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The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate 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 and XIENCE Sierra EECSS) of coronary drug-eluting stents.
The XIENCE 28 USA Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 640 to a maximum of 800 subjects will be registered from approximately 50 sites in the United States and Canada. Subject registration is capped at 75 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 continued 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 USA Study will be pooled with the data from the XIENCE 28 Global Study (Protocol # ABT-CIP-10235) to compare with the historical control of non-complex HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XIENCE | Experimental | XIENCE + 1 month 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 |
|---|---|---|
| Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile | 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 Definition (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 |
| Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile | 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 Definition (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 |
| Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile | 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 Definition (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles | Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:
|
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Inclusion Criteria:
Subject is considered at high risk for bleeding (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 Institutional Review Board (IRB) 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, except for cases where subject is transferred to the XIENCE 90 study after the 1-month visit assessment
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 TIMI-3 flow assessed by online quantitative angiography or visual estimation, with no residual dissection 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:
Angiographic Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Roxana Mehran, MD | Mount Sinai Medical Center,New York, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC | Huntsville | Alabama | 35801 | United States | ||
| Phoenix Cardiovascular Research Group |
| 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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The data collected from the XIENCE 28 USA Study was pooled with the data from the XIENCE 28 Global Study (NCT # NCT03355742) to compare with the historical control of non-complex HBR subjects treated with standard DAPT duration of up to 12 months from the XIENCE V USA Study.
A total of 1605 subjects were enrolled in XIENCE 28 study. The XIENCE 28 USA study was conducted at 58 sites in the US and Canada between February 25, 2019 and February 7, 2020. While XIENCE 28 Global study was conducted at 52 sites in Europe and Asia between February 9, 2018 and April 22, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | XIENCE | XIENCE + 1 month dual antiplatelet therapy (DAPT) XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up. |
| 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 | Dec 4, 2018 | Aug 30, 2021 |
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| DAPT (aspirin and/or P2Y12 receptor inhibitor) |
| Drug |
"1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up. |
|
|
| From 1 to 12 months |
| From 1 to 6 months |
| Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles | Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:
| From 6 to 12 months |
| Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles | Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:
| 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 All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death) | All Death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients 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 All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death) | All Death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients 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 All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death) | All Death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients 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) | All Myocardial Infarction (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. | From 1 to 6 months |
| Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC) | All Myocardial Infarction (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. | From 6 to 12 months |
| Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC) | All Myocardial Infarction (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. | 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) | Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion 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 clinically indicated by the investigator prior to repeat angiography. Clinically Indicated [CI] Revascularization: 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 CI-TLR | Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion 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 clinically indicated by the investigator prior to repeat angiography. Clinically Indicated [CI] Revascularization: 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 CI-TLR | Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion 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 clinically indicated by the investigator prior to repeat angiography. Clinically Indicated [CI] Revascularization: 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 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 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 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, 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, 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, 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 Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5 | Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:
| From 1 to 6 months |
| Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5 | Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:
| From 6 to 12 months |
| Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5 | Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:
| From 1 to 12 months |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Scottsdale Healthcare Shea | Scottsdale | Arizona | 85260 | United States |
| NEA Baptist Clinic | Jonesboro | Arkansas | 72401 | United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Mission Cardiovascular Research Institute | Fremont | California | 94538 | United States |
| Scripps Memorial Hospital - La Jolla | La Jolla | California | 92037 | United States |
| Huntington Memorial Hospital | Pasadena | California | 91109 | United States |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93105 | United States |
| Kaiser Permanente - Santa Clara | Santa Clara | California | 95051 | United States |
| Cardiology Associates of Fairfield County, PC | Norwalk | Connecticut | 06851 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Clearwater Cardiovascular Consultants | Clearwater | Florida | 33756 | United States |
| Morton Plant Hospital | Clearwater | Florida | 33756 | United States |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Redmond Regional Medical Center | Rome | Georgia | 30165 | United States |
| Via Christi Regional Medical Center - St. Francis Campus | Wichita | Kansas | 67214-3882 | United States |
| Cardiovascular Research Institute of Kansas | Wichita | Kansas | 67226 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Union Memorial Hospital | Baltimore | Maryland | 21218 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Isreal Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| McLaren Health Care Corporation | Auburn Hills | Michigan | 48326 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| Missouri Heart Center | Columbia | Missouri | 65201 | United States |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States |
| Mount Sinai Hospital | New York | New York | 10019 | United States |
| Lenox Hill Hospital | New York | New York | 10021 | United States |
| St. Joseph's Hospital Health Center | Syracuse | New York | 13203 | United States |
| Novant Health Heart and Vascular Research Institute | Charlotte | North Carolina | 28204 | United States |
| Cone Health Medical Group Heartcare | Greensboro | North Carolina | 27401 | United States |
| NC Heart & Vascular Research | Raleigh | North Carolina | 27607 | United States |
| Wake Forest University Medical Center Clinical Sciences | Winston-Salem | North Carolina | 27157- 1045 | United States |
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| UPMC Hamot | Erie | Pennsylvania | 16550 | United States |
| Pinnacle Health System | Harrisburg | Pennsylvania | 17105 | United States |
| Presbyterian Medical Center (PA) | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| St. Joseph Medical Center | Reading | Pennsylvania | 19605 | United States |
| Anmed Health | Anderson | South Carolina | 29621 | United States |
| Sanford USD Medical Center | Sioux Falls | South Dakota | 57117 | United States |
| East Tennessee Heart Consultants | Knoxville | Tennessee | 37920 | United States |
| Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| Baylor Scott and White Heart and Vascular Hospital | Dallas | Texas | 75226 | United States |
| Mission Research Institute | New Braunfels | Texas | 78130 | United States |
| HeartPlace Methodist Richardson | Richardson | Texas | 75082 | United States |
| East Texas Medical Center | Tyler | Texas | 75701 | United States |
| Mary Washington Hospital | Fredericksburg | Virginia | 22401 | United States |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | United States |
| Kepler Universitätsklinikum GmbH | Linz | UPR AUS | 4021 | Austria |
| Onze-Lieve-Vrouwziekenhuis Campus Aalst | Aalst | Eflndrs | 9300 | Belgium |
| UZ Gent | Ghent | Flemish | 42100 | Belgium |
| Ziekenhuis Oost-Limburg | Genk | Limburg | 3600 | Belgium |
| Jesse Ziekenhuis Campus Virga Jesse | Limbourg | 3500 | Belgium |
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada |
| Royal Jubilee Hospital | Victoria | British Columbia | V8R 1J8 | Canada |
| Saint John Regional Hospital - New Brunswick Heart Centre | Saint John | New Brunswick | E2L4L2 | Canada |
| Institute de Cardiologie de Montreal (Montreal Heart Inst.) | Montreal | Quebec | H1T1C8 | Canada |
| Hopital du Sacre-Coeur de | Montreal | Quebec | H4J1C5 | Canada |
| Beijing AnZhen Hospital | Beijing | Beijing Municipality | 100029 | China |
| The Second Hospital of Jilin University | Changchun | N China | 130041 | 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 MainzLangenbeckstrasse | Mainz | Rhinela | 55131 | Germany |
| Herzzentrum Leipzig GmbH04289 | Leipzig | Saxony | 04289 | Germany |
| Segeberger Kliniken GmbH Am Kurpark 1 | Bad Segeberg | Schlesw | 23795 | Germany |
| Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF) | Berlin | 12200 | Germany |
| UKE Hamburg (Universitatsklinik Eppendorf) | Hamburg | 20246 | Germany |
| The University of Hong Kong (Queen Mary Hospital) | Hong Kong | 1928 | Hong Kong |
| Prince of Wales Hospital | Hong Kong | Hong Kong |
| Queen Elizabeth Hospital | Hong Kong | 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 Boermarkeweg | Emmen | Drenthe | 7824 | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | Friesld | 8934 | Netherlands |
| Albert Schweitzer Ziekenhuis Albert Schweitzerplaats | Dordrecht | Zuid | 3318 | Netherlands |
| Hospital de Santa Cruz | Carnaxide | Lisbon District | 2799-523 | Portugal |
| Santa Maria Hospital | Lisbon | Lisbon District | 1649-035 | Portugal |
| National Heart Centre | Singapore | Central Singapore | 169609 | Singapore |
| Tan Tock Seng Hospital | Singapore | Singapore Central | 308433 | Singapore |
| HCU Virgen de la Victoria Campus Universitario de Teatinos | Málaga | Andalu | 29010 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabr | 39008 | Spain |
| Hospital del Mar Passeig Maritim de la Barceloneta | 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 | 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 | STailwan | 83301 | Taiwan |
| Freeman Hospital | High Heaton | Newcastle Upon Tyne | 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 & 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 |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | XIENCE | XIENCE + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up. |
| 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 |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Prior Percutaneous Coronary Intervention (PCI) | Count of Participants | 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 | Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (MI) (Modified Academic Research Consortium [ARC]), by Propensity Score Quintile | 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 Definition (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 were available at that time of analysis | Posted | Number | percentage of participants | From 1 to 6 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile | 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 Definition (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 were available at that time of analysis | Posted | Number | percentage of participants | From 6 to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Composite Rate of All Death or All Myocardial Infarction (Modified ARC), by Propensity Score Quintile | 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 Definition (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 were available at that time of analysis | Posted | Number | percentage of participants | From 1 to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Major Bleeding Rate (Bleeding Academic Research Consortium [BARC] Type 2-5), by Propensity Score Quintiles | Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:
| The number of participants analyzed for each time frame and outcome measure will vary based on:
| Posted | Number | percentage of participants | From 1 to 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles | Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:
| The number of participants analyzed for each time frame and outcome measure will vary based on:
| Posted | Number | percentage of participants | From 6 to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Major Bleeding Rate (BARC Type 2-5), by Propensity Score Quintiles | Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions:
| The number of participants analyzed for each time frame and outcome measure will vary based on:
| Posted | Number | percentage of 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 for each time frame and outcome measure will vary based on:
| 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 for each time frame and outcome measure will vary based on:
| 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 for each time frame and outcome measure will vary based on:
| Posted | Count of Participants | Participants | From 1 to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death) | All Death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients 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 were available at that time of analysis | Posted | Count of Participants | Participants | From 1 to 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death) | All Death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients 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 were available at that time of analysis | Posted | Count of Participants | Participants | From 6 to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of All Death (Cardiac Death, Vascular Death, Non-cardiovascular Death) | All Death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even inpatients 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 were available at that time of analysis | 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) | All Myocardial Infarction (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. | The number of participants analyzed for each time frame and outcome measure will vary based on:
| Posted | Count of Participants | Participants | From 1 to 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC) | All Myocardial Infarction (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. | The number of participants analyzed for each time frame and outcome measure will vary based on:
| Posted | Count of Participants | Participants | From 6 to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All MI and MI Attributed to Target Vessel (TV-MI, Modified ARC) | All Myocardial Infarction (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia:
AND confirmed with elevated cardiac biomarkers per ARC criteria:
TV-MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. | The number of participants analyzed for each time frame and outcome measure will vary based on:
| 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 were available at that time of analysis | 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 were available at that time of analysis | 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 were available at that time of analysis | 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 were available at that time of analysis | 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 were available at that time of analysis | 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 were available at that time of analysis | 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 for each time frame and outcome measure will vary based on:
| 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 for each time frame and outcome measure will vary based on:
| 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 for each time frame and outcome measure will vary based on:
| Posted | Count of Participants | Participants | From 1 to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR) | Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion 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 clinically indicated by the investigator prior to repeat angiography. Clinically Indicated [CI] Revascularization: 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 were available at that time of analysis | Posted | Count of Participants | Participants | From 1 to 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With CI-TLR | Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion 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 clinically indicated by the investigator prior to repeat angiography. Clinically Indicated [CI] Revascularization: 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 were available at that time of analysis | Posted | Count of Participants | Participants | From 6 to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With CI-TLR | Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion 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 clinically indicated by the investigator prior to repeat angiography. Clinically Indicated [CI] Revascularization: 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 were available at that time of analysis | 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 were available at that time of analysis | Posted | Count of Participants | Participants | From 1 to 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With 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 were available at that time of analysis | Posted | Count of Participants | Participants | From 6 to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With 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 were available at that time of analysis | 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 were available at that time of analysis | 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 were available at that time of analysis | 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 were available at that time of analysis | Posted | Count of Participants | Participants | From 1 to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF, 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 were available at that time of analysis | Posted | Count of Participants | Participants | From 1 to 6 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF, 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 were available at that time of analysis | Posted | Count of Participants | Participants | From 6 to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Failure (TVF, 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 were available at that time of analysis | Posted | Count of Participants | Participants | From 1 to 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5 | Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:
| The number of participants analyzed for each time frame and outcome measure will vary based on:
| Posted | Count of Participants | Participants | From 1 to 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5 | Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:
| The number of participants analyzed for each time frame and outcome measure will vary based on:
| Posted | Count of Participants | Participants | From 6 to 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 3-5 | Bleeding per Bleeding Academic Research Consortium (BARC) adjudicated definitions are as follows:
| The number of participants analyzed for each time frame and outcome measure will vary based on:
| 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 + 1 month DAPT XIENCE: Subjects who received XIENCE family stent systems will be included. DAPT (aspirin and/or P2Y12 receptor inhibitor): "1-month clear" subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up. | 86 | 1,605 | 615 | 1,605 | 296 | 1,605 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| Hypochromic Anaemia | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| Nephrogenic Anaemia | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| Normochromic Normocytic Anaemia | Blood and lymphatic system disorders | MedDRA 15 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Aortic Valve Incompetence | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Aortic Valve Stenosis | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Atrial Tachycardia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Atrioventricular Block | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Bifascicular Block | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Cardiac Failure Chronic | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Cardiac Tamponade | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Cardiogenic Shock | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Congestive Cardiomyopathy | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Coronary Artery Stenosis | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Diastolic Dysfunction | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Dressler's Syndrome | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Ischaemic Cardiomyopathy | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Mitral Valve Incompetence | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Myopericarditis | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Pleuropericarditis | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Pulseless Electrical Activity | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Right Ventricular Failure | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Sick Sinus Syndrome | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Sinoatrial Block | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Tricuspid Valve Incompetence | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Ventricular Extrasystoles | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Ventricular Fibrillation | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 15 | Systematic Assessment |
| |
| Vertigo Positional | Ear and labyrinth disorders | MedDRA 15 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 15 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 15 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 15 | Systematic Assessment |
| |
| Retinal Artery Occlusion | Eye disorders | MedDRA 15 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Colonic Polyp | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Duodenal Ulcer | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Faeces Discoloured | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Gastritis Erosive | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Oesophageal Stenosis | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Pancreatitis Necrotising | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Rectal Ulcer | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Varices Oesophageal | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Catheter Site Haemorrhage | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Dysplasia | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15 | Systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Hernia Obstructive | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Impaired Healing | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Multi-Organ Failure | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
| |
| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
| |
| Jaundice Cholestatic | Hepatobiliary disorders | MedDRA 15 | Systematic Assessment |
| |
| Abdominal Infection | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Arthritis Infective | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Cholecystitis Infective | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Corona Virus Infection | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Gallbladder Abscess | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Haematoma Infection | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Infectious Pleural Effusion | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Lung Abscess | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Muscle Abscess | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Otitis Externa | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Pharyngitis Streptococcal | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Sepsis Syndrome | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Severe Acute Respiratory Syndrome | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Soft Tissue Infection | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Vulval Abscess | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Compression Fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Cranial Nerve Injury | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Forearm Fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Perirenal Haematoma | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Pubis Fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Toxicity To Various Agents | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Vascular Graft Complication | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Arteriogram Coronary | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Blood Pressure Abnormal | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Blood Urine Present | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Cardiac Stress Test Abnormal | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Ejection Fraction Decreased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Electrocardiogram Abnormal | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Heart Rate Decreased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Troponin Increased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Joint Effusion | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Musculoskeletal Disorder | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Acute Lymphocytic Leukaemia Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Biliary Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Bladder Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Colon Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Endometrial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Gastrointestinal Tract Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Lung Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Metastases To Central Nervous | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Multiple Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Myelofibrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Neuroendocrine Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Non-Small Cell Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Oesophageal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Pancreatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Pleural Mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Prostate Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Renal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Small Cell Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Squamous Cell Carcinoma Of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Urethral Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Carotid Artery Disease | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Carotid Artery Stenosis | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Cauda Equina Syndrome | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Cognitive Disorder | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Complex Regional Pain Syndrome | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Hepatic Encephalopathy | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Loss Of Consciousness | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Lumbar Radiculopathy | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Metabolic Encephalopathy | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Neurodegenerative Disorder | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Viith Nerve Paralysis | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
| |
| Mental Disorder | Psychiatric disorders | MedDRA 15 | Systematic Assessment |
| |
| Diabetic Nephropathy | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
| |
| Prerenal Failure | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA 15 | Systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA 15 | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 15 | Systematic Assessment |
| |
| Scrotal Mass | Reproductive system and breast disorders | MedDRA 15 | Systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Bronchial Hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Idiopathic Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Pulmonary Mass | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Diabetic Foot | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
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| Subcutaneous Emphysema | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
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| Telangiectasia | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
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| Arteriovenous Fistula Operation | Surgical and medical procedures | MedDRA 15 | Systematic Assessment |
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| Cardiac Pacemaker Insertion | Surgical and medical procedures | MedDRA 15 | Systematic Assessment |
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| Cataract Operation | Surgical and medical procedures | MedDRA 15 | Systematic Assessment |
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| Colon Polypectomy | Surgical and medical procedures | MedDRA 15 | Systematic Assessment |
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| Hip Arthroplasty | Surgical and medical procedures | MedDRA 15 | Systematic Assessment |
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| Hospitalisation | Surgical and medical procedures | MedDRA 15 | Systematic Assessment |
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| Limb Immobilisation | Surgical and medical procedures | MedDRA 15 | Systematic Assessment |
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| Mitral Valve Repair | Surgical and medical procedures | MedDRA 15 | Systematic Assessment |
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| Osteomyelitis Drainage | Surgical and medical procedures | MedDRA 15 | Systematic Assessment |
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| Aortic Stenosis | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Arteriovenous Fistula | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Femoral Arterial Stenosis | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Hypertensive Crisis | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Hypertensive Emergency | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Intermittent Claudication | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Orthostatic Hypotension | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Peripheral Ischaemia | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Peripheral Vascular Disorder | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Vascular Stenosis | Vascular disorders | MedDRA 15 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA 15 | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA 15 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lijuan Jenn Wang | Abbott | 01-408-8453133 | Lijuan.wang1@abbott.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2020 | Aug 30, 2021 | SAP_001.pdf |
Not provided
| 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
| ID | Term |
|---|---|
| C028145 | 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine |
Not provided
Not provided
Not provided
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