small intestinal obstruction	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Vomiting	2.4% 3/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
General disorders Asthenia	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	1.7% 2/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
General disorders Chest pain	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
General disorders Multiple organ dysfunction syndrome	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
General disorders Non-cardiac chest pain	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Hepatobiliary disorders Biliary tract disorder	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Hepatobiliary disorders Cholecystitis acute	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Hepatobiliary disorders Cholelithiasis	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Appendicitis	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Bronchitis	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Cellulitis	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	1.7% 2/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Clostridium difficile colitis	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Clostridium difficile infection	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Corona virus infection	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Cystitis bacterial	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Device related infection	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Device related sepsis	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Enterobacter bacteraemia	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Escherichia urinary tract infection	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Gangrene	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Influenza	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Klebsiella bacteraemia	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Osteomyelitis	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Peritonitis bacterial	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Pleural infection bacterial	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Pneumonia	4.7% 6/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	5.2% 6/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Postoperative wound infection	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Pseudomonal bacteraemia	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Respiratory tract infection viral	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Rhinovirus infection	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Sepsis	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	11.5% 3/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Septic shock	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Staphylococcal bacteraemia	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Staphylococcal sepsis	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Streptococcal bacteraemia	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Subcutaneous abscess	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Infections and infestations Urinary tract infection	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Arteriovenous fistula maturation failure	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	3.1% 4/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	2.6% 3/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Fall	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Femur fracture	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Hip fracture	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Injury	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Vascular access malfunction	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Investigations Blood glucose decreased	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Investigations Ejection fraction decreased	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Investigations Troponin increased	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Metabolism and nutrition disorders Fluid overload	2.4% 3/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	4.3% 5/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	7.7% 2/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Metabolism and nutrition disorders Hypercalcaemia	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Metabolism and nutrition disorders Hyperglycaemia	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Metabolism and nutrition disorders Hyperkalaemia	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	5.2% 6/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	7.7% 2/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Metabolism and nutrition disorders Hypoglycaemia	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	1.7% 2/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Musculoskeletal and connective tissue disorders Joint effusion	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Nervous system disorders Brain injury	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Nervous system disorders Carotid artery stenosis	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Nervous system disorders Cerebrovascular accident	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Nervous system disorders Encephalopathy	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Nervous system disorders Hydrocephalus	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Nervous system disorders Intraventricular haemorrhage	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Nervous system disorders Metabolic encephalopathy	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	1.7% 2/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Nervous system disorders Presyncope	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Nervous system disorders Syncope	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	11.5% 3/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Nervous system disorders Uraemic encephalopathy	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Psychiatric disorders Suicidal ideation	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Renal and urinary disorders Acute kidney injury	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Renal and urinary disorders Azotaemia	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	2.6% 3/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Renal and urinary disorders Chronic kidney disease	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Renal and urinary disorders End stage renal disease	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	4.3% 5/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	11.5% 3/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Renal and urinary disorders Urinary retention	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	1.7% 2/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	7.7% 2/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.4% 3/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	1.7% 2/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	11.5% 3/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	4.3% 5/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Social circumstances Refusal of treatment by patient	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Surgical and medical procedures Atrial septal defect repair	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Surgical and medical procedures Renal transplant	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	1.7% 2/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Vascular disorders Accelerated hypertension	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Vascular disorders Deep vein thrombosis	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Vascular disorders Extremity necrosis	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Vascular disorders Hypertension	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Vascular disorders Hypertensive crisis	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.4% 4/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Vascular disorders Hypertensive emergency	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Vascular disorders Hypotension	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Vascular disorders Hypovolaemic shock	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Vascular disorders Peripheral ischaemia	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Vascular disorders Steal syndrome	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.

Other adverse events

Measure	Sirogen n=127 participants at risk Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery	Control n=116 participants at risk Participants underwent AV fistula surgery without an implant	Run-in n=26 participants at risk Participants received single administration of Sirolimus-eluting Collagen Implant (Sirogen) at the time of AV fistula surgery. The first subject enrolled by a participating surgeon was a run-in subject; run-in subjects were part of the randomized set; all run-in subjects receive Sirogen.
Eye disorders Vision blurred	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	7.7% 2/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Abdominal pain	2.4% 3/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	7.7% 2/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Constipation	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	11.5% 3/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Diarrhoea	5.5% 7/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	4.3% 5/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Gastrointestinal disorders Nausea	7.1% 9/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.4% 4/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Arteriovenous fistula occlusion	2.4% 3/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	6.0% 7/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	15.4% 4/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	55.9% 71/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	50.9% 59/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	53.8% 14/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	13.4% 17/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	15.5% 18/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	23.1% 6/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Haemodialysis complication	32.3% 41/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	30.2% 35/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	23.1% 6/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Haemodialysis-induced symptom	8.7% 11/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	5.2% 6/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	3.8% 1/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Injury, poisoning and procedural complications Wound dehiscence	6.3% 8/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Metabolism and nutrition disorders Fluid overload	0.79% 1/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	7.7% 2/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Metabolism and nutrition disorders Hyperkalaemia	2.4% 3/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	5.2% 6/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.00% 0/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Musculoskeletal and connective tissue disorders Muscle spasms	1.6% 2/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	1.7% 2/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	11.5% 3/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Nervous system disorders Dizziness	5.5% 7/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	1.7% 2/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	7.7% 2/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Psychiatric disorders Insomnia	0.00% 0/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	0.86% 1/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	7.7% 2/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.
Vascular disorders Hypotension	2.4% 3/127 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	2.6% 3/116 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.	7.7% 2/26 • 1 year The safety set for adverse event reporting comprises of patients assigned to control arm having received investigational product.

Additional Information

Rakesh Raghubanshi

Vascular Therapies, Inc.

Phone: 9176204369

Email: rakesh@vasculartx.com

Results disclosure agreements

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