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XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System [EECSS], XIENCE Alpine EECSS, XIENCE PROX EECSS, XIENCE ProA EECSS or XIENCE Sierra EECSS of coronary drug-eluting stents
The XIENCE 28 Global Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 800 to a maximum of 960 subjects will be registered from approximately 50 sites globally and subject registration is capped at 120 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1 month (prior to 1-month visit but at least 28 days) after stenting and have been compliant with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor inhibitor as early as 28 days and continue with aspirin monotherapy through 12-month follow-up.
All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The data collected from the XIENCE 28 Global Study will be compared with the historical control of non-complex HBR subjects treated with standard DAPT up to 12 months from the XIENCE V USA Study .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XIENCE | Experimental | XIENCE + Short duration (1 month) of DAPT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XIENCE | Device | Subjects who received XIENCE family stent systems will be included. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles | Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5) | From 1 to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE) | Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5) | From 6 to 12 months |
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Inclusion Criteria:
Subject is considered at HBR, defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with > 1-month DAPT outweighs the benefit:
Subject must be at least 18 years of age.
Subject must provide written informed consent as approved by the Ethics Committee (EC) of the respective clinical site prior to any trial related procedure.
Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.
Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.
Angiographic Inclusion Criteria
Up to three target lesions with a maximum of two target lesions per epicardial vessel.
Note:
Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
Exclusive use of XIENCE family of stent systems during the index procedure.
Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of <20% with final thrombolysis in myocardial infarction (TIMI-3) flow assessed by online quantitative angiography or visual estimation, with no residual dissection National Heart, Lung, and Blood Institute (NHLBI) grade ≥ type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation > 0.5mm or depression lasting > 5 minutes.
Exclusion Criteria:
Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.
Subject has a known left ventricular ejection fraction (LVEF) <30%.
Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.
Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.
Subject with a current medical condition with a life expectancy of less than 12 months.
Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure.
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.
Note: Female subjects of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release). It is accepted, in certain cases, to include subjects having a sterilised regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the trial design, product characteristics and/or trial population.
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
Angiographic Exclusion Criteria
Note: If there is more than one target lesion, all target lesions must satisfy the angiographic eligibility criteria. Non-target lesion (i.e., lesions that do not meet the angiographic criteria listed above) treatments are not allowed during the index procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Marco Valgimigli, MD | Bern University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler Universitätsklinikum GmbH | Linz | UPR AUS | 4021 | Austria | ||
| Onze-Lieve-Vrouwziekenhuis Campus Aalst |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34794687 | Derived | Valgimigli M, Cao D, Angiolillo DJ, Bangalore S, Bhatt DL, Ge J, Hermiller J, Makkar RR, Neumann FJ, Saito S, Picon H, Toelg R, Maksoud A, Chehab BM, Choi JW, Campo G, De la Torre Hernandez JM, Kunadian V, Sardella G, Thiele H, Varenne O, Vranckx P, Windecker S, Zhou Y, Krucoff MW, Ruster K, Zheng Y, Mehran R; XIENCE 90 and XIENCE 28 Investigators. Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI. J Am Coll Cardiol. 2021 Nov 23;78(21):2060-2072. doi: 10.1016/j.jacc.2021.08.074. | |
| 33031789 |
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A total of 963 subjects were enrolled across 52 sites globally, between 09 February, 2018 and 30 April, 2020. The last subject last visit was on 30 April, 2020 and the final data was extracted from the database on 01 July, 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | XIENCE | XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 13, 2018 | Feb 5, 2021 |
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| DAPT |
| Drug |
1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure. |
|
|
| Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE) | Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5) | From 1 to 12 months |
| Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite) | Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
| From 1 to 6 months |
| Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite) | Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
| From 6 to 12 months |
| Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite) | Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
| From 1 to 12 months |
| Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | From 1 to 6 months |
| Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | From 6 to 12 months |
| Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | From 1 to 12 months |
| Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC) | Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| From 1 to 6 months |
| Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC) | Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| From 6 to 12 months |
| Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC) | Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| From 1 to 12 months |
| Number of Participants With Composite of Cardiac Death or MI (Modified ARC) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| From 1 to 6 months |
| Number of Participants With Composite of Cardiac Death or MI (Modified ARC) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| From 6 to 12 months |
| Number of Participants With Composite of Cardiac Death or MI (Modified ARC) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| From 1 to 12 months |
| Number of Participants With Composite of All Death or All MI (Modified ARC) | All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| From 1 to 6 months |
| Number of Participants With Composite of All Death or All MI (Modified ARC) | All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| From 6 to 12 months |
| Number of Participants With Composite of All Death or All MI (Modified ARC) | All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| From 1 to 12 months |
| Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke | An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.
| From 1 to 6 months |
| Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke | An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.
| From 6 to 12 months |
| Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke | An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.
| From 1 to 12 months |
| Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR) | TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs:
| From 1 to 6 months |
| Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR) | TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs:
| From 6 to 12 months |
| Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR) | TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs:
| From 1 to 12 months |
| Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR) | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:
| From 1 to 6 months |
| Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR) | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:
| From 6 to 12 months |
| Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR) | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:
| From 1 to 12 months |
| Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR) | TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR. | From 1 to 6 months |
| Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR) | TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR. | From 6 to 12 months |
| Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR) | TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR. | From 1 to 12 months |
| Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR) | TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR. | From 1 to 6 months |
| Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR) | TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR. | From 6 to 12 months |
| Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR) | TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR. | From 1 to 12 months |
| Number of Participants With Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 2-5 and Type 3-5 | Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding. | From 1 to 6 months |
| Number of Participants With Bleeding Defined by the BARC, Type 2-5 and Type 3-5 | Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding. | From 6 to 12 months |
| Number of Participants With Bleeding Defined by BARC, Type 2-5 and Type 3-5 | Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding. | From 1 to 12 months |
| Aalst |
| Eflndrs |
| 9300 |
| Belgium |
| UZ Gent | Ghent | Flemish | 42100 | Belgium |
| Ziekenhuis Oost-Limburg | Genk | Limburg | 3600 | Belgium |
| Jesse Ziekenhuis | Hasselt | Limburg | 3500 | Belgium |
| Beijing AnZhen Hospital | Beijing | Beijing Municipality | 100029 | China |
| The Second Hospital of Jilin University | Changchun | N China | China |
| Universitäts-Herzzentrum Freiburg - Bad Krozingen | Bad Krozingen | Bad-wur | 79189 | Germany |
| Elisabeth-Krankenhaus Essen GmbH | Essen | N. RHIN | 45138 | Germany |
| UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz | Mainz | Rhinela | 55131 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | Saxony | 4289 | Germany |
| Segeberger Kliniken GmbH | Bad Segeberg | Schlesw | 23795 | Germany |
| Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF) | Berlin | 12200 | Germany |
| UKE Hamburg (Universitatsklinik Eppendorf) | Hamburg | 20246 | Germany |
| Prince of Wales Hospital | Hong Kong | Hong Ko | Hong Kong |
| Queen Elizabeth Hospital | Hong Kong | Hong Ko | Hong Kong |
| The University of Hong Kong (Queen Mary Hospital) | Hong Kong | HONG KO | Hong Kong |
| Clinica Mediterranea | Naples | Campani | 80122 | Italy |
| AOU Federico II - Università degli Studi di Napoli | Naples | Campani | 80138 | Italy |
| Az.Osp. Universitaria di Ferrara | Cona | Emi-rom | 44124 | Italy |
| AOU di Parma | Parma | Emi-rom | 43126 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Umberto I | Rome | Lazio | 00161 | Italy |
| Policlinico Universitario A. Gemelli | Rome | Lazio | 00168 | Italy |
| Centro Cardiologico Monzino | Milan | Lombard | 20138 | Italy |
| Istituto Clinico Humanitas | Rozzano | Lombard | 20089 | Italy |
| Scheperziekenhuis | Emmen | Drenthe | 7824 AA | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | Friesld | 8934 AD | Netherlands |
| Albert Schweitzer Ziekenhuis | Dordrecht | ZUID | 3318 AT | Netherlands |
| Hospital de Santa Cruz | Carnaxide | Lisbon District | 2799-523 | Portugal |
| Santa Maria Hospital | Lisbon | Lisbon District | 1649-035 | Portugal |
| National Heart Centre Singapore | Singapore | Central | 169609 | Singapore |
| Tan Tock Seng Hospital | Singapore | Central | 308433 | Singapore |
| HCU Virgen de la Victoria | Málaga | Andalu | 29010 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabr | 39008 | Spain |
| Hospital del Mar | Barcelona | Catalon | 08003 | Spain |
| Hospital Clinic I Provincial de Barcelona | Barcelona | Catalon | 08036 | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | Cstleon | 47005 | Spain |
| Hospital Alvaro Cunqueiro Dept of Interventional Cardiology | Vigo | Pontev | 36312 | Spain |
| Hospital Universitario Doce de Octubre | Madrid | 28041 | Spain |
| Kantonsspital Aarau | Aarau | Basel | 5001 | Switzerland |
| Center Inselspital Bern | Bern | 3010 | Switzerland |
| Luzerner Kantonsspital | Lucerne | 6004 | Switzerland |
| Chang Gung Memorial Hospital | Linkou District | Ntaiwan | 333 | Taiwan |
| National Taiwan University Hospital | Taipei | Ntaiwan | 10002 | Taiwan |
| Taipei Veterans General Hospital (VGH) | Taipei | Ntaiwan | 11217 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Staiwan | 83301 | Taiwan |
| Freeman Hospital | Newcastle upon Tyne | NE ENGL | NE7 7DN | United Kingdom |
| Craigavon Area Hospital | Portadown | Nirelnd | BT63 5QQ | United Kingdom |
| Southampton University Hospital | Southampton | Soeast | SO16 6YD | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | Sowest | BH7 7DW | United Kingdom |
| Royal Devon and Exeter Hospital | Exeter | Sowest | EX2 5DW | United Kingdom |
| University Hospital of Wales | Cardiff | Wales | CF14 4XW | United Kingdom |
| Derived |
| Valgimigli M, Cao D, Makkar RR, Bangalore S, Bhatt DL, Angiolillo DJ, Saito S, Ge J, Neumann FJ, Hermiller J, Picon H, Toelg R, Maksoud A, Chehab BM, Wang LJ, Wang J, Mehran R. Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent. Am Heart J. 2021 Jan;231:147-156. doi: 10.1016/j.ahj.2020.09.019. Epub 2020 Oct 6. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | XIENCE | XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Prior Percutaneous Coronary Intervention (PCI) | Number | participants |
| ||||||||||||||||||
| History of Major Bleeding | The number of participants analyzed includes subjects who were available at that time of analysis | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles | Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5) | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 6 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE) | Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5) | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 6 to 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE) | Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5) | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite) | Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up, or withdrew consent, or died before time point analyzed, without any Stent Thrombosis event, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite) | Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up, or withdrew consent, or died before time point analyzed, without any Stent Thrombosis event, are excluded from the denominator. | Posted | Count of Participants | Participants | From 6 to 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite) | Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up, or withdrew consent, or died before time point analyzed, without any Stent Thrombosis event, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 6 to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC) | Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC) | Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 6 to 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC) | Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite of Cardiac Death or MI (Modified ARC) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite of Cardiac Death or MI (Modified ARC) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 6 to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite of Cardiac Death or MI (Modified ARC) | Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite of All Death or All MI (Modified ARC) | All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite of All Death or All MI (Modified ARC) | All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 6 to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite of All Death or All MI (Modified ARC) | All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke | An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke | An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 6 to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke | An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction.
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR) | TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR) | TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 6 to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR) | TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR) | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR) | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 6 to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR) | TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs:
| The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR) | TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR. | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR) | TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR. | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 6 to 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR) | TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR. | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR) | TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR. | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR) | TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR. | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 6 to 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR) | TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR. | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 2-5 and Type 3-5 | Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding. | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Bleeding Defined by the BARC, Type 2-5 and Type 3-5 | Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding. | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 6 to 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Bleeding Defined by BARC, Type 2-5 and Type 3-5 | Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding. | The number of participants analyzed includes subjects who completed follow up at the given time point. Subjects who were lost to follow-up or withdrew consent prior to that time point, without the endpoint of interest, are excluded from the denominator. | Posted | Count of Participants | Participants | From 1 to 12 months |
|
|
1 Year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | XIENCE | XIENCE + Short duration (1 month) of DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT: 1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure. | 55 | 963 | 374 | 963 | 357 | 963 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypochromic Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nephrogenic Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Normochromic Normocytic Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Aortic Valve Incompetence | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Aortic Valve Stenosis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrioventricular Block | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bifascicular Block | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac Tamponade | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Congestive Cardiomyopathy | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dressler's Syndrome | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Mitral Valve Incompetence | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myopericarditis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pleuropericarditis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Right Ventricular Failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Sick Sinus Syndrome | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Sinoatrial Block | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tricuspid Valve Incompetence | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ventricular Extrasystoles | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ventricular Fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vertigo Positional | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Retinal Artery Occlusion | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Colonic Polyp | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Duodenal Ulcer | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Faeces Discoloured | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastritis Erosive | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peritoneal Haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hernia Obstructive | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Impaired Healing | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Multi-Organ Failure | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Jaundice Cholestatic | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Arthritis Infective | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cholecystitis Infective | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Haematoma Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Infectious Pleural Effusion | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Lung Abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Muscle Abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Otitis Externa | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Soft Tissue Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Vulval Abscess | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Compression Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Cranial Nerve Injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Pubis Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Arteriogram Coronary | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood Pressure Abnormal | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Ejection Fraction Decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Electrocardiogram Abnormal | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Joint Effusion | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Musculoskeletal Disorder | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acute Lymphocytic Leukaemia Re | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Biliary Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Bladder Transitional Cell Carc | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Endometrial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Gastrointestinal Tract Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Lung Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Multiple Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Myelofibrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Oesophageal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Pancreatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Pleural Mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Prostate Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Renal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Urethral Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Carotid Artery Stenosis | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cauda Equina Syndrome | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cognitive Disorder | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Complex Regional Pain Syndrome | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hepatic Encephalopathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Loss Of Consciousness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Neurodegenerative Disorder | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Viith Nerve Paralysis | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Mental Disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetic Nephropathy | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Prerenal Failure | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchial Hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Idiopathic Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetic Foot | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Subcutaneous Emphysema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arteriovenous Fistula Operation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac Pacemaker Insertion | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Cataract Operation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Colon Polypectomy | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Hip Arthroplasty | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Limb Immobilisation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Aortic Stenosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arteriovenous Fistula | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Femoral Arterial Stenosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vascular Stenosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypochromic Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Microcytic Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Normochromic Normocytic Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Spontaneous Haematoma | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrial Thrombosis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrioventricular Block First Degree | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bradyarrhythmia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bundle Branch Block Left | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bundle Branch Block Right | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Coronary Artery Dissection | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Visual Impairment | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Aphthous Stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Epigastric Discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastric Disorder | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastritis Erosive | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gingival Bleeding | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hiatus Hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peptic Ulcer | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tooth Loss | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Impaired Healing | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pacemaker Generated Arrhythmia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Spinal Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ulcer | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Biliary Colic | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Liver Disorder | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asymptomatic Bacteriuria | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Enterobiasis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Tinea Cruris | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Vaginal Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac Procedure Complication | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Wound Complication | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Blood Calcium Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood Glucose Abnormal | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Blood Thyroid Stimulating Hormone Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac Enzymes Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Ejection Fraction Decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Glycosylated Haemoglobin Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Prostatic Specific Antigen Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Troponin I Increased | Investigations | MedDRA 11.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Foot Deformity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Muscle Fatigue | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Systemic Sclerosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hepatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Oesophageal Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Balance Disorder | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cervicogenic Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Petit Mal Epilepsy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Restless Legs Syndrome | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tunnel Vision | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Listless | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Sleep Disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cystitis Haemorrhagic | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vaginismus | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Rash Generalised | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac Ablation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
| |
| Aortic Aneurysm | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Femoral Arterial Stenosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Intermittent Claudication | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vascular Dissection | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vascular Stenosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Siok Hwee Tan, PhD, Principal Clinical Research Scientist | Clinical Affairs, Abbott Vascular | +1 408-845-3581 | siokhwee.tan@abbott.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2020 | Feb 5, 2021 | SAP_003.pdf |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D006402 | Hematologic Diseases |
| D013921 | Thrombocytopenia |
| D000740 | Anemia |
| D051437 | Renal Insufficiency |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006425 | Hemic and Lymphatic Diseases |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
Not provided
|
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United Kingdom |
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| Portugal |
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| Belgium |
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| China |
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| Taiwan |
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| Italy |
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| Germany |
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