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XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are
Study Phase I is from index procedure to 1 year. This prospective, open-label, multi-center, observational, single-arm study is designed to evaluate XIENCE V EECSS safety and effectiveness in real world settings up to 1 year after implantation. The primary endpoint is the stent thrombosis (definite and probable) rate up to 1 year as ARC. The co-primary endpoint is the composite rate of cardiac death and any MI at 1 year. Up to 8,000 patients are planned to be consecutively enrolled at up to 275 sites in the U.S. Clinical follow-up will occur at 14, 30, 180 days and 1 year.
All patients enrolled in the XIENCE V USA who have completed Study Phase I will be evaluated at 1 year to determine whether they are eligible to participate in one of the following cohorts in Study Phase II: XIENCE V USA Long Term Follow-up (LTF) Cohort, Harvard Clinical Research Institute (HCRI) DAPT Cohort, or Abbott Vascular (AV) DAPT Cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Single-arm study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XIENCE V® Everolimus Eluting Coronary Stent | Device | Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings. |
| Measure | Description | Time Frame |
|---|---|---|
| Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium). | ARC Defines Stent Thrombosis in the following way: Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria: Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause Possible Stent Thrombosis Any unexplained death beyond 30 days For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1 | up to 1 year |
| Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) | MI= ARC (Academic Research Constortium) defined | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Device Success | acute: post index procedure until hospital discharge | |
| Procedural Success | acute: post index procedure until hospital discharge | |
| Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave) |
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Inclusion Criteria:
Exclusion Criteria:
Age limit is determined by investigator.
There are no angiographic inclusion or exclusion criteria for this study.
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Patients who agree to participate by signing the Institutional Review Board (IRB) approved informed consent form, and who recieve only XIENCE V® EECSS during the index procedure.
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| Name | Affiliation | Role |
|---|---|---|
| James Hermiller, MD | Heart Center of Indianapolis | Principal Investigator |
| Mitch Krucoff, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Vascular | Santa Clara | California | 95054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25940520 | Derived | Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362. | |
| 23172848 |
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A sub-set of subjects was randomized to the DAPT portion of this study.
Subjects are derived from the USA interventional cardiology population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Receiving the XIENCE V EECSS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Receiving the XIENCE V EECSS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium). | ARC Defines Stent Thrombosis in the following way: Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria: Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause Possible Stent Thrombosis Any unexplained death beyond 30 days For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1 | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 1 year |
1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Receiving the XIENCE V EECSS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Travis | Abbott Vascular | 408-845-3000 | Ellen.Travis@av.abbott.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023903 | Coronary Restenosis |
| D023921 | Coronary Stenosis |
| D014652 | Vascular Diseases |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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MI= Academic Research Consortium (ARC) defined |
| at 30 days |
| Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 180 days |
| Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 30 days |
| Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 180 days |
| Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 1 year |
| Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) | MI= Academic Research Consortium (ARC) defined | at 30 days |
| Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) | MI= Academic Research Consortium (ARC) defined | at 180 days |
| Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) | MI= Academic Research Consortium (ARC) defined | at 1 year |
| Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG) | MI= Academic Research Consortium (ARC) defined | at 30 days |
| Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG) | MI= Academic Research Consortium (ARC) defined | at 180 days |
| Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG) | MI= Academic Research Consortium (ARC) defined | at 1 year |
| Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) | at 30 days |
| Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) | at 180 days |
| Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) | at 1 year |
| Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 30 days |
| Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 180 days |
| Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | at 1 year |
| Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) | at 30 days |
| Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) | at 180 days |
| Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) | at 1 year |
| Major Bleeding Complications | by TIMI flow | at 14 days |
| Major Bleeding Complications | by TIMI flow | at 30 days |
| Major Bleeding Complications | by TIMI flow | at 180 days |
| Major Bleeding Complications | by TIMI flow | at 1 year |
| Dual Antiplatelet Medication Usage | Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications. | at 14 days |
| Dual Antiplatelet Medication Usage | Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications. | at 30 days |
| Dual Antiplatelet Medication Usage | Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications. | at 180 days |
| Dual Antiplatelet Medication Usage | Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications. | at 1 year |
| Dual Antiplatelet Therapy Non-compliance Through 1 Year | Defined as patients who had at least 1 day without using either aspirin or thienopyridine from 1 to 407 days post index procedure. | 1 year |
| Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF) | MI= Academic Research Consortium (ARC) defined | at 30 days |
| Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF) | MI= Academic Research Consortium (ARC) defined | at 180 days |
| Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF) | MI= Academic Research Consortium (ARC) defined | at 1 year |
| Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire) | SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | at baseline |
| Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire) | SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | at 180 days |
| Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire) | SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | at 1 year |
| SAQ (Seattle Angina Questionaire) | SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | at baseline |
| SAQ (Seattle Angina Questionaire) | SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | 180 days |
| SAQ (Seattle Angina Questionaire) | SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | 1 year |
| Derived |
| Sudhir K, Hermiller JB, Naidu SS, Henry TD, Mao VW, Zhao W, Ferguson JM, Wang J, Jonnavithula L, Simonton CA, Rutledge DR, Krucoff MW; XIENCE V USA Investigators. Clinical outcomes in real-world patients with acute myocardial infarction receiving XIENCE V(R) everolimus-eluting stents: one-year results from the XIENCE V USA study. Catheter Cardiovasc Interv. 2013 Oct 1;82(4):E385-94. doi: 10.1002/ccd.24749. Epub 2013 Mar 28. |
| 22998355 | Derived | Hermiller JB, Rutledge DR, Gruberg L, Katopodis JN, Lombardi W, Mao VW, Zhao W, Sharma SK, Tamboli HP, Wang J, Jonnavithula L, Sudhir K, Krucoff MW. Sustained low clinical event rates in real-world patients receiving everolimus-eluting coronary stent system from a large, prospective, condition of approval study: 2-year clinical outcomes from the XIENCE V USA Study. J Interv Cardiol. 2012 Dec;25(6):565-75. doi: 10.1111/j.1540-8183.2012.00766.x. Epub 2012 Sep 23. |
| 22721657 | Derived | Naidu SS, Krucoff MW, Rutledge DR, Mao VW, Zhao W, Zheng Q, Wilburn O, Sudhir K, Simonton C, Hermiller JB. Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation: results from the 8,061-patient XIENCE V United States study. JACC Cardiovasc Interv. 2012 Jun;5(6):626-35. doi: 10.1016/j.jcin.2012.02.014. |
| 22192371 | Derived | Krucoff MW, Rutledge DR, Gruberg L, Jonnavithula L, Katopodis JN, Lombardi W, Mao VW, Sharma SK, Simonton CA, Tamboli HP, Wang J, Wilburn O, Zhao W, Sudhir K, Hermiller JB. A new era of prospective real-world safety evaluation primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-of-approval post-market study). JACC Cardiovasc Interv. 2011 Dec;4(12):1298-309. doi: 10.1016/j.jcin.2011.08.010. |
| Physician Decision |
|
| Ineligible for Randomization to DAPT |
|
| Other Reason |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Subjects Receiving the XIENCE V EECSS |
|
|
| Primary | Composite Rate of Cardiac Death and Any Myocardial Infarction (MI) | MI= ARC (Academic Research Constortium) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
| Secondary | Clinical Device Success | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. | Posted | Number | 95% Confidence Interval | percentage of lesions | acute: post index procedure until hospital discharge | Lesions | Participants |
|
|
|
| Secondary | Procedural Success | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. | Posted | Number | 95% Confidence Interval | percentage of participants | acute: post index procedure until hospital discharge |
|
|
|
| Secondary | Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 30 days |
|
|
|
| Secondary | Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 180 days |
|
|
|
| Secondary | Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 30 days |
|
|
|
| Secondary | Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 180 days |
|
|
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| Secondary | Composite Rate of All Death and Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 1 year |
|
|
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| Secondary | Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 30 days |
|
|
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| Secondary | Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 180 days |
|
|
|
| Secondary | Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG]) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 1 year |
|
|
|
| Secondary | Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 30 days |
|
|
|
| Secondary | Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 180 days |
|
|
|
| Secondary | Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 1 year |
|
|
|
| Secondary | Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 30 days |
|
|
|
| Secondary | Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 180 days |
|
|
|
| Secondary | Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death) | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 1 year |
|
|
|
| Secondary | Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 30 days |
|
|
|
| Secondary | Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 180 days |
|
|
|
| Secondary | Any MI (Q-wave and Non Q-wave) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 1 year |
|
|
|
| Secondary | Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 30 days |
|
|
|
| Secondary | Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 180 days |
|
|
|
| Secondary | Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG) | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 1 year |
|
|
|
| Secondary | Major Bleeding Complications | by TIMI flow | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 14 days |
|
|
|
| Secondary | Major Bleeding Complications | by TIMI flow | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 30 days |
|
|
|
| Secondary | Major Bleeding Complications | by TIMI flow | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 180 days |
|
|
|
| Secondary | Major Bleeding Complications | by TIMI flow | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 1 year |
|
|
|
| Secondary | Dual Antiplatelet Medication Usage | Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications. | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. | Posted | Number | percentage of participants | at 14 days |
|
|
|
| Secondary | Dual Antiplatelet Medication Usage | Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications. | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. | Posted | Number | percentage of participants | at 30 days |
|
|
|
| Secondary | Dual Antiplatelet Medication Usage | Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications. | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. | Posted | Number | percentage of participants | at 180 days |
|
|
|
| Secondary | Dual Antiplatelet Medication Usage | Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin & Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications. | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. | Posted | Number | percentage of participants | at 1 year |
|
|
|
| Secondary | Dual Antiplatelet Therapy Non-compliance Through 1 Year | Defined as patients who had at least 1 day without using either aspirin or thienopyridine from 1 to 407 days post index procedure. | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. | Posted | Number | percentage of participants | 1 year |
|
|
|
| Secondary | Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 30 days |
|
|
|
| Secondary | Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 180 days |
|
|
|
| Secondary | Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF) | MI= Academic Research Consortium (ARC) defined | Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Number | 95% Confidence Interval | percentage of participants | at 1 year |
|
|
|
| Secondary | Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire) | SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Mean | Standard Deviation | units on the SAQ scale | at baseline |
|
|
|
| Secondary | Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire) | SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Mean | Standard Deviation | units on the SAQ scale | at 180 days |
|
|
|
| Secondary | Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire) | SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Mean | Standard Deviation | units on the SAQ scale | at 1 year |
|
|
|
| Secondary | SAQ (Seattle Angina Questionaire) | SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Mean | Standard Deviation | units on the SAQ scale | at baseline |
|
|
|
| Secondary | SAQ (Seattle Angina Questionaire) | SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Mean | Standard Deviation | units on the SAQ scale | 180 days |
|
|
|
| Secondary | SAQ (Seattle Angina Questionaire) | SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. | First enrollment phase of ~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician. | Posted | Mean | Standard Deviation | units on the SAQ scale | 1 year |
|
|
|
| 1,656 |
| 4,952 |
| 478 |
| 4,952 |
| Acute myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute pulmonary edema | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic valve disease | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arteriospasm coronary | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrial thrombosis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery dissection | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery perforation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery thrombosis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Electromechanical dissociation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Low cardiac output syndrome | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Mitral valve calcification | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Mitral valve stenosis | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pericardial haemorrhage | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Post procedural myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sinus arrest | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sinus arrhythmia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sudden cardiac death | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ventricular dysfunction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Drug withdrawal syndrome | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Exercise tolerance decreased | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Generalised edema | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Infusion site phlebitis | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Edema | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Contrast media reaction | Immune system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery reocclusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Device dislocation | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Implantable defibrillator malfunction | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| In-stent arterial restenosis | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| In-stent coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Lead dislodgement | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Mechanical complication of implant | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Other injuries | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment | Other injuries consists of all the PTs which were not in Administration site reactions and Procedural and device related injuries HLGT category for the corresponding SOC. |
|
| Pacemaker complication | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Post procedural haemorrhagen | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Reperfusion injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Stent-graft endoleak | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Thrombosis in device | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Vessel perforation | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Weaning failure | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Anoxic encephalopathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Carotid sinus syndrome | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Complex partial seizures | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Embolic cerebral infarction | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Facial palsy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Facial paresis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypertensive encephalopathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypoglycaemic encephalopathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Moyamoya disease | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Muscular weakness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neurological symptom | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neuromyelitis optica | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Spondylitic myelopathy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Unresponsive to stimulie | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ear and labyrinth disorders | Ear and labyrinth disorders | MedDRA (11.0) | Systematic Assessment |
|
| Endocrine disorders | Endocrine disorders | MedDRA (11.0) | Systematic Assessment |
|
| Eye disorders | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Investigations | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
|
| Other renal and urinary disorders | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment | Other renal and urinary disorders consist of all the PTs which were not in Acute renal failure for the corresponding SOC. |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspnoea paroxysmal nocturnal | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pickwickian syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Accelerated hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic aneurysms | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arterial thrombosis limb | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arteriovenous malformation | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Carotid artery disease | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Carotid artery occlusion | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Carotid artery stenosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Epistaxis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Femoral arterial stenosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Femoral artery occlusion | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haemoptysis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Iliac artery occlusion | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Labile blood pressure | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Muscle haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pulmonary hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rectal haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Renal artery occlusion | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Renal artery stenosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Retroperitoneal haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Subclavian artery stenosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vascular insufficiency | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vascular pseudoaneurysm | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Aortic intramural haematoma | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Investigations | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
Not provided
| D001157 |
| Arterial Occlusive Diseases |