Fondaparinux Trial With Unfractionated Heparin (UFH) Duri... | NCT00790907

Label	Type	Description	Intervention Names
Open label fondaparinux background and standard dose UFH	Experimental	Subjects indicated for PCI and randomized to receive standard dose UFH	Drug: fondaparinux background and standard dose UFH
Open label fondaparinux background and low dose UFH	Experimental	Subjects indicated for PCI and randomized to receive low dose UFH	Drug: Fondaparinux background and low dose heparin
Open label fondapaparinux	Other	Subjects not indicated for PCI and not randomized	Drug: Open label fondaparinux

Name	Type	Description	Arm Group Labels	Other Names
fondaparinux background and standard dose UFH	Drug	Open label fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned glycoprotein [GP] IIb/IIIa inhibitor use: 60 units/kilogram (U/kg); no planned use: 85 U/kg and adjusted based on activated clotting time (ACT) [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.

Measure	Description	Time Frame
Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period	The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site.	Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

Measure	Description	Time Frame
Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30	The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.

Eligibility Module

Eligibility Criteria

The following are inclusion and exclusion criteria for enrollment in the study:

Inclusion Criteria:

Presenting or admitted to hospital with symptoms suspected to represent UA or NSTEMI, i.e., clinical history consistent with new onset, or a worsening pattern of, characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than 5 minutes or requiring sublingual nitro-glycerine for relief of the pain).
Available to be enrolled within 48 hours of the onset of the most recent episode of symptoms.
Planned coronary angiography, with PCI if indicated, within 72 hours of enrollment where possible.
At least two of the three following additional criteria:
Age greater than or equal to 60 years
Troponin T or I or CK-MB above the upper limit of normal for the local institution;
Electrocardiogram (ECG) changes compatible with ischemia, i.e., ST depression at least 1 mm in 2 contiguous leads or T wave inversion > 3 mm or any dynamic ST shift or transient ST elevation.
Written informed consent dated and signed

Exclusion Criteria:

Age < 21 years.
Any contraindication to UFH or fondaparinux
Contraindication for angiography or PCI at baseline
Subjects requiring urgent (<120 minutes) coronary angiography as characterized by those with:
refractory or recurrent angina associated with dynamic ST-deviation
heart failure
life-threatening arrhythmias
hemodynamic instability
Subjects already receiving treatment with enoxaparin (or other LMWH), bivalirudin or UFH for treatment of the qualifying events unless the last administered (intravenous(i.v.) or s.c.) dose was:
≥ 8 hours for low molecular weight heparin (LMWH)
≥60 minutes for bivalirudin
≥90 minutes for unfractionated heparin (UFH)
Hemorrhagic stroke within the last 12 months.
Indication for anti-coagulation other than acute coronary syndrome (ACS) during the index hospitalization.
Pregnancy or women of childbearing potential who are not using an effective method of contraception.
Co-morbid condition with life expectancy less than 6 months.
Currently receiving an experimental pharmacological agent.
Revascularization procedure already performed for the qualifying event.
Severe renal insufficiency (i.e., estimated creatinine clearance <20 ml/min)

Following angiography and confirmation that the subject is to undergo PCI, the subject must also meet all of the following additional criteria in order to be randomised:

Subjects will have received at least 1 dose of open-label fondaparinux
The most recent dose of open-label fondaparinux will not have been more than 24 hours before the start of the PCI procedure.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Ocala	Florida	34471	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
20805623	Background	FUTURA/OASIS-8 Trial Group; Steg PG, Jolly SS, Mehta SR, Afzal R, Xavier D, Rupprecht HJ, Lopez-Sendon JL, Budaj A, Diaz R, Avezum A, Widimsky P, Rao SV, Chrolavicius S, Meeks B, Joyner C, Pogue J, Yusuf S. Low-dose vs standard-dose unfractionated heparin for percutaneous coronary intervention in acute coronary syndromes treated with fondaparinux: the FUTURA/OASIS-8 randomized trial. JAMA. 2010 Sep 22;304(12):1339-49. doi: 10.1001/jama.2010.1320. Epub 2010 Aug 31.
25873729

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
108888	Clinical Study Report	View IPD

ID	Title	Description
FG000	Open-label Fondaparinux 2.5 mg	Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
FG001

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

Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period

The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site.

Intent-to-Treat (ITT) Population: all randomized participants

Posted

Number

participants

Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

ID	Title	Description
OG000	OL Fondaparinux Background + Low Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
OG001	OL Fondaparinux Background + Standard Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.

Units	Counts
Participants	OG0001024 OG0011002

Title

Denominators

Categories

Title	Measurements
	OG00048 OG00158

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic		0.267		Odds Ratio (OR)	0.80			2-Sided	95	0.54	1.19					Superiority or Other

Secondary

Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30

The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.

ITT Population

Posted

Number

participants

Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR

ID	Title	Description
OG000	OL Fondaparinux Background + Low Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
OG001	OL Fondaparinux Background + Standard Dose UFH During PCI

Secondary

Number of Participants With Major Bleeding During the Peri-PCI Period

The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major bleeding, MI and TVR were adjudicated by a blinded CIAC.

ITT Population

Posted

Number

participants

Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

ID	Title	Description
OG000	OL Fondaparinux Background + Low Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
OG001	OL Fondaparinux Background + Standard Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.

Secondary

Number of Participants With Minor Bleeding During the Peri-PCI Period

The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Minor bleeding events were adjudicated by a blinded CIAC.

ITT Population

Posted

Number

participants

Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

ID	Title	Description
OG000	OL Fondaparinux Background + Low Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
OG001	OL Fondaparinux Background + Standard Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.

Secondary

Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period

The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major vascular access site complications included: large hematoma, pseudoaneurysm requiring treatment, arterio-venous fistula, or other vascular procedures related to the access site.

ITT Population

Posted

Number

participants

Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

ID	Title	Description
OG000	OL Fondaparinux Background + Low Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
OG001	OL Fondaparinux Background + Standard Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.

Secondary

Number of Participants With Major PCI-related Procedural Complications

Major PCI-related procedural complications included: abrupt vessel closure, a new angiographic filling defect representing either angiographic thrombus or major dissection with reduced flow, no-reflow phenomenon, or catheter-related thrombus. Investigator reports of catheter-related thrombus were defined as suspected catheter-related thrombus events, and were adjudicated by a blinded CIAC.

ITT Population

Posted

Number

participants

During PCI procedure: immediately after randomization (approximately 10-75 minutes)

ID	Title	Description
OG000	OL Fondaparinux Background + Low Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
OG001	OL Fondaparinux Background + Standard Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.

Secondary

Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30

The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of composite of death, MI, or TVR was performed both during the peri-PCI period and at Day 30. MI and TVR events were adjudicated by a blinded CIAC.

ITT Population

Posted

Number

participants

Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30

ID	Title	Description
OG000	OL Fondaparinux Background + Low Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
OG001	OL Fondaparinux Background + Standard Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.

Secondary

Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30

The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, MI, TVR, definite/probable stent thrombosis, or stroke was performed during the peri-PCI period and at Day 30. MI, TVR, definite/probable stent thrombosis, and stroke events were adjudicated by a blinded CIAC.

ITT Population

Posted

Number

participants

Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30

ID	Title	Description
OG000	OL Fondaparinux Background + Low Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
OG001	OL Fondaparinux Background + Standard Dose UFH During PCI

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected1,209 at risk EG0012 affected1,024 at risk EG0022 affected1,002 at risk
Postoperative wound infection	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 affected1,209 at risk EG0013 affected1,024 at risk EG0020 affected1,002 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected1,209 at risk EG0016 affected1,024 at risk EG0022 affected1,002 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected1,209 at risk EG0011 affected1,024 at risk EG0021 affected1,002 at risk
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Septic shock	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Transient ischemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Anemia of chronic disease	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Anal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Aortic dissection	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0011 affected1,024 at risk EG0021 affected1,002 at risk
Atrial thrombosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Cholangitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Contrast media reaction	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0021 affected1,002 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Extremity necrosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Hepatic encephalophathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Hepatic enzyme increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Impaired healing	General disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Intestinal ischemia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0021 affected1,002 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Esophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Esophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Post procedural infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Thrombophlebitis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0020 affected1,002 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0011 affected1,024 at risk EG0022 affected1,002 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0010 affected1,024 at risk EG0023 affected1,002 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0010 affected1,024 at risk EG0021 affected1,002 at risk
Arthritis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0010 affected1,024 at risk EG0021 affected1,002 at risk
Bronchopneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk
Cardiac tamponade	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0010 affected1,024 at risk EG0021 affected1,002 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk
Cholecystitis infective	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0010 affected1,024 at risk EG0021 affected1,002 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0010 affected1,024 at risk EG0021 affected1,002 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk
Fecaloma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk
Hemolytic anemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk
Esophageal spasm	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0010 affected1,024 at risk EG0021 affected1,002 at risk
Platelet count decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0010 affected1,024 at risk EG0021 affected1,002 at risk
Pleural hemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0010 affected1,024 at risk EG0021 affected1,002 at risk
Pyelonephritis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0010 affected1,024 at risk EG0021 affected1,002 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk
Urosepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0010 affected1,024 at risk EG0021 affected1,002 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected1,209 at risk EG0011 affected1,024 at risk EG0020 affected1,002 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00018 affected1,209 at risk EG00124 affected1,024 at risk EG00228 affected1,002 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00015 affected1,209 at risk EG0010 affected1,024 at risk EG0022 affected1,002 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00015 affected1,209 at risk EG0015 affected1,024 at risk EG0025 affected1,002 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG00013 affected1,209 at risk EG0017 affected1,024 at risk EG0023 affected1,002 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00013 affected1,209 at risk EG00111 affected1,024 at risk EG00216 affected1,002 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00011 affected1,209 at risk EG0019 affected1,024 at risk EG00215 affected1,002 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00010 affected1,209 at risk EG0015 affected1,024 at risk EG0028 affected1,002 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0008 affected1,209 at risk EG0017 affected1,024 at risk EG0021 affected1,002 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0008 affected1,209 at risk EG0016 affected1,024 at risk EG0023 affected1,002 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0007 affected1,209 at risk EG0017 affected1,024 at risk EG0024 affected1,002 at risk
Hypercholesterolemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0007 affected1,209 at risk EG0013 affected1,024 at risk EG0025 affected1,002 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0007 affected1,209 at risk EG0016 affected1,024 at risk EG00210 affected1,002 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 affected1,209 at risk EG0014 affected1,024 at risk EG0025 affected1,002 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 affected1,209 at risk EG0019 affected1,024 at risk EG0025 affected1,002 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 affected1,209 at risk EG00111 affected1,024 at risk EG0022 affected1,002 at risk
Diarrhea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0019 affected1,024 at risk EG0027 affected1,002 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected1,209 at risk EG0014 affected1,024 at risk EG00210 affected1,002 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0004 affected1,209 at risk EG0011 affected1,024 at risk EG0026 affected1,002 at risk
Hematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected1,209 at risk EG0016 affected1,024 at risk EG0023 affected1,002 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected1,209 at risk EG0012 affected1,024 at risk EG0027 affected1,002 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected1,209 at risk EG0010 affected1,024 at risk EG0027 affected1,002 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 affected1,209 at risk EG0016 affected1,024 at risk EG0022 affected1,002 at risk

ID	Term
D054058	Acute Coronary Syndrome
D000789	Angina, Unstable
D000072658	Non-ST Elevated Myocardial Infarction

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D000787	Angina Pectoris
D002637	Chest Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009203	Myocardial Infarction
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D009336	Necrosis

ID	Term
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates

ID	Title	Description
BG000	Open-label Fondaparinux 2.5 mg	Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
BG001	OL Fondaparinux Background + Low Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
BG002	OL Fondaparinux Background + Standard Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Open-label Fondaparinux 2.5 mg	Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized	48	1,209	117	1,209
EG001	OL Fondaparinux Background + Low Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.	28	1,024	100	1,024
EG002	OL Fondaparinux Background + Standard Dose UFH During PCI	OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.	20	1,002	113	1,002