Valiant Evo US Clinical Trial | NCT02652949 | Trialant
NCT02652949
Sponsor
Medtronic Cardiovascular
Status
Completed
Last Update Posted
Apr 9, 2024Actual
Enrollment
100Actual
Phase
Not Applicable
Conditions
Aortic Aneurysm, Thoracic
Interventions
Valiant Evo Thoracic Stent Graft System
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02652949
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
10219498DOC
Secondary IDs
ID
Type
Description
Link
NCT02652949
Other Identifier
ClinicalTrials.gov
Brief Title
Valiant Evo US Clinical Trial
Official Title
Valiant Evo US Clinical Trial
Acronym
VEVO
Organization
Medtronic CardiovascularINDUSTRY
Status Module
Record Verification Date
Mar 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2016Actual
Primary Completion Date
Dec 2017Actual
Completion Date
Mar 2, 2023Actual
First Submitted Date
Jan 8, 2016
First Submission Date that Met QC Criteria
Jan 8, 2016
First Posted Date
Jan 12, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 10, 2018
Results First Submitted that Met QC Criteria
Feb 7, 2019
Results First Posted Date
Feb 26, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 15, 2024
Last Update Posted Date
Apr 9, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Medtronic CardiovascularINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
Yes
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the Valiant Evo US Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.
Detailed Description
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 total subjects, in order to obtain 87 evaluable subjects for the primary endpoint. The two protocols are identical, and the trials were run simultaneously to enroll subjects concurrently in the United States (US) and Outside United States (OUS). The poolability on the primary endpoint between US and OUS data will be assessed using Fisher's exact test during the data analysis. Data for both trials will be combined and presented as a pooled analysis.
Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure
MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture.
Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries.
Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system.
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test.
30 Days
Secondary Outcomes
Measure
Description
Time Frame
Safety and Effectiveness Outcome
Safety and Effectiveness outcome measures between 0-30 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]).
Measures include: peri-operative mortality, adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, and endoleaks.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subject is ≥18 years old.
Subject understands and voluntarily has signed and dated the Informed Consent Form approved by the Sponsor and by the Ethics Committee for this study.
Subject presents a Descending Thoracic Aortic Aneurysm (DTAA) which is localized below the ostium of Left Subclavian Artery (LSA) and above the ostium of celiac trunk
Subject has a DTAA that is one of the following:
A fusiform aneurysm with a maximum diameter that:
is ≥ 50 mm and/or:
is > 2 times the diameter of the non-aneurysmal thoracic aorta and/or:
is < 50 mm and has grown ≥ 5 mm within previous 12 months
A saccular aneurysm or a penetrating atherosclerotic ulcer
Subject's anatomy must meet all of the following anatomical criteria as demonstrated on contrast-enhanced CT and/or on contrast-enhanced Magnetic Resonance Angiogram (MRA) obtained within four (4) months prior to implant procedure:
Proximal and distal non-aneurysmal aortic neck diameter measurements must be ≥ 16 mm and ≤ 42 mm;
Proximal non-aneurysmal aortic neck length must be ≥ 20 mm (for FreeFlo configuration) and ≥ 25 mm (for Closed Web configuration) distal to the left common carotid artery (LCCA). Note: Proximal aortic neck length may include covering the LSA (with or without discretionary revascularization) when necessary to optimize device fixation and maximize aortic neck length. If occlusion of the LSA ostium is required to obtain adequate neck length for fixation and sealing, transposition or bypass to the LSA may be warranted.
Distal non-aneurysmal aortic neck length must be ≥ 20 mm
Subject has adequate arterial access site or can tolerate a conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate sized device chosen for the treatment.
Exclusion Criteria:
Subject has a life expectancy of less than 1 year
Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study.
Subject is pregnant.
Subject requires planned placement of the covered proximal end of the stent graft to occur in zones 0 or 1.
Subject has a thoracic aneurysm with a contained rupture or localized at the anastomosis of a previous graft (pseudo-/false aneurysm).
Subject has a mycotic aneurysm.
Subject has a dissection (type A or B) or an intramural hematoma or an aortic rupture in addition to the thoracic aneurysm.
Subject requires emergent aneurysm treatment, e.g., trauma or rupture.
Subject has received a previous stent or stent graft or previous surgical repair in the ascending and/or descending thoracic aorta, and/or in the aortic arch.
Subject requires surgical or endovascular treatment of an infra-renal aneurysm at the time of implant
Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm.
Treatment with the Valiant Evo Thoracic Stent Graft would require intentional revascularization of the brachio-cephalic artery or the left common carotid artery or the celiac trunk.
Subject has had or plans to have a major surgical or interventional procedure within 30 days before or 30 days after the planned implantation of the Valiant Evo Thoracic Stent Graft. This does not include planned procedures that are needed for the safe and effective placement of the stent graft (i.e., carotid/subclavian transposition, carotid/subclavian bypass procedure).
Subject has a significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that could compromise fixation and seal of the implanted stent graft.
Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration).
Subject has a bleeding diathesis or coagulopathy, or refuses blood transfusion.
Subject has had a Myocardial Infarction (MI) within 3 months of the procedure.
Subject has had a Cerebrovascular Accident (CVA) within 3 months of the procedure.
Subject has a known allergy or intolerance to the device materials
Subject has a known allergy to anesthetic drugs
Subject has a known hypersensitivity or contraindication to anticoagulants, or contrast media, which is not amenable to pretreatment.
Subject has active or systemic infection at the time of the index procedure.
Verzini F, Cieri E, Kahlberg A, Sternbach Y, Heijmen R, Ouriel K, Robaina S, Azizzadeh A. A preliminary analysis of late structural failures of the Navion stent graft in the treatment of descending thoracic aortic aneurysms. J Vasc Surg. 2021 Oct;74(4):1125-1134.e2. doi: 10.1016/j.jvs.2021.04.018. Epub 2021 Apr 20.
A total of 152 subjects were consented to be reviewed for enrollment. 52 subjects were not approved for implantation, 100 subjects were approved for implantation. The 30-day primary endpoint was evaluated when 87 subjects completed 30-day follow-up.
Recruitment Details
100 subjects (53 US, 47 Outside US [OUS]), from 18 US sites and 15 OUS sites, contributed to the global cohort. The 1st subject was enrolled on 25/APRIL/2016, the 100th subject on 28/MARCH/2018.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Endovascular Repair
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysms (DTAA) and who met the inclusion and exclusion criteria.
Periods
Title
Milestones
Reasons Not Completed
30-Day Follow-up for Primary Endpoint
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 20, 2017
Dec 9, 2018
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
30 Days
Safety and Effectiveness Outcome
Safety outcome measures between 0-183 days and Effectiveness outcome measures between 31-183 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
6 month
Safety and Effectiveness Outcome
Safety outcome measures between 0-365 days and Effectiveness outcome measures between 184-365 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
12 Month
Safety and Effectiveness Outcome
Safety outcome measures between 0-730 days and Effectiveness outcome measures between 366-730 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
24 Month
Safety and Effectiveness Outcome
Safety outcome measures between 0-1095 days and Effectiveness outcome measures between 731-1095 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
36 Month
Safety and Effectiveness Outcome
Safety outcome measures between 0-1460 days and Effectiveness outcome measures between 1096-1460 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."
48 Month
Safety and Effectiveness Outcome
Safety and Effectiveness outcome measures between implant procedure and 60 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
60 Month
Stanford
California
94305
United States
Medstar Washington Hospital Center
Washington D.C.
District of Columbia
20010
United States
University of Florida
Gainesville
Florida
32610
United States
Emory University Hospital
Atlanta
Georgia
30322
United States
University of Michigan Health System
Ann Arbor
Michigan
48109
United States
University of Minnesota Medical Center
Minneapolis
Minnesota
55455
United States
Barnes Jewish Hospital
St Louis
Missouri
63110
United States
Albany Medical Center
Albany
New York
12208
United States
University of North Carolina
Chapel Hill
North Carolina
27514
United States
Carolinas Medical Center
Charlotte
North Carolina
28203
United States
Duke University Medical Center
Durham
North Carolina
27710
United States
Cleveland Clinic
Cleveland
Ohio
44195
United States
Ohio State University
Columbus
Ohio
43210
United States
OhioHealth Riverside Methodist Hospital
Columbus
Ohio
43214
United States
University of Pennsylvania
Philadelphia
Pennsylvania
19104
United States
Memorial Hermann Texas Medical Center
Houston
Texas
77030
United States
The Heart Hospital Baylor Plano
Plano
Texas
75093
United States
University of Virginia Medical Center
Charlottesville
Virginia
22908
United States
Inova Fairfax Hospital
Falls Church
Virginia
22042
United States
Sentara Norfolk General Hospital
Norfolk
Virginia
23507
United States
Azizzadeh A, Desai N, Arko FR 3rd, Panneton JM, Thaveau F, Hayes P, Dagenais F, Lei L, Verzini F. Pivotal results for the Valiant Navion stent graft system in the Valiant EVO global clinical trial. J Vasc Surg. 2019 Nov;70(5):1399-1408.e1. doi: 10.1016/j.jvs.2019.01.067. Epub 2019 May 21.
FG00087 subjectsThe 30-day primary endpoint was evaluated when 87 subjects completed 30-day follow-up.
COMPLETED
FG00086 subjects
NOT COMPLETED
FG0001 subjects
Type
Comment
Reasons
Death
FG0001 subjects
30-Day Follow-up for Secondary Endpoint
Type
Comment
Milestone Data
STARTED
FG000100 subjectsThe 30-day secondary endpoint was evaluated when 100 subjects completed 30-day follow-up.
COMPLETED
FG00099 subjects
NOT COMPLETED
FG0001 subjects
Type
Comment
Reasons
Death
FG0001 subjects
6-Month Follow-up Secondary Endpoint
Type
Comment
Milestone Data
STARTED
FG00099 subjectsNote that 6-month follow up is not mandatory for OUS subjects.
COMPLETED
FG00091 subjects
NOT COMPLETED
FG0008 subjects
Type
Comment
Reasons
Death
FG0005 subjects
Withdrawal by Subject
FG0002 subjects
Lost to Follow-up
FG0001 subjects
12-Month Follow-up Secondary Endpoint
Type
Comment
Milestone Data
STARTED
FG00091 subjects
COMPLETED
FG00087 subjects
NOT COMPLETED
FG0004 subjects
Type
Comment
Reasons
Death
FG0004 subjects
24-Month Follow-up Secondary Endpoint
Type
Comment
Milestone Data
STARTED
FG00087 subjects
COMPLETED
FG00052 subjects
NOT COMPLETED
FG00035 subjects
Type
Comment
Reasons
Death
FG0002 subjects
Withdrawal by Subject
FG0003 subjects
Lost to Follow-up
FG0002 subjects
36-Month Follow-up Secondary Endpoint
Type
Comment
Milestone Data
STARTED
FG00052 subjects
COMPLETED
FG00048 subjects
NOT COMPLETED
FG0004 subjects
Type
Comment
Reasons
Death
FG0002 subjects
Withdrawal by Subject
FG0002 subjects
48-Month Follow-up Secondary Endpoint
Type
Comment
Milestone Data
STARTED
FG00048 subjects
COMPLETED
FG00042 subjects
NOT COMPLETED
FG0006 subjects
Type
Comment
Reasons
Death
FG0004 subjects
Lost to Follow-up
FG0001 subjects
Withdrawal by Subject
FG0001 subjects
60-Month Follow-up Secondary Endpoint
Type
Comment
Milestone Data
STARTED
FG00042 subjects
COMPLETED
FG00036 subjects
NOT COMPLETED
FG0006 subjects
Type
Comment
Reasons
Death
FG0005 subjects
Withdrawal by Subject
FG0001 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Endovascular Repair
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm (DTAA) and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]).
Denominators
Units
Counts
Participants
BG000100
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG000100
Title
Measurements
BG00070.8± 8.9
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000100
Title
Measurements
Female
BG00040
Male
Race/Ethnicity, Customized
Race data were not collected in OUS per regulation
Count of Participants
Participants
Title
Denominators
Categories
Number Analyzed
ParticipantsBG00053
Title
Measurements
White
BG000
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
ParticipantsBG000100
Title
Measurements
BG00053
Canada
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
Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure
MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture.
Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries.
Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system.
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test.
The 30-day primary endpoint was evaluated for Pre-Market Approval (PMA) approval when 87 subjects completed 30 day follow-up.
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects (52 US, 35 OUS).
Units
Counts
Participants
OG00087
Title
Denominators
Categories
Title
Measurements
OG0002
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:
H0: p ≥ 16% vs. Ha: p <16%, where p denotes the true event rate of primary study endpoint in the target population.
Exact binomial test
<0.0001
Event rate
0.023
1-Sided
97.5
0.081
Superiority
Secondary
Safety and Effectiveness Outcome
Safety and Effectiveness outcome measures between 0-30 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]).
Measures include: peri-operative mortality, adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, and endoleaks.
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Posted
Count of Participants
Participants
30 Days
ID
Title
Description
OG000
Endovascular Repair
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Units
Counts
Participants
OG000
Secondary
Safety and Effectiveness Outcome
Safety outcome measures between 0-183 days and Effectiveness outcome measures between 31-183 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International Trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US).
Note that 6-month follow up is not mandatory for subjects enrolled under the Valiant Evo International protocol, resulting in fewer subjects analyzed at 6 months.
Posted
Count of Participants
Participants
6 month
ID
Title
Description
OG000
Endovascular Repair
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US).
Secondary
Safety and Effectiveness Outcome
Safety outcome measures between 0-365 days and Effectiveness outcome measures between 184-365 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Posted
Count of Participants
Participants
12 Month
ID
Title
Description
OG000
Endovascular Repair
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Units
Counts
Participants
Secondary
Safety and Effectiveness Outcome
Safety outcome measures between 0-730 days and Effectiveness outcome measures between 366-730 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Posted
Count of Participants
Participants
24 Month
ID
Title
Description
OG000
Endovascular Repair
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Secondary
Safety and Effectiveness Outcome
Safety outcome measures between 0-1095 days and Effectiveness outcome measures between 731-1095 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Posted
Count of Participants
Participants
36 Month
ID
Title
Description
OG000
Endovascular Repair
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Secondary
Safety and Effectiveness Outcome
Safety outcome measures between 0-1460 days and Effectiveness outcome measures between 1096-1460 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Posted
Count of Participants
Participants
48 Month
ID
Title
Description
OG000
Endovascular Repair
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Secondary
Safety and Effectiveness Outcome
Safety and Effectiveness outcome measures between implant procedure and 60 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.
Measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US).
Posted
Count of Participants
Participants
60 Month
ID
Title
Description
OG000
Endovascular Repair
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US).
Units
Counts
Time Frame
Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Endovascular Repair 30-Day Secondary Endpoint
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality, or one or more serious adverse event within 0-30 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 30-Day time period or were followed for at least 1 day.
For Adverse Events, the 30-Day time period for reporting is 0-30 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 30-Day time interval.
2
100
32
100
62
100
EG001
Endovascular Repair 6-Month Secondary Endpoint
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-183 days, or one or more serious adverse event within 31-183 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 6-Month time period or were followed for at least 91 days.
For Adverse Events, the 6-Month time period for reporting is 31-183 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 6-Month time interval.
6
99
27
98
32
98
EG002
Endovascular Repair 12-Month Secondary Endpoint
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-365 days, or one or more serious adverse event within 184-365 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 12-Month time period or were followed for at least 305 days.
For Adverse Events, the 12-Month time period for reporting is 184-365 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 12-Month time interval.
10
97
22
91
20
91
EG003
Endovascular Repair 24-Month Secondary Endpoint
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-730 days, or one or more serious adverse event within 366-730 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 24-Month time period or were followed for at least 549 days.
For Adverse Events, the 24-Month time period for reporting is 366-730 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 24-Month time interval.
13
80
17
84
21
84
EG004
Endovascular Repair 36-Month Secondary Endpoint
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-1095 days, or one or more serious adverse event within 731-1095 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 36-Month time period or were followed for at least 914 days.
For Adverse Events, the 36-Month time period for reporting is 731-1095 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 36-Month time interval.
14
78
14
66
14
66
EG005
Endovascular Repair 48-Month
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-1460 days, or one or more serious adverse event within 1096-1460 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 48-Month time period or were followed for at least 1279 days.
For Adverse Events, the 48-Month time period for reporting is 1096-1460 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 48-Month time interval.
20
71
17
62
16
62
EG006
Endovascular Repair 60-Month
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-1825 days, or one or more serious adverse event within 1461-1825 days Procedure: thoracic endovascular aneurysm repair (TEVAR) For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 60-Month time period or were followed for at least 1644 days.
For Adverse Events, the 60-Month time period for reporting is 1461-1825 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 60-Month time interval.
23
66
15
49
14
49
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0012 affected98 at risk
EG0020 affected91 at risk
EG0030 affected84 at risk
EG0040 affected66 at risk
EG0050 affected62 at risk
EG0060 affected49 at risk
Anaemia of Chronic Disease
Blood and lymphatic system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Blood Loss Anaemia
Blood and lymphatic system disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Microcytic Anaemia
Blood and lymphatic system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Splenic Lesion
Blood and lymphatic system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Angina Unstable
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA25
Systematic Assessment
EG0003 affected100 at risk
EG0012 affected98 at risk
EG0021 affected91 at risk
EG003
Atrioventricular Block
Cardiac disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0011 affected98 at risk
EG0021 affected91 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Coronary Artery Dissection
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Coronary Artery Occlusion
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Ischaemic Cardiomyopathy
Cardiac disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Left Ventricular Failure
Cardiac disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Sinus Node Dysfunction
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Ventricular Fibrillation
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Ventricular Tachycardia
Cardiac disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Retinal Detachment
Eye disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Abdominal Hernia
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Anal Incontinence
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Change of Bowel Habit
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Colitis Ischaemic
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Fistula of Small Intestine
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Haemorrhoidal Haemorrhage
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Intestinal Strangulation
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Peptic Ulcer Haemorrhage
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Death
General disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Pyrexia
General disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Stent-Graft Endoleak
General disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Vascular Stent Thrombosis
General disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Anaphylactic Shock
Immune system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Bacterial Sepsis
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Bronchitis
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Intervertebral Discitis
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Localised Infection
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Pneumonia
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0013 affected98 at risk
EG0025 affected91 at risk
EG003
Pneumonia Aspiration
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Pulmonary Sepsis
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Sepsis
Infections and infestations
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0012 affected98 at risk
EG0022 affected91 at risk
EG003
Septic Shock
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Urinary Tract Infection Bacterial
Infections and infestations
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Urinary Tract Infection Staphylococcal
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Urosepsis
Infections and infestations
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Vascular Device Infection
Infections and infestations
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Cervical Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Facial Bones Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Femoral Neck Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Hip Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Incomplete Spinal Fusion
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Post Lumbar Puncture Syndrome
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Postoperative Delirium
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Respiratory Tract Procedural Complication
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Spinal Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Tibia Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Tracheal Haemorrhage
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Vascular Access Site Thrombosis
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Vascular Pseudoaneurysm
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Wound Dehiscence
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Weight Decreased
Investigations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Failure to Thrive
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Vitamin D Deficiency
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Pseudarthrosis
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Adenocarcinoma Pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Bladder Cancer Recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Intraductal Papillary Mucinous Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Lung Squamous Cell Carcinoma Stage Iii
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Metastatic Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Myeloproliferative Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Oesophageal Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Renal Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Cerebellar Infarction
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Cerebral Infarction
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Dementia with Lewy Bodies
Nervous system disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Drug Withdrawal Convulsions
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Embolic Stroke
Nervous system disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Guillain-Barre Syndrome
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Ischaemic Stroke
Nervous system disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Lacunar Stroke
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Metabolic Encephalopathy
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Paraplegia
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Parkinson's Disease
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Spinal Cord Ischaemia
Nervous system disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Syncope
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0021 affected91 at risk
EG003
Vascular Encephalopathy
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Device Breakage
Product Issues
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Delirium Tremens
Psychiatric disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Depression
Psychiatric disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Mental Status Changes
Psychiatric disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Suicidal Ideation
Psychiatric disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0012 affected98 at risk
EG0022 affected91 at risk
EG003
End Stage Renal Disease
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Renal Tubular Necrosis
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Ureteric Obstruction
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Urinary Bladder Polyp
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0013 affected98 at risk
EG0021 affected91 at risk
EG003
Chylothorax
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Pulmonary Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Pulmonary Fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Pulmonary Hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Pulmonary Mass
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Respiratory Distress
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Aortic Aneurysm
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0012 affected98 at risk
EG0021 affected91 at risk
EG003
Aortic Dissection
Vascular disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Aortic Rupture
Vascular disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Atheroembolism
Vascular disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Hypertension
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Hypertensive Urgency
Vascular disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Iliac Artery Dissection
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Iliac Artery Stenosis
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Orthostatic Hypotension
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0012 affected98 at risk
EG0021 affected91 at risk
EG003
Peripheral Arterial Occlusive Disease
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Peripheral Artery Occlusion
Vascular disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Peripheral Artery Thrombosis
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Peripheral Embolism
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Peripheral Ischaemia
Vascular disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Complication Associated With Device
General disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Postoperative Wound Infection
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Wound Infection
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Laryngeal Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Lung Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Ischaemic Cerebral Infarction
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Device Physical Property Issue
Product Issues
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Hypertensive Emergency
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA25
Systematic Assessment
EG0008 affected100 at risk
EG0012 affected98 at risk
EG0021 affected91 at risk
EG0030 affected84 at risk
EG0040 affected66 at risk
EG0050 affected62 at risk
EG0060 affected49 at risk
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA25
Systematic Assessment
EG0005 affected100 at risk
EG0012 affected98 at risk
EG0020 affected91 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA25
Systematic Assessment
EG0003 affected100 at risk
EG0012 affected98 at risk
EG0020 affected91 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Aortic Valve Stenosis
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0011 affected98 at risk
EG0021 affected91 at risk
EG003
Atrial Flutter
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Atrial Tachycardia
Cardiac disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Atrioventricular Block First Degree
Cardiac disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0012 affected98 at risk
EG0022 affected91 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA24
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Hypertensive Cardiomyopathy
Cardiac disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Left Ventricular Failure
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Palpitations
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0022 affected91 at risk
EG003
Pericardial Effusion
Cardiac disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Sinus Bradycardia
Cardiac disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Supraventricular Tachycardia
Cardiac disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Torsade De Pointes
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Ventricular Extrasystoles
Cardiac disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Ventricular Tachycardia
Cardiac disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Atrial Septal Defect
Congenital, familial and genetic disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Congenital Hypercoagulation
Congenital, familial and genetic disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Gastrointestinal Arteriovenous Malformation
Congenital, familial and genetic disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Loeys-Dietz Syndrome
Congenital, familial and genetic disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Chondrodermatitis Nodularis Chronica Helicis
Ear and labyrinth disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Cataract
Eye disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Visual Impairment
Eye disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Abdominal Tenderness
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Abdominal Wall Haematoma
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0003 affected100 at risk
EG0011 affected98 at risk
EG0021 affected91 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Gastrointestinal Angiectasia
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0021 affected91 at risk
EG003
Hiatus Hernia
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Presbyoesophagus
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Asthenia
General disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Chest Pain
General disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Facial Pain
General disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Fatigue
General disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0011 affected98 at risk
EG0021 affected91 at risk
EG003
Generalised Oedema
General disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Influenza Like Illness
General disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Injury Associated With Device
General disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Oedema
General disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Oedema Peripheral
General disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Peripheral Swelling
General disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Puncture Site Haemorrhage
General disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Pyrexia
General disorders
MedDRA25
Systematic Assessment
EG0006 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Stent-Graft Endoleak
General disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Cellulitis
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Central Nervous System Infection
Infections and infestations
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Clostridium Difficile Colitis
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Covid-19
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Epididymitis
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Groin Abscess
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Influenza
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Oesophageal Candidiasis
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Pneumonia
Infections and infestations
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0013 affected98 at risk
EG0021 affected91 at risk
EG003
Pneumonia Staphylococcal
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Post Procedural Sepsis
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Skin Infection
Infections and infestations
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA25
Systematic Assessment
EG0007 affected100 at risk
EG0013 affected98 at risk
EG0021 affected91 at risk
EG003
Anaemia Postoperative
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Aortic Injury
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Bone Contusion
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Cervical Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Corneal Abrasion
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Incision Site Erythema
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Incision Site Pain
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Joint Dislocation
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Ligament Rupture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Periorbital Haematoma
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Post Procedural Fever
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0003 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Postimplantation Syndrome
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Postoperative Delirium
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Postoperative Respiratory Failure
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0003 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Procedural Haemorrhage
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Procedural Hypotension
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Procedural Site Reaction
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Seroma
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Sternal Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Traumatic Haematoma
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Vascular Access Site Complication
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Vascular Access Site Haematoma
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Vascular Access Site Haemorrhage
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Vascular Pseudoaneurysm
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Wound Dehiscence
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Blood Creatine Phosphokinase Increased
Investigations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Blood Magnesium Decreased
Investigations
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Oxygen Saturation Decreased
Investigations
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Troponin I Increased
Investigations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Troponin Increased
Investigations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Urine Output Decreased
Investigations
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Electrolyte Imbalance
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Hyperlipasaemia
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0005 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Joint Swelling
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Bowen's Disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Lung Neoplasm Malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Renal Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Asterixis
Nervous system disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Carotid Artery Dissection
Nervous system disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Carotid Artery Stenosis
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Dizziness
Nervous system disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Headache
Nervous system disorders
MedDRA25
Systematic Assessment
EG0003 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Morton's Neuralgia
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Neurological Decompensation
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Parkinson's Disease
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Presyncope
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Radial Nerve Palsy
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Spinal Cord Infarction
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Spinal Subarachnoid Haemorrhage
Nervous system disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Delirium
Psychiatric disorders
MedDRA25
Systematic Assessment
EG0003 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Depression
Psychiatric disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Mental Status Changes
Psychiatric disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0003 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Chronic Kidney Disease
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0012 affected98 at risk
EG0020 affected91 at risk
EG003
Cystitis Haemorrhagic
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Focal Segmental Glomerulosclerosis
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Renal Ischaemia
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Renal Mass
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0003 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0005 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0012 affected98 at risk
EG0020 affected91 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Diaphragmatic Paralysis
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Hypercapnia
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Lung Consolidation
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Lung Infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Lung Opacity
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Painful Respiration
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG00012 affected100 at risk
EG0011 affected98 at risk
EG0021 affected91 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Pleuritic Pain
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Pulmonary Mass
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Pulmonary Oedema
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0002 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Respiratory Acidosis
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Decubitus Ulcer
Skin and subcutaneous tissue disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Drug Eruption
Skin and subcutaneous tissue disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Keloid Scar
Skin and subcutaneous tissue disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Skin Reaction
Skin and subcutaneous tissue disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Aortic Aneurysm
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Aortic Dissection
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0012 affected98 at risk
EG0020 affected91 at risk
EG003
Haematoma
Vascular disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Hypertension
Vascular disorders
MedDRA25
Systematic Assessment
EG0007 affected100 at risk
EG0014 affected98 at risk
EG0020 affected91 at risk
EG003
Hypotension
Vascular disorders
MedDRA25
Systematic Assessment
EG0004 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Jugular Vein Thrombosis
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Penetrating Aortic Ulcer
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Penetrating Atherosclerotic Ulcer
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Peripheral Arterial Occlusive Disease
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0011 affected98 at risk
EG0020 affected91 at risk
EG003
Peripheral Artery Haematoma
Vascular disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Peripheral Embolism
Vascular disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Peripheral Ischaemia
Vascular disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Subclavian Artery Stenosis
Vascular disorders
MedDRA25
Systematic Assessment
EG0001 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Subclavian Artery Thrombosis
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Angina Unstable
Blood and lymphatic system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Congenital Aortic Valve Incompetence
Congenital, familial and genetic disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Tympanic Membrane Perforation
Ear and labyrinth disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Lower Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0021 affected91 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Retroperitoneal Haematoma
Gastrointestinal disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Adverse Drug Reaction
General disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Impaired Self-Care
General disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Popliteal Pulse Increased
Investigations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Laryngeal Nerve Palsy
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Vocal Cord Paralysis
Nervous system disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Bladder Hypertrophy
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Aortic Dilatation
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Subclavian Artery Dissection
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Vascular Wall Hypertrophy
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Peripheral Artery Stenosis
Vascular disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Atypical Pneumonia
Infections and infestations
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Renal Arteriosclerosis
Renal and urinary disorders
MedDRA25
Systematic Assessment
EG0000 affected100 at risk
EG0010 affected98 at risk
EG0020 affected91 at risk
EG003
Clinical evidence collected as part of the Valiant Evo US Clinical Trial (NCT02652949) and the Valiant Evo International Clinical Trial (NCT02625324) are combined to support commercial marketing approvals.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Medtronic owns the data of this clinical study, a single investigation site may access and use the data provided by itself for scientific publications following prior approval by Medtronic.
Pooling data from several investigation sites for publication purposes, national projects and international projects all require prior approval from Medtronic.