PeriOperative ISchemic Evaluation-2 Trial | NCT01082874

NCT01082874

ID	Type	Description	Link
2009-018173-31	EudraCT Number

Status Module

Name	Class
McMaster University	OTHER

Description Module

Label	Type	Intervention Names
Active Clonidine and Active ASA	Experimental	Drug: Active Clonidine Drug: Active ASA
Active Clonidine and Placebo ASA	Experimental	Drug: Active Clonidine Drug: Placebo ASA
Placebo Clonidine and Active ASA	Experimental	Drug: Placebo Clonidine Drug: Active ASA
Placebo Clonidine and Placebo ASA	Placebo Comparator	Drug: Placebo Clonidine Drug: Placebo ASA

Name	Type	Description	Arm Group Labels	Other Names
Active Clonidine	Drug	Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.	Active Clonidine and Active ASA

Measure	Description	Time Frame
Composite of All-cause Mortality and Nonfatal MI		30 days
All-cause Mortality and Nonfatal MI		1 year

Measure	Description	Time Frame
Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke		30 days
Individual Secondary Outcomes	All-cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, pulmonary emboli, deep venous thrombosis, clinically important atrial fibrillation, amputation, peripheral arterial thrombosis, infection/sepsis, rehospitalization for vascular reasons, length of hospital stay, length of intensive care unit / cardiac care unit (ICU/CCU) stay, and new acute renal failure requiring dialysis.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are undergoing noncardiac surgery;
Are ≥ 45 years of age;
Are expected to require at least an overnight hospital admission after surgery; AND
Fulfill one or more of the following 5 criteria:
- History of coronary artery disease
- History of peripheral vascular disease
- History of stroke
- Undergoing major vascular surgery
- Any 3 of the following 9 criteria:
  - undergoing major surgery (i.e. intraperitoneal, intrathoracic, retroperitoneal or major orthopedic surgery
  - history of congestive heart failure
  - transient ischemic attack
  - diabetes and currently taking an oral hypoglycemic agent or insulin
  - age ≥ 70 years
  - hypertension
  - serum creatinine > 175 µmol/L (> 2.0 mg/dL)
  - history of smoking within 2 years of surgery
  - undergoing urgent/emergent surgery

Exclusion Criteria:

Consumption of ASA within 72 hours prior to surgery
Hypersensitivity or known allergy to ASA or clonidine
Systolic blood pressure < 105 mm Hg
Heart rate < 55 beats per minute in a patient who does not have a permanent pacemaker
Second or third degree heart block without a permanent pacemaker
Active peptic ulcer disease or gastrointestinal bleeding within previous 6 weeks
Intracranial hemorrhage documented by neuro-imaging, in the 6 months prior to randomization. This does not include petechial hemorrhagic transformation of a primary ischemic stroke
Subarachnoid hemorrhage or epidural hematoma unless the event occurred more than 6 months prior to randomization and the offending aneurysm or arterial lesion has been repaired
Drug-eluting coronary stent in the year prior to randomization
Bare-metal coronary stent in the 6 weeks prior to randomization
Thienopyridine (e.g., clopidogrel, ticlopidine, prasugrel) or ticagrelor within 72 hours prior to surgery; or intent to restart a thienopyridine or ticagrelor during the first 7 days post-op; or currently taking an alpha-2 agonist, alpha methyldopa, monoamine oxidase inhibitors or reserpine;
Planned use - during the first 3 days after surgery - therapeutic dose anticoagulation or a therapeutic subcutaneous or intravenous antithrombotic agent
Undergoing intracranial surgery, carotid endarterectomy, or retinal surgery
Not consenting to participate in POISE-2 prior to surgery
Previously enrolled in POISE-2 Trial

Name	Affiliation	Role
P.J. Devereaux, MD, PhD	Population Health Research Institute	Principal Investigator
Salim Yusuf, DPhil	Population Health Research Institute	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
National Coordination Office		Cleveland	Ohio		United States
National Coordination Office

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24679062	Result	Devereaux PJ, Mrkobrada M, Sessler DI, Leslie K, Alonso-Coello P, Kurz A, Villar JC, Sigamani A, Biccard BM, Meyhoff CS, Parlow JL, Guyatt G, Robinson A, Garg AX, Rodseth RN, Botto F, Lurati Buse G, Xavier D, Chan MT, Tiboni M, Cook D, Kumar PA, Forget P, Malaga G, Fleischmann E, Amir M, Eikelboom J, Mizera R, Torres D, Wang CY, VanHelder T, Paniagua P, Berwanger O, Srinathan S, Graham M, Pasin L, Le Manach Y, Gao P, Pogue J, Whitlock R, Lamy A, Kearon C, Baigent C, Chow C, Pettit S, Chrolavicius S, Yusuf S; POISE-2 Investigators. Aspirin in patients undergoing noncardiac surgery. N Engl J Med. 2014 Apr 17;370(16):1494-503. doi: 10.1056/NEJMoa1401105. Epub 2014 Mar 31.
24679061

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Active Clonidine and Active ASA	Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op. Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Active Clonidine and Active ASA	Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op. Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
BG001	Active Clonidine and Placebo ASA	Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op. Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
BG002	Placebo Clonidine and Active ASA	Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op. Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
BG003	Placebo Clonidine and Placebo ASA	Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op. Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
BG004	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Composite of All-cause Mortality and Nonfatal MI

Posted

Number

participants

30 days

ID	Title	Description
OG000	Active Clonidine and Active ASA	Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op. Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
OG001	Active Clonidine and Placebo ASA	Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op. Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
OG002	Placebo Clonidine and Active ASA	Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op. Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
OG003	Placebo Clonidine and Placebo ASA	Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op. Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery

Units	Counts
Participants	OG0002499 OG0012510 OG0022499 OG003

Title

Denominators

Categories

Title	Measurements
	OG000173 OG001194 OG002178 OG003

Primary

All-cause Mortality and Nonfatal MI

Not Posted

1 year

Secondary

Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke

Not Posted

30 days

Secondary

Individual Secondary Outcomes

All-cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, pulmonary emboli, deep venous thrombosis, clinically important atrial fibrillation, amputation, peripheral arterial thrombosis, infection/sepsis, rehospitalization for vascular reasons, length of hospital stay, length of intensive care unit / cardiac care unit (ICU/CCU) stay, and new acute renal failure requiring dialysis.

Not Posted

30 days

Secondary

Composite Outcome by ASA Stratum

Composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis.

Not Posted

30 days

Secondary

Safety Outcomes in ASA Trial

Stroke, congestive heart failure, life-threatening bleeding, and major bleeding.

Not Posted

30 days

Secondary

Safety Outcomes in Clonidine Trial

Stroke, clinically important hypotension, clinically important bradycardia, and congestive heart failure.

Not Posted

30 days

Secondary

Composite Outcome at 1 Year

All-cause mortality, nonfatal MI, and nonfatal stroke.

Not Posted

1 year

Secondary

Individual Secondary Outcomes at 1 Year

All cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, stroke, pulmonary emboli, deep venous thrombosis, amputation, peripheral arterial thrombosis, new diagnosis of cancer, diagnosis of recurrent cancer and rehospitalization for vascular reason.

Not Posted

1 year

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Active Clonidine and Active ASA	Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op. Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery	46	2,499	2,499
EG001	Active Clonidine and Placebo ASA	Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op. Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery	52	2,510	2,510
EG002	Placebo Clonidine and Active ASA	Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op. Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery	45	2,499	2,499
EG003	Placebo Clonidine and Placebo ASA	Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op. Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery	39	2,502	2,502

Serious Adverse Events

Term	Organ System	Statistical Information
Anemia	Blood and lymphatic system disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG0030 events0 affected2,502 at risk
Dissemianted intravascular coagulation	Blood and lymphatic system disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
atrial fibrillation	Cardiac disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Atrial Flutter	Cardiac disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0022 events2 affected2,499 at risk EG003
Myocardial Infarction	Cardiac disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Sinus Arrest	Cardiac disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Supraventricular Tachycardia	Cardiac disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Tachy Arrythymia	Cardiac disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Open Angle Glaucoma	Eye disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Abdominal Distension	Gastrointestinal disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Colitis	Gastrointestinal disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Duodenal Ulcer	Gastrointestinal disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Enterocutaneous Fistula	Gastrointestinal disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Enterovesicle Fistula	Gastrointestinal disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
GI Hemmorhage	Gastrointestinal disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Hernial Eventration	Gastrointestinal disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Ileus	Gastrointestinal disorders	EG0000 events0 affected2,499 at risk EG0013 events3 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Ileus paralytic	Gastrointestinal disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0022 events2 affected2,499 at risk EG003
Intestinal Dilatation	Gastrointestinal disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Intestinal Fistuala	Gastrointestinal disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Intestinal Ischemia	Gastrointestinal disorders	EG0002 events2 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0022 events2 affected2,499 at risk EG003
Intestinal Obstruction	Gastrointestinal disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0022 events2 affected2,499 at risk EG003
Intestinal Perforation	Gastrointestinal disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Large Intestine Perforation	Gastrointestinal disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Mesenteric Vein Thrombosis	Gastrointestinal disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Pneumoretroperitonium	Gastrointestinal disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Rectum hemorrhage	Gastrointestinal disorders	EG0002 events2 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Samll Intestinal Obstruction	Gastrointestinal disorders	EG0001 events1 affected2,499 at risk EG0013 events3 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Volvulus	Gastrointestinal disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Vomiting	Gastrointestinal disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0022 events2 affected2,499 at risk EG003
Device Dislocation	General disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Gait disturbance	General disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Impaired Healing	General disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Multi-organ Failure	General disorders	EG0002 events2 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Pain	General disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Pyrexia	General disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Cholecystitis Acute	Hepatobiliary disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Cirrhosis Alcoholic	Hepatobiliary disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Ischemic Hepatitis	Hepatobiliary disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Portal Vein Thrombosis	Hepatobiliary disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Drug Hypersensitivity	Immune system disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Hypersensitivity	Immune system disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Appendicitis	Infections and infestations	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Cellulitis	Infections and infestations	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Abdominal Wound Dehisence	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Anastomotic Leak	Injury, poisoning and procedural complications	EG0001 events1 affected2,499 at risk EG0013 events3 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Ankle Fracture	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Bladder Injury	Injury, poisoning and procedural complications	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Endotrachial Intubation complication	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Fall	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Fascial Rupture	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Femur Fracture	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Gastrointestinal Anastomotic Leak	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Gastrointestinal Stoma Necrosis	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Humerous Fracture	Injury, poisoning and procedural complications	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Incision Site Hemorrhage	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Incisional Hernia	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Joint Dislocation	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0022 events2 affected2,499 at risk EG003
Lymphatic Duct Injury	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Overdose	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Pancreatic leak	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Postoperative Ileus	Injury, poisoning and procedural complications	EG0002 events2 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0023 events3 affected2,499 at risk EG003
Postoperative Thoracic Procedure Complication	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Subcutaneous Hematoma	Injury, poisoning and procedural complications	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Subdural Hemorrhage	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Wound Evisceration	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Wound Hematoma	Injury, poisoning and procedural complications	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Blood Pressure Systolic Increase	Investigations	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Hemoglobin decrease	Investigations	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Internatinal Normalized Ratio Increased	Investigations	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Liver Functin Test Abnormal	Investigations	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Thoracic Cavity Drainage test Abnormal	Investigations	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Dehydration	Metabolism and nutrition disorders	EG0002 events2 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Electrolyte Imbalance	Metabolism and nutrition disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Hypercalcemia	Metabolism and nutrition disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Hyponatremia	Metabolism and nutrition disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
b-Cell Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Myeloproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Neuroendocrine Carcinoma Metatastic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Transitional Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Cognitive Disorder	Nervous system disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Loss of Consciousness	Nervous system disorders	EG0001 events1 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Peroneal Nerve Palsy	Nervous system disorders	EG0001 events1 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Pre-syncope	Nervous system disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Syncope	Nervous system disorders	EG0001 events1 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0022 events2 affected2,499 at risk EG003
TIA	Nervous system disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Vasculitis Cerebral	Nervous system disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Vocal Cord Paralysis	Nervous system disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Confusinal State	Psychiatric disorders	EG0000 events0 affected2,499 at risk EG0012 events2 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Dilirium	Psychiatric disorders	EG0001 events1 affected2,499 at risk EG0013 events3 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Emotional Distress	Psychiatric disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Mental Disorder	Psychiatric disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Acute Pre-renal Failure	Renal and urinary disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Hematuria	Renal and urinary disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Pelvic-UretericObstruction	Renal and urinary disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Renal Cyst Rupture	Renal and urinary disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Renal Failure	Renal and urinary disorders	EG0001 events1 affected2,499 at risk EG0012 events2 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Renal Failure Acute	Renal and urinary disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0022 events2 affected2,499 at risk EG003
Renal Ischemia	Renal and urinary disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Urinary retention	Renal and urinary disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Actue Respiratory Distress syndrome	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Broncho Spasm	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Chylothorax	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0022 events2 affected2,499 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
pleural Effusion	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0022 events2 affected2,499 at risk EG003
Pulmonary Edema	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Respiratory Arrest	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Respiratory Depression	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected2,499 at risk EG0012 events2 affected2,510 at risk EG0024 events4 affected2,499 at risk EG003
Decubitus Ulcer	Skin and subcutaneous tissue disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Dermatitis Allergic	Skin and subcutaneous tissue disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Rash	Skin and subcutaneous tissue disorders	EG0002 events2 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Subcutaneous Emphysema	Skin and subcutaneous tissue disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Hematoma	Vascular disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0021 events1 affected2,499 at risk EG003
Hypotension	Vascular disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Lymphocele	Vascular disorders	EG0000 events0 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
lymphorrhoea	Vascular disorders	EG0000 events0 affected2,499 at risk EG0011 events1 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003
Orthostatic Hypotension	Vascular disorders	EG0001 events1 affected2,499 at risk EG0010 events0 affected2,510 at risk EG0020 events0 affected2,499 at risk EG003

ID	Term
D048288	Imidazolines
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals