The Elixir Bioadaptor vs. The Onyx Stent in De Novo Nativ... | NCT04192747

Label	Type	Description	Intervention Names
Elixir Bioadaptor (ELX1805J)	Experimental	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length	Device: Percutaneous Coronary Intervention
Medtronic Resolute Onyx Stent	Active Comparator	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length	Device: Percutaneous Coronary Intervention

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous Coronary Intervention	Device	Percutaneous coronary intervention of de novo native coronary artery lesions	Elixir Bioadaptor (ELX1805J) Medtronic Resolute Onyx Stent

Measure	Description	Time Frame
Percentage of Participants With Target Lesion Failure (TLF)	The primary endpoint of the BIOADAPTOR RCT is Target Lesion Failure (TLF), which is a composite endpoint defined as cardiac death, target-vessel MI, and Clinically-Indicated TLR	12 Months

Measure	Description	Time Frame
Percentage of Participants With Target Lesion Failure (TLF)	TLF is a composite endpoint defined as cardiovascular death, target-vessel MI, and Clinically-Indicated TLR	Through 12 months post-procedure
Percentage of Participants With Patient Oriented Clinical Endpoint

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

General Inclusion Criteria

Patients who meet all of the following criteria are eligible:

Patient must be ≥ 20 years of age.
Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or electrocardiogram (ECG) changes consistent with ischemia)
Patients who are able to take dual anti-platelet therapy for 1 year following the index procedure and anticoagulants prior to/during the index procedure.
The subject is an acceptable candidate for Percutaneous Transluminal Coronary Angioplasty (PTCA), stenting, and emergent Coronary Artery Bypass Graft (CABG) surgery.
The subject or subject's legally authorized representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board or Ethics Committee of the respective clinical site.
Women of childbearing potential with a negative pregnancy test within 7 days and women who are not pregnant or nursing
Patient must agree to undergo all clinical study required follow up visits, angiograms, and imaging testing
Patient must agree not to participate in any other clinical research study for a period of one year following the index procedure
Target lesion(s) must be de novo and located in a native coronary artery with a vessel mean diameter of ≥ 2.25 and ≤ 4.0 mm.
Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of > 1. When two target lesions are treated, they must be located in separate major epicardial vessels
visually estimated target lesion length is ≤ 34mm mm and must be able to be covered by a single 14/15/18/23/28/32/38 mm ELX1805J stent and have at least 2 mm of healthy vessel on either side Or
The visually estimated target lesion length is ≤ 34mm mm and must be able to be covered by a single 15/18/22/30/34/38 mm ZES stent respectively and have at least 2 mm of healthy vessel on either side.
The lesion(s) must be successfully pre-dilated prior to enrollment Mandatory pre-dilatation includes the use of 2 orthogonal views to confirm lesion inclusion and exclusion criteria and successful pre-dilatation defined as balloon inflation without waist and a lumen diameter no less than 0.5 mm smaller than the vessel diameter.
Percutaneous intervention of lesions in a non-target vessel if:
- Not part of a another clinical investigation
- ≥ 30 days prior to the study index procedure
- ≥ 6 months after the study index procedure (planned)
Percutaneous intervention of lesions located in the target vessel if:
- Not part of a clinical investigation
- ≥ 6 months prior to the study index procedure
- >12 months after the study index procedure (planned)
- Previous intervention was distal to and >10 mm from the target lesion

Exclusion Criteria:

The patient was diagnosed with an acute myocardial infarction within the past 72 hours and the CK and CKMB have not returned to normal (or cTn >15x ULN) and the patient is experiencing clinical symptoms indicative of ongoing ischemia
Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, cobalt, nickel, chromium, molybdenum, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated
Patients with a history of allergic reaction or serious hypersensitivity to drugs exhibiting interactions with sirolimus, zotarolimus, everolimus, tacrolimus, temsirolimus, biolimus and other rapamycin, derivatives or analogues) or similar drugs
Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors.
Patient presenting with chronic (permanent) atrial or ventricular arrhythmia or current unstable ventricular arrhythmias
Patient has a known left ventricular ejection fraction (LVEF) < 30%
Patient has received a heart or other organ transplant or is on a waiting list for any organ transplant
Patient has a malignancy that is not in remission.
Patient is receiving immunosuppression therapy other than steroids and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) that cannot be stopped and restarted according to local hospital standard procedures.
Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected to have cirrhosis of Child-Pugh ≥ Class B within 7 days before study procedure
Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL within 7 days before study procedure, or patient on dialysis)
Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
Patient has had a significant GI or urinary bleed within the past six months
Patient has severe symptomatic heart failure (i.e., NYHA class IV)
Patient has a medical condition that precludes safe 6 French sheath insertion
Patient has other medical illness or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
Patient is already participating in another clinical research study which has not reached the primary endpoint (long-term follow-up is not an exclusion)
Other patients whom primary investigator or subinvestigator determined to be ineligible for this clinical study
Patients with bypass graft to the target vessel or lesion is located in a bypass graft
Patients with stent implanted within 10 mm of proximal or distal end of target lesion
Patients with a target lesion involving a bifurcation of which the side branch will be jailed by the struts and:
- Side branch ≥ 2.5 mm in diameter,
- Side branch requiring predilatation (including Kissing Balloon Technique), or
- Side branch has an ostial lesion or lesion with > 50% stenosis
Patients suspected or confirmed with the QCA analysis of having stenotic lesion of more than 50% in target vessel in addition to target lesion
Patients with target lesion in ostia located within 5 mm of origin of LAD, LCX or RCA
Patients with stenotic lesion in left main trunk
Patients with target lesion that is a chronic total occlusion (CTO) or ≤ TIMI 1 coronary flow in the target vessel
Patients with target vessel that contains thrombus as indicated in pre-procedure angiographic, IVUS or OCT images
Excessive tortuosity ≥ two 45° angles or extreme angulation (≥ 90°) proximal to or within the target lesion
Patients with target vessel that has moderate to severe calcification that prevents complete angioplasty balloon (POBA with non-compliant balloon, or scoring balloon,) inflation or requires other devices such as rotational atherectomy, rotoblator.
Patients with dissection of Grade A or B that cannot be covered (including 2mm distal to the dissection) with a single study device or with dissection of Grade C or higher
Patients with 2 or more target lesions on 1 branch or target lesions on 3 branches that need to be treated during study procedure
Target lesion involves a myocardial bridge

Name	Affiliation	Role
Shigeru Saito, MD	Chief Director, Shonan Kamakura General Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
AZ Middelheim Hospital		Antwerp			Belgium
AZ Sint Jan Brugge

PubMed Identifier	Type	Citation	Retractions
40057888	Derived	Saito S, Bennett J, Nef HM, Webster M, Namiki A, Takahashi A, Kakuta T, Yamazaki S, Shibata Y, Scott D, Vrolix M, Menon M, Mollmann H, Werner N, Neylon A, Mehmedbegovic Z, Smits PC, Morice MC, Verheye S; BIOADAPTOR-RCT Collaborators. Percutaneous Coronary Treatment With Bioadaptor Implant vs Drug-Eluting Stent: 2-Year Outcomes From BIOADAPTOR RCT. JACC Cardiovasc Interv. 2025 Apr 28;18(8):988-997. doi: 10.1016/j.jcin.2025.01.426. Epub 2025 Feb 26.
39098754

ID	Title	Description
FG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
FG001	Medtronic Resolute Onyx Stent

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 20, 2022

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

Percentage of Participants With Target Lesion Failure (TLF)

The primary endpoint of the BIOADAPTOR RCT is Target Lesion Failure (TLF), which is a composite endpoint defined as cardiac death, target-vessel MI, and Clinically-Indicated TLR

Posted

Number

95% Confidence Interval

percentage of participants

12 Months

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000221 OG001215

Title

Denominators

Categories

Title	Measurements
	OG0001.81(.50 to 4.57) OG0012.79(1.03 to 5.97)

Secondary

Percentage of Participants With Target Lesion Failure (TLF)

TLF is a composite endpoint defined as cardiovascular death, target-vessel MI, and Clinically-Indicated TLR

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post-procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Patient Oriented Clinical Endpoint

Overall cardiovascular outcomes from the patient's perspective. This endpoint is a composite endpoint that includes all-cause mortality (cardiac and non-cardiac), stroke, MI (target vessel and non-target vessel) and revascularization (target vessel and non-target vessel)

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants

Secondary

Percentage of Participants With Composite of All-cause Mortality

A composite of all-cause mortality, MI (target vessel or non-target vessel) and revascularization (target vessel or non-target vessel)

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post-procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants

Secondary

Percentage of Participants With Composite of Cardiovascular Death, TVMI and ID-TVR Revascularization

Composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR)

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Cardiovascular Death, Stroke, MI and Revascularization

Composite of cardiovascular death, stroke, MI (target vessel and non-target vessel) and revascularization (target vessel and non-target vessel)

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Cardiovascular Death, MI and Revascularization

Composite of cardiovascular death, MI (target vessel or non-target vessel) and revascularization (target vessel or non-target vessel)

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Clinically Indicated Target Lesion Revascularization (CI-TLR)

Number of Patients with Clinically Indicated Target Lesion Revascularization (CI-TLR)

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post-procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Target Lesion Revascularization (TLR)

Target lesion revascularization

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post-procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Target Vessel Revascularization (TVR)

Re-PCI or CABG of the target vessel due to in-segment restenosis or other complications

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post-procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Clinically Indicated TVR (CI-TVR)

Re-PCI or CABG in the target vessel due to restenosis or other complications

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post-procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Revascularization (Target Vessel or Non-target Vessel)

Revascularization of the target vessel or non-target vessel due to in-segment restenosis or other complications

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants

Secondary

Percentage of Participants With Q-wave MI

CK post procedure is twice the upper limit of the reference value or higher, with new pathological Q-wave on 2 or more contiguous ECG leads and if CK-MB is measured, CK-MB is positive, if no CKMB then troponin is positive.

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post-procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants

Secondary

Percentage of Participants With Non Q-wave MI

CK post procedure is twice the upper limit of the reference value or higher, without new pathological Q-waves. If CK-MB is measured, CK-MB is positive, if no CKMB then troponin is positive.

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post-procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants

Secondary

Percentage of Participants With MI (Target Vessel or Non-target Vessel)

MI is defined as per the Academic Research Consortium (ARC-2) criteria

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Target Vessel MI

MI is defined as per the Academic Research Consortium (ARC-2) criteria

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With All-cause Mortality

As defined per the Academic Research Consortium (ARC-2) criteria

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post-procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Cardiovascular Death

As defined as per the Academic Research Consortium (ARC-2) criteria

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Composite of Cardiovascular Death or Target Vessel MI

Target Vessel Related Death or MI

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Composite of All-cause Death or MI

Target vessel or non-target vessel related death or MI

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post-procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Composite of All-cause Death, MI (Target Vessel or Non-target Vessel), or TVR

Any Death, any MI and any Target Vessel Revascularization

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post-procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Composite of Probable or Definite Stent Thrombosis

Defined as per the Academic Research Consortium (ARC-2) criteria

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post-procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Probable Stent Thrombosis

Defined as per the Academic Research Consortium (ARC-2) criteria

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months post-procedure

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Definite Stent Thrombosis

Defined as per the Academic Research Consortium (ARC-2) criteria

The denominator reflects the number of evaluable participants for the outcome measure

Posted

Number

95% Confidence Interval

percentage of participants

Through 12 months

ID	Title	Description
OG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
OG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0012 affected222 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Angina pectoris	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected223 at risk EG0015 affected222 at risk
Angina unstable	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected223 at risk EG0013 affected222 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Cardiac failure	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0012 affected222 at risk
Chest discomfort	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Chest pain	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected223 at risk EG0011 affected222 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Dyspnoea	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Myopericarditis	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Prinzmetal angina	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected222 at risk
Thoracic pain	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Congenital spinal stenosis	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Cataract	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Eyelid ptosis	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0013 affected222 at risk
Barrett"s oesophagus	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected222 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Diverticulum itestial haemorrhagic	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Gastritis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Gastroesophageal Disease	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Gastrointestinal angiectasia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Gastrointestinal Hemmorhages	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0012 affected222 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Large Intestine Polyp	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected222 at risk
Melanea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0012 affected222 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Pharyngo-oesophageal diverticulum	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Toothache	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Chest discomfort	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0012 affected222 at risk
Chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0008 affected223 at risk EG00113 affected222 at risk
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
General physical health deterioration	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Influenza like illness	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Malaise	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Non-cardiac chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0013 affected222 at risk
Peripheral swelling	General disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Vascular stent stenosis	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected222 at risk
Vascular stent thrombosis	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected222 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Contrast media allergy	Immune system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Asymptomatic COVID-19	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Bronchitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
COVID-19	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0008 affected223 at risk EG00113 affected222 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Coronavirus infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Herpes dermatitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Herpes zoster	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0012 affected222 at risk
Nasopharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Pyelonephritis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Sinusitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Urosepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Viral infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Contrast media reaction	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0005 affected223 at risk EG0015 affected222 at risk
Coronary artery dissection	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0005 affected223 at risk EG00110 affected222 at risk
Coronary artery occlusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0012 affected222 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0012 affected222 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Foreign body in eye	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Periprocedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0013 affected222 at risk
Post procedural hypotension	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Postoperative delirium	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0012 affected222 at risk
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Reperfusion injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Vascular access site bruising	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Vascular access site complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Vascular access site haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected222 at risk
Vascular access site haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0012 affected222 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Vessel perforation	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected222 at risk
Vessel puncture site haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Vessel puncture site haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Vessel puncture site swelling	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Angiogram	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Blood pressure increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Blood uric acid increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
ECG signs of myocardial ischaemia	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Hepatic enzyme increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Magnetic resonance imaging abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Myocardial necrosis marker increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0009 affected223 at risk EG0014 affected222 at risk
Prostatic specific antigen increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Troponin I increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Troponin increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Ureteroscopy	Investigations	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0016 affected222 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected223 at risk EG0011 affected222 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0013 affected222 at risk
Greater trochanteric pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0013 affected222 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Gliosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Lip neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Oesophageal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Oesophageal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Amnesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected222 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Lethargy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Loss of consciousness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Memory impairment	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Paraesthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0012 affected222 at risk
Parkinson's disease	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Partial seizures	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Presyncope	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0012 affected222 at risk
Spinal claudication	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Anxiety	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Insomnia	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected223 at risk EG0012 affected222 at risk
Calculus urinary	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Haematuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0014 affected222 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Renal cyst	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0012 affected222 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected223 at risk EG0015 affected222 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected223 at risk EG0016 affected222 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected223 at risk EG0012 affected222 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected222 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected222 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0012 affected222 at risk
Craniotomy	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Finger amputation	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Keratoplasty	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Skin cyst excision	Surgical and medical procedures	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Acute coronary syndrome	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Aneurysm arteriovenous	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Haematoma	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected223 at risk EG0013 affected222 at risk
Hypertensive crisis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected223 at risk EG0010 affected222 at risk
Iliac artery stenosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Intermittent claudication	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Internal haemorrhage	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected223 at risk EG0011 affected222 at risk
Peripheral vein thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Syncope	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0010 affected222 at risk
Varicose vein	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk
Lumbar spinal stenosis	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected223 at risk EG0011 affected222 at risk

ID	Term
D003324	Coronary Artery Disease
D023921	Coronary Stenosis
D003327	Coronary Disease

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019060	Minimally Invasive Surgical Procedures

ID	Title	Description
BG000	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
BG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
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	Elixir Bioadaptor (ELX1805J)	The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions	1	222	60	223	128	223
EG001	Medtronic Resolute Onyx Stent	The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions	3	216	44	222	124	222

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Death - Cardiovascular	Cardiac disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected223 at risk EG0011 affected222 at risk
Death - Non-Cardiovascular	General disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected223 at risk EG0011 affected222 at risk
MI	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	MI	EG0001 affected223 at risk EG0012 affected222 at risk
Revascularization Re-PCI	Cardiac disorders	MedDRA (10.0)	Systematic Assessment		EG00012 affected223 at risk EG00110 affected222 at risk
Revascularization - CABG	Cardiac disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected223 at risk EG0011 affected222 at risk
Stent Thrombosis - Definite	Cardiac disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected223 at risk EG0010 affected222 at risk
Stent Thrombosis - Probable	General disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected223 at risk EG0010 affected222 at risk
Stent Thrombosis - Possible	General disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected223 at risk EG0010 affected222 at risk
CVA - TIA	Nervous system disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected223 at risk EG0010 affected222 at risk
CVA - Ischemic	Nervous system disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected223 at risk EG0010 affected222 at risk
CVA - Haemorrhagic	Nervous system disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected223 at risk EG0010 affected222 at risk
Bleeding	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment		EG0003 affected223 at risk EG0013 affected222 at risk
Other	General disorders	MedDRA (10.0)	Systematic Assessment		EG00041 affected223 at risk EG00125 affected222 at risk
Death - Unknown	General disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected223 at risk EG0011 affected222 at risk