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This multicenter, single-arm retrospective registry (chart review) is being conducted to confirm the clinical performance and safety of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft throughout the device functional lifetime for each indication area.
Up to 9 sites in Europe will be required to enroll 353 patients that have had treatment with GORE-TEX® Vascular Grafts or GORE® PROPATEN® Vascular Grafts in the following indication areas:
144 patients in PAD Cohort
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAD Cohort | Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft |
| |
| AAA Cohort | Patient underwent simultaneous or staged aortic aneurysm repair (open surgical AAA or TAAA) involving a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft |
| |
| Dialysis Access Cohort | Patient required the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease using a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® PROPATEN® Vascular Graft | Device | Patients that have had treatment with GORE® PROPATEN® Vascular Graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| PAD Cohort: Primary Safety Outcome: Device-related Seroma or Infection | Clinical evidence of an infectious process in the direct vicinity of the access site or distal to the treated vascular site or seroma classified by the registry investigator as primarily related to the registry device. | Data were collected retrospectively from health registries, for up to 5 years after index procedure date |
| PAD Cohort: Primary Performance Outcome: Secondary Patency (Revascularization) | Patency of the study graft with additional or secondary surgical or endovascular procedures to restore flow to the graft after occlusion or stenosis of the graft or its anastomoses. The only exceptions that do not disqualify the graft for secondary patency are procedures performed for disease beyond the graft and its two anastomoses. | Data were collected retrospectively from health registries, for up to 5 years after index procedure date |
| Aortic Aneurysm Cohort: Primary Safety Outcome: Survival Through 5 Years | All Cause survival | Data were collected retrospectively from health registries, for up to 5 years after index procedure date |
| Aortic Aneurysm Cohort: Primary Performance Outcome: Primary Patency Through 5 Years | Patency of the study graft without additional or secondary surgical or endovascular procedures to maintain or restore flow to the graft. The only exceptions that do not disqualify the graft for primary patency are procedures performed for disease beyond the graft and its two anastomoses. | Data were collected retrospectively from health registries, for up to 5 years after index procedure date |
| Dialysis Access Cohort: Primary Safety Outcome: Device-related Infection Through 2 Years | Clinical evidence of an infectious process in the direct vicinity of the access site classified by the study investigator as primarily related to the study device. |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Artery Disease Cohort: Limb Salvage Through 1 Year | Freedom from an amputation above the level of the ankle of the index limb | Data were collected retrospectively from health registries, for up to 1 year after index procedure date |
| Peripheral Artery Disease Cohort: Amputation-free Survival Through 1 Year |
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Inclusion Criteria:
General Inclusion Criteria
PAD Cohort Inclusion Criteria 1. Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft at least 5 years before site initiation.
Aortic Aneurysm Cohort Inclusion Criteria
1. Patient underwent simultaneous or staged aortic aneurysm repair (open surgical AAA or TAAA) involving a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft at least 5 years before site initiation. Research device could have been used to replace or bypass either a diseased visceral branch or the aorta itself.
Dialysis Access Cohort Inclusion Criteria 1. Patient required the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease using a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft at least 2 years before site initiation with the intent to cannulate the registry device.
Exclusion Criteria:
General Exclusion Criteria
PAD Cohort Exclusion Criteria
At the time of treatment, the patient must not have met any of the following criteria:
Aortic Aneurysm Cohort Exclusion Criteria
At the time of treatment, the patient must not have met any of the following criteria:
1. Patient required emergency surgery due to aneurysm rupture.
Dialysis Access Cohort Exclusion Criteria
At the time of treatment, the patient must not have met any of the following criteria:
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The study population will consist of three cohorts. Patients that have had treatment with GORE-TEX® Vascular Grafts or GORE® PROPATEN® Vascular Graft for PAD, aortic aneurysms, or dialysis access are eligible for consideration for enrollment in the registry.
Patients will be selected from hospital database.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Unversitaire d'Angers | Angers | France | ||||
| CHRU de Besançon |
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| ID | Title | Description |
|---|---|---|
| FG000 | PAD Cohort | Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts |
| 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 | Jun 16, 2021 | Mar 12, 2025 |
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| GORE-TEX® Vascular Grafts | Device | Patients that have had treatment with GORE-TEX® Vascular Grafts |
|
| Data were collected retrospectively from health registries, for up to 2 years after index procedure date |
| Dialysis Access Cohort: Useable Access Circuit (Reported as Secondary Patency) Through 2 Years | Patency of the study graft from the time of access creation or placement until access abandonment. | Data were collected retrospectively from health registries, for up to 2 years after index procedure date |
Freedom from an amputation above the level of the ankle of the index limb or all cause death |
| Data were collected retrospectively from health registries, for up to 1 year after index procedure date |
| Peripheral Artery Disease Cohort: Device-related Adverse Events Through 1 Year | Any untoward medical occurrence classified by the registry investigator as primarily related to the registry device | Data were collected retrospectively from health registries, for up to 1 year after index procedure date |
| Peripheral Artery Disease Cohort: Primary Patency Through 1 Year | Patency of the study graft without additional or secondary surgical or endovascular procedures to maintain or restore flow to the graft. The only exceptions that do not disqualify the graft for primary patency are procedures performed for disease beyond the graft and its two anastomoses. | Data were collected retrospectively from health registries, for up to 1 year after index procedure date |
| Peripheral Artery Disease Cohort: Device-related Infection Requiring Reoperation Through 5 Years | Clinical evidence of an infectious process in the direct vicinity of the access site or distal to the treated vascular site classified by the registry investigator as primarily related to the registry device and required surgical intervention | Data were collected retrospectively from health registries, for up to 5 years after index procedure date |
| Dialysis Access Cohort: Primary Patency Through 1 Year | Interval following intervention until the next access thrombosis or repeated intervention. | Data were collected retrospectively from health registries, for up to 1 year after index procedure date |
| Dialysis Access Cohort: Device-related Adverse Events Through 1 Year | Any untoward medical occurrence classified by the registry investigator as primarily related to the registry device | Data were collected retrospectively from health registries, for up to 1 year after index procedure date |
| Besançon |
| France |
| Les Hôpitaux Universitaires de Strasbourg | Strasbourg | France |
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, SOC Chirurgia Vascolare | Ancona | Italy |
| Unità di Chirurgia Vascolare Ospedale San Raffaele | Milan | Italy |
| Chirurgia Vascolare Azienda Ospedaliera Universitaria Integrata Verona | Verona | Italy |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital ClÃnico Universitario San Cecilio | Granada | Spain |
| FG001 | AAA Cohort | Patient underwent simultaneous or staged aortic aneurysm repair (open surgical AAA or TAAA) involving a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts |
| FG002 | Dialysis Access Cohort | Patient required the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease using a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PAD Cohort | Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts |
| BG001 | AAA Cohort | Patient underwent simultaneous or staged aortic aneurysm repair (open surgical AAA or TAAA) involving a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts |
| BG002 | Dialysis Access Cohort | Patient required the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease using a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts |
| BG003 | Total | Total of all reporting groups |
| 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 | Participants |
| |||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PAD Cohort: Primary Safety Outcome: Device-related Seroma or Infection | Clinical evidence of an infectious process in the direct vicinity of the access site or distal to the treated vascular site or seroma classified by the registry investigator as primarily related to the registry device. | Posted | Number | 95% Confidence Interval | percentage of participants | Data were collected retrospectively from health registries, for up to 5 years after index procedure date |
|
|
| ||||||||||||||||||||||||||
| Primary | PAD Cohort: Primary Performance Outcome: Secondary Patency (Revascularization) | Patency of the study graft with additional or secondary surgical or endovascular procedures to restore flow to the graft after occlusion or stenosis of the graft or its anastomoses. The only exceptions that do not disqualify the graft for secondary patency are procedures performed for disease beyond the graft and its two anastomoses. | Posted | Number | 95% Confidence Interval | percentage of participants | Data were collected retrospectively from health registries, for up to 5 years after index procedure date |
|
| |||||||||||||||||||||||||||
| Primary | Aortic Aneurysm Cohort: Primary Safety Outcome: Survival Through 5 Years | All Cause survival | Posted | Number | 95% Confidence Interval | percentage of participants | Data were collected retrospectively from health registries, for up to 5 years after index procedure date |
|
| |||||||||||||||||||||||||||
| Primary | Aortic Aneurysm Cohort: Primary Performance Outcome: Primary Patency Through 5 Years | Patency of the study graft without additional or secondary surgical or endovascular procedures to maintain or restore flow to the graft. The only exceptions that do not disqualify the graft for primary patency are procedures performed for disease beyond the graft and its two anastomoses. | Posted | Number | 95% Confidence Interval | percentage of participants | Data were collected retrospectively from health registries, for up to 5 years after index procedure date |
|
| |||||||||||||||||||||||||||
| Primary | Dialysis Access Cohort: Primary Safety Outcome: Device-related Infection Through 2 Years | Clinical evidence of an infectious process in the direct vicinity of the access site classified by the study investigator as primarily related to the study device. | Posted | Number | 95% Confidence Interval | percentage of participants | Data were collected retrospectively from health registries, for up to 2 years after index procedure date |
|
| |||||||||||||||||||||||||||
| Primary | Dialysis Access Cohort: Useable Access Circuit (Reported as Secondary Patency) Through 2 Years | Patency of the study graft from the time of access creation or placement until access abandonment. | Posted | Number | 95% Confidence Interval | percentage of participants | Data were collected retrospectively from health registries, for up to 2 years after index procedure date |
|
| |||||||||||||||||||||||||||
| Secondary | Peripheral Artery Disease Cohort: Limb Salvage Through 1 Year | Freedom from an amputation above the level of the ankle of the index limb | Posted | Number | 95% Confidence Interval | percentage of participants | Data were collected retrospectively from health registries, for up to 1 year after index procedure date |
|
| |||||||||||||||||||||||||||
| Secondary | Peripheral Artery Disease Cohort: Amputation-free Survival Through 1 Year | Freedom from an amputation above the level of the ankle of the index limb or all cause death | Posted | Number | 95% Confidence Interval | percentage of participants | Data were collected retrospectively from health registries, for up to 1 year after index procedure date |
|
| |||||||||||||||||||||||||||
| Secondary | Peripheral Artery Disease Cohort: Device-related Adverse Events Through 1 Year | Any untoward medical occurrence classified by the registry investigator as primarily related to the registry device | Posted | Number | 95% Confidence Interval | percentage of participants | Data were collected retrospectively from health registries, for up to 1 year after index procedure date |
|
| |||||||||||||||||||||||||||
| Secondary | Peripheral Artery Disease Cohort: Primary Patency Through 1 Year | Patency of the study graft without additional or secondary surgical or endovascular procedures to maintain or restore flow to the graft. The only exceptions that do not disqualify the graft for primary patency are procedures performed for disease beyond the graft and its two anastomoses. | Posted | Number | 95% Confidence Interval | percentage of participants | Data were collected retrospectively from health registries, for up to 1 year after index procedure date |
|
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| Secondary | Peripheral Artery Disease Cohort: Device-related Infection Requiring Reoperation Through 5 Years | Clinical evidence of an infectious process in the direct vicinity of the access site or distal to the treated vascular site classified by the registry investigator as primarily related to the registry device and required surgical intervention | Posted | Number | 95% Confidence Interval | percentage of participants | Data were collected retrospectively from health registries, for up to 5 years after index procedure date |
|
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| Secondary | Dialysis Access Cohort: Primary Patency Through 1 Year | Interval following intervention until the next access thrombosis or repeated intervention. | Posted | Number | 95% Confidence Interval | percentage of participants | Data were collected retrospectively from health registries, for up to 1 year after index procedure date |
|
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| Secondary | Dialysis Access Cohort: Device-related Adverse Events Through 1 Year | Any untoward medical occurrence classified by the registry investigator as primarily related to the registry device | Posted | Number | 95% Confidence Interval | percentage of participants | Data were collected retrospectively from health registries, for up to 1 year after index procedure date |
|
|
Adverse event data were collected retrospectively from health registries, for up to 5 years after index procedure date
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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 | PAD Cohort | Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts | 54 | 145 | 130 | 145 | 8 | 145 |
| EG001 | AAA Cohort | Patient underwent simultaneous or staged aortic aneurysm repair (open surgical AAA or TAAA) involving a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts | 12 | 65 | 50 | 65 | 11 | 65 |
| EG002 | Dialysis Access Cohort | Patient required the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease using a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts | 27 | 146 | 101 | 146 | 12 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute anemia | Blood and lymphatic system disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Agranulocytosis | Blood and lymphatic system disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Bicytopenia | Blood and lymphatic system disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Paratracheal lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Acute heart failure | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Atrioventricular block | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Atrioventricular block third degree | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Cardio-respiratory failure | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Cardiopulmonary arrest | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Congestive heart failure | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Coronary artery disease progression | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Coronary heart disease | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Coronary ostial stenosis | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Decompensated heart failure | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Decompensation cardiac | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Heart attack | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Heart failure | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Left cardiac failure | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Multiple vessel coronary artery disease | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Non ST segment elevation acute coronary syndrome | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Paroxysmal atrial fibrillation | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Persistent atrial fibrillation | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Silent myocardial ischemia | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Polycystic hepatorenal disease | Congenital, familial and genetic disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Multinodular goiter | Endocrine disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Abnormal vision | Eye disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Rhegmatogenous retinal detachment | Eye disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Abdominal compartment syndrome | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Bowel obstruction | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Digestion impaired | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Epigastric hernia | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Haemorrhage of digestive tract | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Hemoperitoneum | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Hemorrhage intraabdominal | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Hemorrhage of digestive tract | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Intestinal bleeding | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Intestinal ischaemia | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Intestinal ischemia | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Intestinal necrosis | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Intra-abdominal hematoma | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Ischemic colitis | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Jejunal hemorrhage | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Melena | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Mesenteric ischemia | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Necrotising colitis | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Rectal bleeding | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Rectal disorder | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Retroperitoneal hematoma | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Sessile colonic polyp | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Superior mesenteric artery dissection | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Terminal ileitis | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Calf swelling | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Fever | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| General physical condition decreased | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Groin swelling | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Hematoma injection site | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Hernia pain | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Impaired healing | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Implant site hematoma | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Implant site seroma | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| In-stent venous stenosis | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Multi organ failure | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Multiple organ failure | General disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Necrosis | General disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Reduced general condition | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Stent stenosis | General disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Stent thrombosis | General disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Systemic inflammatory response syndrome | General disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Unknown cause of death | General disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Upper limb oedema | General disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Vascular stent-graft stenosis | General disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Walking difficulty | General disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Wound healing delayed | General disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute cholecystitis | Hepatobiliary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Calculous cholecystitis | Hepatobiliary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Kidney transplant rejection | Immune system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Abscess on buttock | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute pyelonephritis | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Arteriovenous fistula infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Arteriovenous graft site infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Aspiration pneumonia | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Epididymo-orchitis | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Epiduritis | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Foot abscess | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Gangrene toe | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Infected fistula | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Inguinal infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Mediastinitis | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Oral thrush | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Osteomyelitis of the foot | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pilonidal sinus | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pseudoaneurysm infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pseudomonal bacteremia | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Renal cyst infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Respiratory infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Schistosomiasis bladder | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Septic arthritis | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Septicemia | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Subcutaneous infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Surgical site infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Surgical wound infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Urinary infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Vascular graft infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Vascular stent infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Achilles tendon rupture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute subdural hematoma | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Arterial bypass occlusion | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Arteriovenous fistula site bleeding | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Arteriovenous fistula site hematoma | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Arteriovenous fistula site stenosis | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Arteriovenous graft site pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Contusion of knee | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Drug overdose | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| False aneurysm | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Fascial rupture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Femoral artery restenosis | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Fracture vertebral | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Fractured thumb | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hand injury | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Incision site bleeding | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Incision site hematoma | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Incision site hemorrhage | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Intraoperative hemorrhage | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Laceration of face | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Lower limb wound | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Lumbar spine compression fracture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Post procedural bleeding | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Postoperative bleeding | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Postoperative haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Postoperative wound necrosis | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Procedural bleeding | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Spinal cord injury | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Subcutaneous hematoma | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Surgical wound dehiscence | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Trochanteric femoral fracture | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Vascular access site bleeding | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Vascular access site hematoma | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Vascular access site necrosis | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Vascular access site pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Vascular access site thrombosis | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Vascular access steal syndrome | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Vascular graft stenosis | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| Wound pain | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pedal pulse absent | Investigations | MedDRA Version 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hyperosmolar hyperglycaemic syndrome | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Water retention | Metabolism and nutrition disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Foot pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Haematoma muscle | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hips osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Leg pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Osteoarthritis aggravated | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Osteoarthritis knee | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pain in leg | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pain in limb | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pain in toe | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Rotator cuff tear | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute myeloid leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Antral carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Bone metastases | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Colon adenomatous polyp | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Colonic tubular adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Esophageal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hemangioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Intraductal papillary mucinous neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Kidney tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Metastatic squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Myelodysplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Prostate adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of head and neck | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Tumor compression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.0 | Systematic Assessment |
| |
| Amputation stump pain | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Cerebral embolism | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Cerebral hematoma | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Cognitive impairment | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Cruralgia | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Fainting | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hemorrhagic stroke | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Internal carotid artery stenosis | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Senile dementia | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Stroke | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Syncopal attack | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Unilateral carpal tunnel syndrome | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA Version 27.0 | Systematic Assessment |
| |
| Stent occlusion | Product Issues | MedDRA Version 27.0 | Systematic Assessment |
| |
| Thrombosis in device | Product Issues | MedDRA Version 27.0 | Systematic Assessment |
| |
| Anxiety depression | Psychiatric disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Confusion state | Psychiatric disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute kidney failure | Renal and urinary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute renal insufficiency | Renal and urinary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Chronic renal failure | Renal and urinary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Renal cyst hemorrhage | Renal and urinary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Renal failure aggravated | Renal and urinary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Renal insufficiency | Renal and urinary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Renal insufficiency aggravated | Renal and urinary disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Sexual dysfunction | Reproductive system and breast disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute respiratory decompensation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Basilar atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Bronchial congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Dyspnea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Lung nodule | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Nosebleed | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Ankle ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Blistering | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Bullous pemphigoid | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Foot ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Ischemic wound | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Leg ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Pressure ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Below knee amputation | Surgical and medical procedures | MedDRA Version 27.0 | Systematic Assessment |
| |
| Transmetatarsal amputation | Surgical and medical procedures | MedDRA Version 27.0 | Systematic Assessment |
| |
| Abdominal aortic aneurysm hemorrhage | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute limb ischaemia | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Acute limb ischemia | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Aneurysm thrombosis | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Aortic rupture | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Arterial aneurysm | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Chronic limb ischaemia | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Chronic limb-threatening ischemia | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Claudication | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Critical limb ischaemia | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Critical limb ischemia | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Cyanosis peripheral | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Digital necrosis | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| External iliac artery stenosis | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Femoral artery dissection | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Femoral artery occlusion | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Femoral artery stenosis | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Groin hematoma | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Haemorrhagic shock | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Hematoma | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Hemorrhagic shock | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Hypovolemic shock | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Iliac artery dissection | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Iliac artery stenosis | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Ischemic limb pain | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Leg ischemia | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Lower limb ischaemia | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Lower limb ischemia | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Lymphedema | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Peripheral vein stenosis | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Popliteal artery aneurysm | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Popliteal artery aneurysm enlargement | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Steal syndrome | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Subclavian artery stenosis | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Superficial femoral artery occlusion | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Type A aortic dissection | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Type B aortic dissection | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Uncontrolled hypertension | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Vascular insufficiency | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Venous bleeding | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Venous stenosis | Vascular disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
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| Anemia postoperative | Injury, poisoning and procedural complications | MedDRA Version 27.0 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA Version 27.0 | Systematic Assessment |
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| Acute renal insufficiency | Renal and urinary disorders | MedDRA Version 27.0 | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Austin Phillips | W. L. Gore & Associates | +1 928 864 3641 | agphilli@wlgore.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 7, 2022 | Mar 12, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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