SPIRIT PRIME Clinical Trial | NCT00916370

Label	Type	Description	Intervention Names
Core size registry (CSR)	Experimental	Core size indicates the range of diameters of the stents used.	Device: Core size Xience Prime
Long lesion registry (LLR)	Experimental	Use of long lesion stents.	Device: Xience Prime Long Lesion (LL)

Name	Type	Description	Arm Group Labels	Other Names
Core size Xience Prime	Device	Core size includes a range of stent sizes.	Core size registry (CSR)

Measure	Description	Time Frame
Target Lesion Failure (TLF)	The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.	1 year
Target Lesion Failure (TLF)	The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.	2 years
Target Lesion Failure (TLF)	The composite rate of: Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.	3 years

Measure	Description	Time Frame
Procedure Time	Procedure time is defined as time between insertion and withdrawal of guide catheter.	From insertion to withdrawal of guide catheter
Device Success (Lesion Basis)	Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must be at least 18 years of age.
Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
Subject must agree to undergo all protocol-required follow-up procedures.
Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

One or two de novo target lesions each in a different epicardial vessel.
If there are two target lesions, both lesions must satisfy the angiographic eligibility criteria for that registry.

o Multiple focal de novo lesions in a target vessel that can be covered by a single stent are allowed.
The target lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of:
- ≥ 2.25 mm and ≤ 4.25 mm for treatment by the core size XIENCE PRIME EECS
- ≥ 2.5 mm and ≤ 4.25 mm for treatment by the XIENCE PRIME LL EECS
Target lesion(s) must be located in a native coronary artery with length by visual estimation of:
- ≤ 22 mm for treatment by the core size XIENCE PRIME EECS
- > 22 mm and ≤ 32 mm for treatment by the XIENCE PRIME LL EECS

Exclusion Criteria:

Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.
The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
Subject has received coronary brachytherapy in any epicardial vessel (target or non target).
Subject has received any organ transplant or is on a waiting list for any organ transplant.
Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.
Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.
Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.
Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
Subject has known renal insufficiency (examples being but not limited to estimated glomerular filtration rate (eGFR) < 60 ml/kg/m2, serum creatinine level ≥ 2.5 mg/dL, or on dialysis).
Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
Subject is currently participating in another clinical study that has not yet completed its primary endpoint.
Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.

Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft.
Target lesion involving a bifurcation with a side branch ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guide wire, or side branch requiring dilatation.
Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.
Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.
Restenotic target lesion.
Aorto-ostial target lesion (within 3 mm of the aorta junction).
Target lesion is in a left main location.
Target lesion located within 2 mm of the origin of the LAD or LCX.
Extreme angulation (≥ 90 °) or excessive tortuosity (≥ two 45° angles) proximal to or within the lesion.
Heavy calcification proximal to or within the target lesion.
Target vessel contains thrombus as indicated in the angiographic images.
Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon).
Target vessel is previously treated with any type of PCI (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure.
Non-target vessel is previously treated with any type of PCI < 90 days prior to the index procedure.
Additional clinically significant lesion(s) (e.g. %DS ≥ 50%) in a target vessel or side branch for which PCI may be required < 90 days after the index procedure.

Name	Affiliation	Role
Marco Costa, MD, PhD	University Hospitals Cleveland Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Hospital		Fairhope	Alabama	36532	United States
Scottsdale Healthcare

Results Section

Participant Flow Module

ID	Title	Description
FG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
FG001	Long Lesion Registry	Use of long lesion stents.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Target Lesion Failure (TLF)

The composite rate of:

Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

The number of participants analyzed is based on FAS population, defined as subjects who have received the investigational study device and excludes subjects who are truly lost-to-follow-up, defined as subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI, all revascularization, respectively).

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000399 OG001104

Title

Denominators

Categories

Title	Measurements
	OG0004.5 OG0017.7

Secondary

Procedure Time

Procedure time is defined as time between insertion and withdrawal of guide catheter.

The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Therefore, the final analysis contained 403 ITT CSR subjects and 106 ITT LLR subjects.

Posted

Mean

Standard Deviation

Minutes

From insertion to withdrawal of guide catheter

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Device Success (Lesion Basis)

Device success is defined as achievement of a final in-stent residual diameter stenosis of < 50% (by QCA).

Posted

Number

percentage of lesions

From the start of index procedure to end of index procedure

Lesions

Participants

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Procedural Success (Subject Basis)

Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA). Per Protocol.

The analysis was done to include only subjects with post index procedure cardiac enzyme data in window (between 8 hours post index procedure and hospital discharge). Out of these subjects, 2 in the CSR and 1 in the LLR did not have QCA data and therefore were excluded. So, the final analysis contained 401 ITT CSR subjects and 105 ITT LLR subjects.

Posted

Number

percentage of participants

From the start of index procedure to end of index procedure

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Death (Cardiac, Vascular, Non-cardiovascular)

Posted

Number

percentage of participants

In-hospital is less than or equal to 7 days post index procedure

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Death (Cardiac, Vascular, Non-cardiovascular)

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Death (Cardiac, Vascular, Non-cardiovascular)

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Death (Cardiac, Vascular, Non-cardiovascular)

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Death (Cardiac, Vascular, Non-cardiovascular)

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Death (Cardiac, Vascular, Non-cardiovascular)

Posted

Number

percentage of participants

3 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)

Per Protocol

Posted

Number

percentage of participants

In-hospital is defined as hospitalization less than or equal to 7 days post index procedure.

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)

Per Protocol

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)

Per Protocol

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)

Per Protocol

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)

Per Protocol

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Target Vessel-Myocardial Infarction (TV-MI) - Q-wave and Non Q-wave (Defined as MI Not Clearly Attributable to a Non-target Vessel)

Per Protocol

Posted

Number

percentage of participants

3 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Non-target Vessel MI (Q-wave, Non Q-wave)

Per Protocol

Posted

Number

percentage of participants

In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Non-target Vessel MI (Q-wave, Non Q-wave)

Per Protocol

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Non-target Vessel MI (Q-wave, Non Q-wave)

Per Protocol

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Non-target Vessel MI (Q-wave, Non Q-wave)

Per Protocol

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Non-target Vessel MI (Q-wave, Non Q-wave)

Per Protocol

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Non-target Vessel MI (Q-wave, Non Q-wave)

Per Protocol

Posted

Number

percentage of participants

3 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Clinically Indicated-Target Lesion Revascularization

Posted

Number

percentage of participants

In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Clinically Indicated-Target Lesion Revascularization

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Clinically Indicated-Target Lesion Revascularization

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Clinically Indicated-Target Lesion Revascularization

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Clinically Indicated-Target Lesion Revascularization

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Clinically Indicated-Target Lesion Revascularization

Posted

Number

percentage of participants

3 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)

Posted

Number

percentage of participants

In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Clinically Indicated Target Vessel Revascularization (TVR = TLR and Non-TLR in TV)

Posted

Number

percentage of participants

3 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All TLR (CI and Non-CI)

Posted

Number

percentage of participants

In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All TLR (CI and Non-CI)

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All TLR (CI and Non-CI)

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All TLR (CI and Non-CI)

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All TLR (CI and Non-CI)

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All TLR (CI and Non-CI)

Posted

Number

percentage of participants

3 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All TVR (CI and Non-CI)

Posted

Number

percentage of participants

In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All TVR (CI and Non-CI)

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All TVR (CI and Non-CI)

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All TVR (CI and Non-CI)

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All TVR (CI and Non-CI)

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All TVR (CI and Non-CI)

Posted

Number

percentage of participants

3 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Coronary Revascularization (TVR and Non-TVR)

Posted

Number

percentage of participants

In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Coronary Revascularization (TVR and Non-TVR)

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Coronary Revascularization (TVR and Non-TVR)

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Coronary Revascularization (TVR and Non-TVR)

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Coronary Revascularization (TVR and Non-TVR)

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Coronary Revascularization (TVR and Non-TVR)

Posted

Number

percentage of participants

3 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Cardiac Death/All MI

Posted

Number

percentage of participants

In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Cardiac Death/ All MI

Per Protocol

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Cardiac Death/All MI

Per Protocol

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Cardiac Death/All MI

Per Protocol

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Cardiac Death/All MI

Per Protocol

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Cardiac Death/All MI

Per Protocol

Posted

Number

percentage of participants

3 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Cardiac Death/ All MI/CI-TLR

Posted

Number

percentage of participants

in-hospital

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Cardiac Death/ All MI/CI-TLR

Per Protocol

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Cardiac Death/ All MI/CI-TLR

Per Protocol

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Cardiac Death/ All MI/CI-TLR

Per Protocol

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Cardiac Death/ All MI/CI-TLR

Per Protocol

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Cardiac Death/ All MI/CI-TLR

Per Protocol

Posted

Number

percentage of participants

3 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Death/All MI/All Coronary Revascularization

Per Protocol

Posted

Number

percentage of participants

In-hospital is defined as hospitalization less than or equal to 7 days post index procedure

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Death/All MI/All Coronary Revascularization

Per Protocol

Posted

Number

percentage of participants

30 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Death/All MI/All Coronary Revascularization

Per Protocol

Posted

Number

percentage of participants

180 days

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Death/All MI/All Coronary Revascularization

Per Protocol

Posted

Number

percentage of participants

1 year

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Death/All MI/All Coronary Revascularization

Per Protocol

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

All Death/All MI/All Coronary Revascularization

Per Protocol

Posted

Number

percentage of participants

3 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis

Per protocol and per Academic Research Consortium (ARC, definite/probable)

Posted

Number

percentage of participants

Acute (≤1 day)

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis

Per protocol and per ARC

Posted

Number

percentage of participants

Subacute (>1 - 30 days)

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis

Per protocol and per ARC

Posted

Number

percentage of participants

Acute/Subacute (0 - 30 days)

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis

Per protocol and per ARC

Posted

Number

percentage of participants

Late (31 - 393 days)

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis

Per protocol

Posted

Number

percentage of participants

Late (31 - 758 days)

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis

Per ARC, definite and probable

Posted

Number

percentage of participants

Very Late (394 - 758 days)

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis

Per protocol

Posted

Number

percentage of participants

Late (31 - 1123 days)

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis

Per ARC, definite and probable

Posted

Number

percentage of participants

Very Late (394 - 1123 days)

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Primary

Target Lesion Failure (TLF)

The composite rate of:

Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Primary

Target Lesion Failure (TLF)

The composite rate of:

Cardiac Death Target Vessel Myocardial Infarction (TV-MI) and Clinically Indicated Target Lesion Revascularization (CI-TLR) per protocol.

Posted

Number

percentage of participants

3 years

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	Use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis

Per protocol and per ARC

Posted

Number

percentage of participants

Overall (0-393 days)

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis

Per protocol

Posted

Number

percentage of participants

Overall (0-758 days)

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis

Per ARC, definite and probable

Posted

Number

percentage of participants

Overall (0-758 days)

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis

Per protocol

Posted

Number

percentage of participants

Overall (0 - 1123 days)

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Secondary

Stent Thrombosis

Per ARC, definite and probable

Posted

Number

percentage of participants

Overall (0 - 1123 days)

ID	Title	Description
OG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
OG001	Long Lesion Registry	use of long lesion stents.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG00013 events12 affected412 at risk EG0014 events3 affected110 at risk
Angina pectoris	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG00083 events59 affected412 at risk EG00120 events16 affected110 at risk
Angina unstable	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG00021 events14 affected412 at risk EG0016 events6 affected110 at risk
Aortic valve disease	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG00010 events9 affected412 at risk EG0012 events2 affected110 at risk
Atrioventricular block	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0011 events1 affected110 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Bradycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Cardiac arrest	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG00010 events8 affected412 at risk EG0012 events2 affected110 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Chest pain	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Coronary artery disease	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0008 events7 affected412 at risk EG0010 events0 affected110 at risk
Coronary artery dissection	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0003 events3 affected412 at risk EG0012 events2 affected110 at risk
Coronary artery embolism	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Coronary artery perforation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0011 events1 affected110 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0004 events4 affected412 at risk EG0011 events1 affected110 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Coronary ostial stenosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Hypertrophic cardiomyopathy	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0003 events2 affected412 at risk EG0010 events0 affected110 at risk
Microvascular angina	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Myocardial infarction	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0003 events3 affected412 at risk EG0013 events3 affected110 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Palpitations	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Pericarditis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Post procedural myocardial infarction	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Tachycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0011 events1 affected110 at risk
Asthenia	General disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Catheter site haemorrhage	General disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Non-cardiac chest pain	General disorders	MedDRA (11.0)	Systematic Assessment		EG00030 events23 affected412 at risk EG0016 events6 affected110 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Device failure	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
In-stent arterial restenosis	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment		EG0002 events1 affected412 at risk EG0011 events1 affected110 at risk
In-stent coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0013 events2 affected110 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Lead dislodgement	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Stent occlusion	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Thrombosis in device	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Other injuries	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	Other injuries consists of all the Preferred Terms (PT) which were not in Administration site reactions and Procedural and device related injuries and classifications High-Level Group Terms category for the corresponding System Organ Class (SOC)	EG0005 events5 affected412 at risk EG0011 events1 affected110 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Cerebral infarction	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Convulsion	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0012 events1 affected110 at risk
Dementia	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Dizziness	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0003 events2 affected412 at risk EG0011 events1 affected110 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Migraine	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Multiple sclerosis	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Occipital neuralgia	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Paraesthesia	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Presyncope	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Syncope	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0008 events7 affected412 at risk EG0010 events0 affected110 at risk
Syncope vasovagal	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0011 events1 affected110 at risk
Tremor	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Vertigo	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Vertigo positional	Nervous system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0011 events1 affected110 at risk
Other renal and urinary disorders	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	Other renal and urinary disorders consist of all the PTs which were not in Acute renal failure for the corresponding SOC.	EG0007 events6 affected412 at risk EG0013 events3 affected110 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment		EG0003 events2 affected412 at risk EG0010 events0 affected110 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment		EG0007 events7 affected412 at risk EG0012 events2 affected110 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment		EG0003 events3 affected412 at risk EG0010 events0 affected110 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0011 events1 affected110 at risk
Wegeners granulomatosis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Arteriosclerosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0004 events3 affected412 at risk EG0010 events0 affected110 at risk
Carotid artery stenosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0004 events4 affected412 at risk EG0011 events1 affected110 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0004 events4 affected412 at risk EG0010 events0 affected110 at risk
Duodenal ulcer haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Epistaxis	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Femoral artery occlusion	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0013 events2 affected110 at risk
Gastrointestinal haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0003 events3 affected412 at risk EG0010 events0 affected110 at risk
Haematoma	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Haemoptysis	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Hypertension	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0013 events3 affected110 at risk
Hypertensive crisis	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Hypotension	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Iliac artery stenosis	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Intermittent claudication	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0011 events1 affected110 at risk
Malignant hypertension	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Mallory-Weiss syndrome	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0012 events1 affected110 at risk
Peripheral artery dissection	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0012 events2 affected110 at risk
Post procedural haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Pulmonary embolism	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Scrotal haematocoele	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Subarachnoid haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Subdural haematoma	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Upper gastrointestinal haemorrhage	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Vascular pseudoaneurysm	Vascular disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0011 events1 affected110 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment		EG0006 events6 affected412 at risk EG0011 events1 affected110 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0011 events1 affected110 at risk
Hypercoagulation	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Barretts oesophagus	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Colitis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Exomphalos	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Pharyngoesophageal diverticulum	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Abscess	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Abscess limb	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0012 events1 affected110 at risk
Acute sinusitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Breast abscess	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Bronchitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0004 events4 affected412 at risk EG0010 events0 affected110 at risk
Cellulitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0013 events2 affected110 at risk
Clostridial infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Diverticulitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0002 events1 affected412 at risk EG0010 events0 affected110 at risk
Endocarditis	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Endocarditis bacterial	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Gastroenteritis	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Influenza	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Lobar pneumonia	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0012 events1 affected110 at risk
Localised infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Osteomyelitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Pneumonia	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0003 events3 affected412 at risk EG0013 events3 affected110 at risk
Post procedural cellulitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Rectal abscess	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Scrotal abscess	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Sepsis	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Septic shock	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Serratia infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Sialoadenitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0002 events2 affected412 at risk EG0010 events0 affected110 at risk
Wound infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Cardiac enzymes increased	Investigations	MedDRA (11.0)	Systematic Assessment		EG0003 events3 affected412 at risk EG0011 events1 affected110 at risk
Electrocardiogram ST segment depression	Investigations	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Haematocrit decreased	Investigations	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Pedal pulse decreased	Investigations	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment		EG0005 events4 affected412 at risk EG0011 events1 affected110 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment		EG0004 events3 affected412 at risk EG0010 events0 affected110 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0011 events1 affected110 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment		EG00011 events10 affected412 at risk EG0016 events5 affected110 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment		EG0002 events1 affected412 at risk EG0010 events0 affected110 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Salivary gland cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment		EG0002 events1 affected412 at risk EG0010 events0 affected110 at risk
Small intestine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Alcoholism	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Bipolar disorder	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Confusional state	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0011 events1 affected110 at risk
Intentional overdose	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Major depression	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment		EG0003 events3 affected412 at risk EG0010 events0 affected110 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment		EG0000 events0 affected412 at risk EG0011 events1 affected110 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment		EG0002 events1 affected412 at risk EG0010 events0 affected110 at risk
Knee operation	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment		EG0001 events1 affected412 at risk EG0010 events0 affected110 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG000114 events89 affected412 at risk EG00124 events20 affected110 at risk
Coronary artery dissection	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00011 events11 affected412 at risk EG0019 events9 affected110 at risk
Catheter site haematoma	General disorders	MedDRA (11.0)	Systematic Assessment	EG00021 events21 affected412 at risk EG0015 events5 affected110 at risk
Fatigue	General disorders	MedDRA (11.0)	Systematic Assessment	EG00025 events25 affected412 at risk EG0013 events3 affected110 at risk
Non-cardiac chest pain	General disorders	MedDRA (11.0)	Systematic Assessment	EG00077 events71 affected412 at risk EG00114 events13 affected110 at risk
Headache	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00027 events27 affected412 at risk EG0016 events3 affected110 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG00027 events26 affected412 at risk EG0013 events3 affected110 at risk
Hypertension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG00012 events11 affected412 at risk EG0016 events6 affected110 at risk
Catheter site haemorrhage	General disorders	MedDRA (11.0)	Systematic Assessment	EG00016 events15 affected412 at risk EG0016 events6 affected110 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00028 events24 affected412 at risk EG0017 events7 affected110 at risk

ID	Term
D017202	Myocardial Ischemia
D023921	Coronary Stenosis
D003327	Coronary Disease
D003324	Coronary Artery Disease
D023903	Coronary Restenosis

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

ID	Title	Description
BG000	Core Size Registry	Core size indicates the range of diameters of the stents used.
BG001	Long Lesion Registry	Use of long lesion stents.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Core Size Registry	Core size indicates the range of diameters of the stents used.			203	412	222	412
EG001	Long Lesion Registry	Use of long lesion stents.			49	110	51	110