Trial Outcomes & Findings for The Effect Of Acadesine On Reducing Cardiovascular and Cerebrovascular Adverse Events In Coronary Artery Bypass Graft (CABG) Surgery (Study P05633 AM1)(TERMINATED) (NCT NCT00872001)

NCT ID: NCT00872001

Last Updated: 2015-10-29

Results Overview

Incidence of all-cause death, non-fatal stroke, or need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: All-cause death: Death from any cause, Non-fatal Stoke: occurrence of a stoke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 3080 participants
• Primary outcome timeframe: Up to Post-Operative Day 28
• Results posted on: 2015-10-29

Participant Flow

Participant milestones

Measure	Acadesine Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)	Placebo (Normal Saline) Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
Overall Study STARTED	1536	1544
Overall Study COMPLETED	1400	1413
Overall Study NOT COMPLETED	136	131

Reasons for withdrawal

Measure	Acadesine Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)	Placebo (Normal Saline) Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
Overall Study Adverse Event	34	23
Overall Study Protocol Defined Clinical Event	5	7
Overall Study Lost to Follow-up	13	12
Overall Study Withdrawal by Subject	18	30
Overall Study Protocol Violation	5	8
Overall Study Did Not Meet Protocol Eligibility	38	36
Overall Study Administrative	23	15

Baseline Characteristics

The Effect Of Acadesine On Reducing Cardiovascular and Cerebrovascular Adverse Events In Coronary Artery Bypass Graft (CABG) Surgery (Study P05633 AM1)(TERMINATED)

Baseline characteristics by cohort

Measure	Acadesine n=1536 Participants Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)	Placebo (Normal Saline) n=1544 Participants Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB	Total n=3080 Participants Total of all reporting groups
Age, Continuous	66.2 years STANDARD_DEVIATION 8.5 • n=5 Participants	66.7 years STANDARD_DEVIATION 8.7 • n=7 Participants	66.5 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	519 Participants n=5 Participants	523 Participants n=7 Participants	1042 Participants n=5 Participants
Sex: Female, Male Male	1017 Participants n=5 Participants	1021 Participants n=7 Participants	2038 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Post-Operative Day 28

Population: The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite.

Incidence of all-cause death, non-fatal stroke, or need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: All-cause death: Death from any cause, Non-fatal Stoke: occurrence of a stoke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.

Outcome measures

Measure	Acadesine n=1536 Participants Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB).	Placebo n=1544 Participants Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB.
Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) Composite of All Events	4.9 Percentage of Participants	4.9 Percentage of Participants
Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) All-Cause Death	1.9 Percentage of Participants	1.7 Percentage of Participants
Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) Non-Fatal Stroke	1.7 Percentage of Participants	1.7 Percentage of Participants
Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) Need for Mechanical Support for SLVD	2.2 Percentage of Participants	2.3 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Post-Operative Day 28

Population: The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite.

Incidence of cardiovascular death, non-fatal stroke, and need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: Cardiovascular death: Death due to cardiovascular causes, Non-fatal Stroke: occurrence of a stroke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output.

Outcome measures

Measure	Acadesine n=1536 Participants Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB).	Placebo n=1544 Participants Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB.
Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population) Composite of All Events	4.8 Percentage of Participants	4.7 Percentage of Participants
Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population) Cardiovascular Death	1.7 Percentage of Participants	1.6 Percentage of Participants
Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population) Non-Fatal Stroke	1.7 Percentage of Participants	1.7 Percentage of Participants
Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population) Need for Mechanical Support for SLVD	2.2 Percentage of Participants	2.3 Percentage of Participants

Adverse Events

Acadesine

Serious events: 327 serious events

Other events: 1154 other events

Deaths: 0 deaths

Placebo (Normal Saline)

Serious events: 329 serious events

Other events: 1189 other events

Deaths: 0 deaths

Serious adverse events

Measure	Acadesine n=1442 participants at risk Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)	Placebo (Normal Saline) n=1457 participants at risk Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
Vascular disorders Arterial Thrombosis Limb	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Arteriovenous Fistula	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Deep Vein Thrombosis	0.62% 9/1442 • Number of events 9 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.34% 5/1457 • Number of events 5 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Blood and lymphatic system disorders Anaemia	0.42% 6/1442 • Number of events 6 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Blood and lymphatic system disorders Coagulopathy	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Blood and lymphatic system disorders Heparin-Induced Thrombocytopenia	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Blood and lymphatic system disorders Leukocytosis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Blood and lymphatic system disorders Thrombocytopenia	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Acute Myocardial Infarction	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Atrial Fibrillation	3.1% 44/1442 • Number of events 46 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	2.8% 41/1457 • Number of events 41 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Atrial Flutter	0.14% 2/1442 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.41% 6/1457 • Number of events 6 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Atrial Rupture	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Atrioventricular Block Complete	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Bradycardia	0.28% 4/1442 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.27% 4/1457 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Cardiac Arrest	0.83% 12/1442 • Number of events 14 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.48% 7/1457 • Number of events 8 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Cardiac Failure	0.35% 5/1442 • Number of events 5 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Cardiac Failure Congestive	0.76% 11/1442 • Number of events 11 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.82% 12/1457 • Number of events 13 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Cardiac Tamponade	0.28% 4/1442 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.27% 4/1457 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Cardiac Valve Disease	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Cardio-Respiratory Arrest	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.27% 4/1457 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Cardiogenic Shock	0.28% 4/1442 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.21% 3/1457 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Cardiopulmonary Failure	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Electromechanical Dissociation	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Nodal Rhythm	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Pericardial Effusion	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.27% 4/1457 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Right Ventricular Failure	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Sick Sinus Syndrome	0.28% 4/1442 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.27% 4/1457 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Sinus Bradycardia	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Supraventricular Extrasystoles	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Tachyarrhythmia	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Tachycardia	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Ventricle Rupture	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Ventricular Arrhythmia	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Ventricular Extrasystoles	0.21% 3/1442 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.27% 4/1457 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Ventricular Fibrillation	0.35% 5/1442 • Number of events 5 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.41% 6/1457 • Number of events 6 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Ventricular Tachycardia	0.21% 3/1442 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.21% 3/1457 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Endocrine disorders Inappropriate Antidiuretic Hormone Secretion	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Eye disorders Diabetic Retinopathy	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Abdominal Adhesions	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Abdominal Distension	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Abdominal Pain	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Abdominal Pain Upper	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Ascites	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Colitis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Colitis Ulcerative	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Diarrhoea	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Duodenal Ulcer Haemorrhage	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Dyspepsia	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Dysphagia	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Faecaloma	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Gastric Ulcer	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Gastritis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Gastrointestional Necrosis	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.28% 4/1442 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.34% 5/1457 • Number of events 5 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Haematemesis	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Ileus	0.35% 5/1442 • Number of events 5 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.27% 4/1457 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Ileus Paralytic	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Impaired Gastric Emptying	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Intestinal Ischaemia	0.28% 4/1442 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.21% 3/1457 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Intestinal Obstruction	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Large Intestine Perforation	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Mallory-Weiss Syndrome	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Malaena	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Nausea	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Oesophageal Spasm	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Oesophageal Varices Haemorrhage	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Peritonitis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Small Intestinal Obstruction	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Adverse Drug Reaction	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Asthenia	0.28% 4/1442 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Catheter Site Haemorrhage	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Chest Pain	0.42% 6/1442 • Number of events 6 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Device Occlusion	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Extravasation	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Fatigue	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Gait Disturbance	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders General Physical Health Deterioration	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Impaired Healing	0.21% 3/1442 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Multi-Organ Failure	0.28% 4/1442 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Non-Cardiac Chest Pain	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Oedema	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Oedema Peripheral	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Organ Failure	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Sudden Cardiac Death	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Systemic Inflammatory Response Syndrome	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Hepatobiliary disorders Cholecystitis	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Hepatobiliary disorders Cholecystitis Acute	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Hepatobiliary disorders Cholelithiasis	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Hepatobiliary disorders Hepatic Failure	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Hepatobiliary disorders Hydrocholecystis	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Immune system disorders Anaphylactic Reaction	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Immune system disorders Anaphylactoid Reaction	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Abscess Limb	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Bacterial Sepsis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Bronchitis	0.21% 3/1442 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Bronchopneumonia	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Cellulitus	0.35% 5/1442 • Number of events 5 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.55% 8/1457 • Number of events 8 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Cholecystitis Infective	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Clostridial Infection	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Drug Related Sepsis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Escherichia Bacteraemia	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Gangrene	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Gastroenteritis	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Gastroenteritis Viral	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Haematoma Infection	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Incision Site Infection	0.21% 3/1442 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.21% 3/1457 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Infection	0.62% 9/1442 • Number of events 9 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.62% 9/1457 • Number of events 10 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Mediastinal Abscess	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Mediastinitis	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Pharyngitis Streptococcal	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Pneumonia	0.69% 10/1442 • Number of events 10 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.96% 14/1457 • Number of events 14 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Postoperative Wound Infection	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Pyelonepritis	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Pyothorax	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Respiratory Tract Infection	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Sepsis	0.49% 7/1442 • Number of events 7 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.41% 6/1457 • Number of events 6 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Septic Shock	0.28% 4/1442 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Staphylococcal Infection	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Staphylococcal Mediastinitis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Urinary Tract Infection	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.27% 4/1457 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Wound Infection	0.42% 6/1442 • Number of events 6 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.41% 6/1457 • Number of events 6 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Wound Infection Pseudomonas	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Infections and infestations Wound Infection Staphylococcal	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Collapse of Lung	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Drug Toxicity	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Femur Fracture	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Graft Haemorrhage	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Incision Site Haemorrhage	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Operative Haemorrhage	0.21% 3/1442 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Post Procedural Haemorrhage	1.1% 16/1442 • Number of events 16 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	1.2% 17/1457 • Number of events 17 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Postoperative Ileus	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Postoperative Renal Failure	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Postoperative Respiratory Distress	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.21% 3/1457 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Postoperative Thoracic Procedure Complication	0.55% 8/1442 • Number of events 8 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.21% 3/1457 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Postpericardiotomy Syndrome	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.27% 4/1457 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Renal Injury	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Shunt Thrombosis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Traumatic Lung Injury	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Vascular Graft Occlusion	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Vascular Graft Complication	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Vasoplegia Syndrome	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Weaning Failure	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Wound Complication	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Wound Dehiscence	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Investigations Cardiac Output Decreased	0.21% 3/1442 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Investigations Electrocardiogram Change	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Investigations International Normalised Ratio Increased	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Investigations Pulse Absent	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Investigations White Blood Cell Count Increased	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Metabolism and nutrition disorders Dehydration	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Metabolism and nutrition disorders Diabetes Mellitus	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Metabolism and nutrition disorders Electrolyte Imbalance	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Metabolism and nutrition disorders Fluid Overload	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Metabolism and nutrition disorders Hyperglycaemia	0.14% 2/1442 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Metabolism and nutrition disorders Hypoglycaemia	0.42% 6/1442 • Number of events 6 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Metabolism and nutrition disorders Metabolic Acidosis	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Metabolism and nutrition disorders Metabolic Disorder	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Musculoskeletal and connective tissue disorders Costochondritis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Musculoskeletal and connective tissue disorders Fracture Delayed Union	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Musculoskeletal and connective tissue disorders Pain in Extremity	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Nervous system disorders Anoxic Encephalopathy	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Nervous system disorders Carpal Tunnel Syndrome	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Nervous system disorders Cerebrovascular Incident	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Nervous system disorders Convulsion	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Nervous system disorders Depressed Level of Consciousness	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Nervous system disorders Encephalopathy	0.21% 3/1442 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Nervous system disorders Hypoxic Encephalopathy	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Nervous system disorders Metabolic Encephalopathy	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Nervous system disorders Paresis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Nervous system disorders Presynope	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Nervous system disorders Syncope	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Psychiatric disorders Affective Disorder	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Psychiatric disorders Depression	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Psychiatric disorders Disorientation	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Psychiatric disorders Hallucination, Visual	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Psychiatric disorders Mental Status Changes	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Psychiatric disorders Suicidal Ideation	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Psychiatric disorders Transient Psychosis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Renal and urinary disorders Acute Prerenal Failure	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Renal and urinary disorders Haematuria	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Renal and urinary disorders Renal Failure	1.4% 20/1442 • Number of events 21 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.96% 14/1457 • Number of events 14 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Renal and urinary disorders Renal Failure Acute	0.62% 9/1442 • Number of events 10 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.69% 10/1457 • Number of events 10 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Renal and urinary disorders Renal Tubular Necrosis	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Renal and urinary disorders Urinary Retention	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.42% 6/1442 • Number of events 7 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.21% 3/1457 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Acute Repiratory Failure	0.28% 4/1442 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.55% 8/1457 • Number of events 8 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Asphyxia	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary disease	0.28% 4/1442 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.21% 3/1442 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.27% 4/1457 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Lung Disorder	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Pleural Effusion	1.9% 28/1442 • Number of events 31 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	1.8% 26/1457 • Number of events 27 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Pleural Fistula	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.62% 9/1442 • Number of events 9 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.27% 4/1457 • Number of events 4 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.97% 14/1442 • Number of events 14 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.82% 12/1457 • Number of events 12 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Pulmonary Haematoma	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Pulmonary Haemorrhage	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Respiratory Alkalosis	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Respiratory Arrest	0.35% 5/1442 • Number of events 5 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.21% 3/1457 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.35% 5/1442 • Number of events 5 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.21% 3/1457 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Respiratory Failure	2.3% 33/1442 • Number of events 34 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	1.6% 23/1457 • Number of events 25 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Tracheal Stenosis	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Skin and subcutaneous tissue disorders Diabetic Ulcer	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Skin and subcutaneous tissue disorders Linear IGA Disease	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Skin and subcutaneous tissue disorders Subcutaneous Emphysema	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Surgical and medical procedures Aortic Bypass	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Surgical and medical procedures Incisional Drainage	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Surgical and medical procedures Mechanical Ventilation	0.21% 3/1442 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Surgical and medical procedures Thoracic Cavity Drainage	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.21% 3/1457 • Number of events 3 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Air Embolism	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Aortic Rupture	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Embolism	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Exsanguination	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Haematoma	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Haemodynamic Instability	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Haemorrhage	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Hypertension	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Hypertensive Crisis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Hypotension	0.97% 14/1442 • Number of events 16 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	1.2% 18/1457 • Number of events 18 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Jugular Vein Thrombosis	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Labile Blood Pressure	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Lymphatic Fistula	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Orthostatic Hypotension	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Peripheral Arterial Occlusive Disease	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Peripheral Embolism	0.07% 1/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Peripheral Ischaemia	0.14% 2/1442 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.14% 2/1457 • Number of events 2 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Peripheral Vascular Disorder	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Shock	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Shock Haemorrhagic	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.00% 0/1457 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Thrombophlebitis Superficial	0.07% 1/1442 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Venous Thrombosis	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders White Clot Syndrome	0.00% 0/1442 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	0.07% 1/1457 • Number of events 1 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).

Other adverse events

Measure	Acadesine n=1442 participants at risk Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)	Placebo (Normal Saline) n=1457 participants at risk Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
Blood and lymphatic system disorders Anaemia	26.6% 384/1442 • Number of events 388 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	26.3% 383/1457 • Number of events 387 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Blood and lymphatic system disorders Leukocytosis	7.9% 114/1442 • Number of events 117 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	6.5% 95/1457 • Number of events 95 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Blood and lymphatic system disorders Thrombocytopenia	8.3% 119/1442 • Number of events 123 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	8.9% 129/1457 • Number of events 129 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Atrial Fibrillation	20.1% 290/1442 • Number of events 303 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	22.5% 328/1457 • Number of events 346 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Cardiac disorders Sinus Tachycardia	5.6% 81/1442 • Number of events 82 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	4.6% 67/1457 • Number of events 67 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Constipation	14.4% 207/1442 • Number of events 209 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	16.7% 244/1457 • Number of events 245 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Nausea	24.5% 354/1442 • Number of events 362 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	25.1% 365/1457 • Number of events 373 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Gastrointestinal disorders Vomiting	5.5% 80/1442 • Number of events 81 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	5.9% 86/1457 • Number of events 86 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Generalized Oedema	6.0% 87/1442 • Number of events 87 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	5.8% 85/1457 • Number of events 85 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Oedema Peripheral	7.5% 108/1442 • Number of events 112 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	8.5% 124/1457 • Number of events 134 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Pain	6.9% 100/1442 • Number of events 100 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	8.2% 119/1457 • Number of events 123 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
General disorders Pyrexia	8.1% 117/1442 • Number of events 122 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	7.2% 105/1457 • Number of events 105 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Incision Site Pain	15.1% 218/1442 • Number of events 221 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	14.1% 205/1457 • Number of events 211 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Injury, poisoning and procedural complications Procedural Pain	38.8% 560/1442 • Number of events 572 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	36.0% 525/1457 • Number of events 543 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Metabolism and nutrition disorders Hyperglycaemia	12.5% 180/1442 • Number of events 181 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	11.3% 165/1457 • Number of events 165 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Metabolism and nutrition disorders Hypocalcaemia	5.9% 85/1442 • Number of events 86 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	5.1% 74/1457 • Number of events 74 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Metabolism and nutrition disorders Hypokalaemia	9.6% 139/1442 • Number of events 143 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	8.6% 126/1457 • Number of events 127 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Psychiatric disorders Anxiety	5.2% 75/1442 • Number of events 75 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	6.0% 88/1457 • Number of events 89 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Psychiatric disorders Insomnia	6.2% 89/1442 • Number of events 89 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	6.0% 87/1457 • Number of events 87 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Atelectasis	17.8% 257/1442 • Number of events 265 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	16.5% 241/1457 • Number of events 252 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Pleural Effusion	22.4% 323/1442 • Number of events 340 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	23.1% 336/1457 • Number of events 352 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	4.1% 59/1442 • Number of events 59 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	5.2% 76/1457 • Number of events 76 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Hypertension	5.1% 74/1442 • Number of events 76 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	5.1% 74/1457 • Number of events 76 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).
Vascular disorders Hypotension	19.4% 280/1442 • Number of events 286 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).	19.2% 280/1457 • Number of events 283 • Up to Post-Operative Day 28 The As-Treated Population was used as the safety population and included all subjects who were assigned randomized treatment and received any amount of study drug (ie, acadesine or placebo).

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media that report any study results).
• Publication restrictions are in place

Restriction type: OTHER