Evaluation of the GORE® TBE Device in the Treatment of Le... | NCT02777593 | Trialant
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Studies Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2 NCT02777593 Show options Aortic Aneurysm, Thoracic Aorta; Lesion GORE® TAG® Thoracic Branch Endoprosthesis Obsolete or Duplicate NCT IDs Not provided
SSB 11-02 Pivotal (Zone 2)
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
W.L.Gore & Associates INDUSTRY
Overall Recruitment Status or Expanded Access Status Active, not recruiting
First Submission Date that Met QC Criteria May 16, 2016
Results First Submitted Date Aug 3, 2022
Results First Submitted that Met QC Criteria Nov 1, 2022
Results First Posted Date Nov 22, 2022 Actual
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 Feb 23, 2026
Responsible Party, by Official Title Sponsor
W.L.Gore & Associates INDUSTRY
Has Data Monitoring Committee (DMC) Yes
Pediatric Postmarket Surveillance of a Device Product Not provided
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta, requiring Zone 2 proximal implantation of the device.
For Zone 2, there are two arms (Aneurysm arm, Non-aneurysm arm) and four cohorts, described as follows: Zone 2 Aneurysm, Zone 2 Dissection, Zone 2 Traumatic Transection, and Zone 2 Other Isolated Lesion. Continued access Subjects were enrolled in the Zone 2 Aneurysm arm. The Zone 2 Aneurysm cohort was the only cohort analyzed with a hypothesis test, however data was collected similarly for all cohorts and for continued access Subjects. Zone 2 Subjects enrolled for analysis were from the United States only.
Aortic Aneurysm, Thoracic Aorta; Lesion Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Label Type Description Intervention Names Zone 2 Aneurysm Other Includes primary (hypothesis-driven) aneurysm cohort and continued access. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.
Device: GORE® TAG® Thoracic Branch Endoprosthesis Zone 2 Non-aneurysm Other Includes dissection, traumatic transection and other isolated aortic lesion cohorts. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.
Device: GORE® TAG® Thoracic Branch Endoprosthesis
Name Type Description Arm Group Labels Other Names GORE® TAG® Thoracic Branch Endoprosthesis Device Endovascular repair with the TBE Device
Zone 2 Aneurysm Zone 2 Non-aneurysm
Measure Description Time Frame Proportion of Participants With Primary Endpoint Success for Zone 2 Primary Endpoint was composite of the following events: device technical success and absence of aortic rupture, lesion-related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device/procedure/withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
12 Months
Inclusion Criteria:
Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.
Age ≥18 years at time of informed consent signature
Subject is capable of complying with protocol requirements, including follow-up
Informed Consent Form (ICF) is signed by Subject or legal representative
Must have appropriate proximal aortic landing zone.
Must have appropriate target branch vessel landing zone
For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone.
Exclusion Criteria:
Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
Previous endovascular repair of the ascending aorta
Previous endovascular repair of the DTA with a non-Gore device
Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access
Infected aorta
Life expectancy <2 years
Myocardial infarction within 6 weeks prior to treatment
Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin.
Patient has a systemic infection and may be at increased risk of endovascular graft infection
Pregnant female at time of informed consent signature
Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
Participation in another drug or medical device study within one year of study enrollment
Known history of drug abuse within one year of treatment
Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta
Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
Planned coverage of celiac artery
Patient has known sensitivities or allergies to the device materials
Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
Patient with a history of a hypercoagulability disorder and/or hypercoagulability state
Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper
Mycotic aneurysm
Persistent refractory shock (systolic blood pressure <90 mm Hg)
Patient has body habitus or other medical condition which prevents adequate visualization of the aorta
Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis
Accepts Healthy Volunteers No
Name Affiliation Role Michael M Dake, MD Stanford University Principal Investigator Himanshu Patel, MD University of Michigan Principal Investigator
Facility Status City State ZIP Country Contacts Keck Medical Center of USC Los Angeles California 90033 United States Cedar-Sinai Medical Center
PubMed Identifier Type Citation Retractions Derived Squiers JJ, DiMaio JM, Schaffer JM, Baxter RD, Gable CE, Shinn KV, Harrington K, Moore DO, Shutze WP, Brinkman WT, Gable DR. Surgical debranching versus branched endografting in zone 2 thoracic endovascular aortic repair. J Vasc Surg. 2022 Jun;75(6):1829-1836.e3. doi: 10.1016/j.jvs.2021.12.068. Epub 2022 Jan 5.
Available IPD Information Not provided
No data available
No data is available for this block.
ID Title Description FG000 Zone 2 Aneurysm Cohort Aneurysm arm, hypothesis-driven cohort
FG001 Zone 2 Dissection Cohort Non-aneurysm arm, dissection cohort
Title Milestones Reasons Not Completed Overall Study Type Comment Milestone Data STARTED
Baseline Analysis Population Description
No data available
No data is available for this block.
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 Nov 23, 2020 May 18, 2023
No data available
No data is available for this block.
No data available
No data is available for this block.
Non-Randomized
Intervention Model Description Not provided
Leland Stanford Junior University Stanford California 94305-5407 United States
Hartford Hospital Hartford Connecticut 06106 United States
MedStar Health Research Institute Washington D.C. District of Columbia 20010 United States
University of Florida - Gainesville Gainesville Florida 32610 United States
Univeristy of South Florida Tampa Florida 33606 United States
Emory University Atlanta Georgia 30322 United States
Northwestern University Chicago Illinois 60611 United States
St. Vincent Medical Group, Inc. Indianapolis Indiana 46290 United States
University of Louisville Jewish Hospital Louisville Kentucky 40202 United States
University or Maryland Baltimore Baltimore Maryland 21201 United States
Massachusetts General Hospital Boston Massachusetts 02114 United States
University of Michigan Ann Arbor Michigan 48109 United States
Mayo Clinic Rochester Rochester Minnesota 55905 United States
Washington University School of Medicine St Louis Missouri 63110 United States
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03766 United States
Cooper University Hospital Camden New Jersey 08103 United States
Research Foundation SUNY Buffalo Buffalo New York 14203 United States
Carolinas HealthCare Systems Charlotte North Carolina 28203 United States
Duke University Medical Center Durham North Carolina 27710 United States
Cleveland Clinic Cleveland Ohio 44195 United States
Oregon Health & Science University Portland Oregon 97239 United States
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104 United States
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15232 United States
Cardiovascular Surgery Clinic Memphis Tennessee 38120 United States
Vanderbilt University Medical Center Nashville Tennessee 37232 United States
Cardiothoracic and Vascular Surgeons Austin Texas 78756 United States
Baylor College of Medicine - Houston Houston Texas 77030 United States
Houston Methodist Hospital Houston Texas 77030 United States
Memorial Hermann Houston Texas 77030 United States
Heart Hospital at Baylor Plano Plano Texas 75093 United States
Sentara Medical Group Norfolk Virginia 23507 United States
University of Washington Seattle Washington 98195 United States
University of Wisconsin System Madison Wisconsin 53792 United States
FG002 Zone 2 Traumatic Transection Cohort Non-aneurysm arm, traumatic transection cohort
FG003 Zone 2 Other Isolated Lesion Cohort Non-aneurysm arm, other isolated lesion cohort
FG004 Zone 2 Aneurysm Continued Access Aneurysm arm, continued access subjects
FG000 85 subjects One participant (who died and is included in the death count within this section) is excluded from results analysis as pre-specified due to a major I/E violation (i.e. drug abuse), n=84 for analysis.
FG001 136 subjects
FG002 10 subjects One participant excluded from results analysis as pre-specified (i.e. per FDA request for enrollment into the wrong cohort), n=9 for analysis.
FG003 13 subjects
FG004 6 subjects COMPLETED FG000 44 subjects FG001 54 subjects FG002 1 subjects FG003 1 subjects FG004 0 subjects
NOT COMPLETED FG000 41 subjects FG001 82 subjects FG002 9 subjects FG003 12 subjects FG004 6 subjects
Type Comment Reasons Still in study FG000 1 subjects FG001 32 subjects FG002 3 subjects FG003 6 subjects FG004 5 subjects Death FG000 21 subjects FG001 28 subjects FG002 0 subjects FG003 5 subjects FG004 Withdrawal by Subject FG000 8 subjects FG001 4 subjects FG002 1 subjects FG003 1 subjects FG004 Lost to Follow-up FG000 8 subjects FG001 16 subjects FG002 5 subjects FG003 0 subjects FG004 Physician Decision FG000 2 subjects FG001 2 subjects FG002 0 subjects FG003 0 subjects FG004 Discontinued due to Other FG000 1 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects FG004
Two participants (1 Zone 2 Aneurysm and 1 Zone 2 Traumatic Transection) that are counted in the Participant Flow section above are excluded from this analysis, as pre-specified, due to a major I/E violation or an FDA-mandated exclusion.
ID Title Description BG000 Zone 2 Aneurysm Cohort Aneurysm arm, hypothesis-driven cohort
BG001 Zone 2 Dissection Cohort Non-aneurysm arm, dissection cohort
BG002 Zone 2 Traumatic Transection Cohort Non-aneurysm arm, traumatic transection cohort
BG003 Zone 2 Other Isolated Lesion Cohort Non-aneurysm arm, other isolated lesion cohort
BG004 Zone 2 Aneurysm Continued Access Aneurysm arm, continued access subjects
BG005 Total Total of all reporting groups
Units Counts Participants BG000 84 BG001 136 BG002 9 BG003 13 BG004 6 BG005 248
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 Title Measurements BG000 70.3 ± 11.1 BG001 62.7 ± 11.2 BG002 42.4 ± 19.0 BG003
Sex: Female, Male Count of Participants Participants Title Denominators Categories
Ethnicity (NIH/OMB) Count of Participants Participants Title Denominators Categories Title Measurements Hispanic or Latino
Race/Ethnicity, Customized Count of Participants Participants Title Denominators Categories
BMI Mean Standard Deviation kg/(m^2) Title Denominators Categories Title Measurements BG000 28.8 ± 6.3 BG001 30.6 ± 6.5 BG002
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 Proportion of Participants With Primary Endpoint Success for Zone 2 Primary Endpoint was composite of the following events: device technical success and absence of aortic rupture, lesion-related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device/procedure/withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
Two participants (1 Zone 2 Aneurysm and 1 Zone 2 Traumatic Transection) that are counted in the Participant Flow section above are excluded from this analysis, as pre-specified, due to a major I/E violation or an FDA-mandated exclusion.
Primary Endpoint composite denominator was restricted to number of participants either with a primary endpoint event or imaging performed in the 12 Month window.
Posted Number proportion of participants 12 Months ID Title Description OG000 Zone 2 Aneurysm Cohort Aneurysm arm, hypothesis-driven cohort
OG001 Zone 2 Dissection Cohort Non-aneurysm arm, dissection cohort
OG002 Zone 2 Traumatic Transection Cohort Non-aneurysm arm, traumatic transection cohort
OG003 Zone 2 Other Isolated Lesion Cohort Non-aneurysm arm, other isolated lesion cohort
OG004 Zone 2 Aneurysm Continued Access Aneurysm arm, continued access subjects
Units Counts Participants OG000 74 OG001 109 OG002 6 OG003
Title Denominators Categories Title Measurements OG000 0.838 OG001 0.881 OG002 1.0 OG003
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 Primary endpoint success was defined as the proportion of analysis-eligible participants without a primary endpoint event and with 12-Month imaging performed.
Results were tested against a performance goal (PG) of 0.64 (i.e. 64%), derived from historical GORE TAG® and Conformable TAG® data.
Additionally, using a one-sided alpha of 0.05 and Exact Test, minimum power of 80%, the sample needed was 70 patients. With attrition, 85 patients were required.
95% Exact Lower Confidence Limit 0.751 1-Sided Other Performance goal tested using Exact method calculation to estimate the 95% one-sided lower confidence level (95% LCL) on the proportion of participants with primary endpoint success. If the 95% LCL exceeded 0.64, then the the null hypothesis was to be rejected and the PG was met.
Adverse events collected for 60 Months, rates shown are through all reported follow-up, follow-up is ongoing for participants who have not completed the study.
The two excluded participants (1 Zone 2 Aneurysm and 1 Zone 2 Traumatic Transection due to a major I/E violation or an FDA-mandated exclusion) have been included in this Adverse Events section.
Collection starting at endovascular procedure
All-Cause Mortality Comment Not provided
ID Title Description Deaths (Affected) Deaths (At Risk) Serious Events (Affected) Serious Events (At Risk) Other Events (Affected) Other Events (At Risk) EG000 Zone 2 Aneurysm Cohort Aneurysm arm, hypothesis-driven cohort
21 85 61 85 74 85 EG001 Zone 2 Dissection Cohort Non-aneurysm arm, dissection cohort
28 136 99 136 111 136 EG002 Zone 2 Traumatic Transection Cohort Non-aneurysm arm, traumatic transection cohort
0 10 3 10 7 10 EG003 Zone 2 Other Isolated Lesion Cohort Non-aneurysm arm, other isolated lesion cohort
5 13 9 13 11 13 EG004 Zone 2 Aneurysm Continued Access Aneurysm arm, continued access subjects
0 6 4 6 4 6
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Acute anemia Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 0 events 0 affected 13 at risk EG004 0 events 0 affected 6 at risk Acute blood loss anemia Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Anemia Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 4 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Anemia of chronic disease Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Blood loss anemia Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Chemotherapy induced neutropenia Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Coagulopathy Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Disseminated intravascular coagulation Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hemolytic anemia drug-induced Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Heparin-induced thrombocytopenia Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Leukocytosis Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Neutropenic fever Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Normocytic anemia Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Symptomatic anemia Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Thrombocytopenia Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vaso-occlusive crisis Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute heart failure Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute myocardial infarction Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute myocardial infarction type 2 Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute on chronic heart failure Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Aortic valve insufficiency Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Aortic valve stenosis Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Arrhythmia Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Asystole Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Atrial fibrillation Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 5 events 5 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Atrial fibrillation aggravated Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Atrial fibrillation with rapid ventricular response Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Atrial flutter Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Bradycardia Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cardiac arrest Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 9 events 7 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cardiac failure aggravated Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cardiac failure chronic aggravated Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cardiac tamponade Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cardiogenic shock Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Chest pain - cardiac Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Chronic atrial fibrillation Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Chronic diastolic heart failure Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Complete heart block Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Congestive cardiac failure aggravated Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 1 affected 85 at risk EG001 4 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Congestive heart failure Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 6 events 6 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Heart block AV Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Left ventricular systolic dysfunction Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Mitral regurgitation Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Mobitz (type) II atrioventricular block Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Myocardial infarction Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Myocardial ischaemia Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Non ST segment elevation myocardial infarction Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Non-sustained ventricular tachycardia Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Paroxysmal atrial fibrillation Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pericardial effusion Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Persistent atrial fibrillation Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Right coronary artery stenosis Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 ST segment elevation myocardial infarction Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Sick sinus syndrome Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Tachyarrhythmia Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Type II second degree atrioventricular block Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Unstable angina Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Ventricular arrhythmia Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Ventricular fibrillation Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Gastrointestinal arteriovenous malformation Congenital, familial and genetic disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Sickle-cell beta thalassemia Congenital, familial and genetic disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vertigo Ear and labyrinth disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Adrenal mass Endocrine disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Primary hyperthyroidism Endocrine disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cataract (left) Eye disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cataracts Eye disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Detached retina Eye disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Epiretinal membrane Eye disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Retinal detachment Eye disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Sudden visual loss Eye disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vision loss Eye disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Abdominal hematoma Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Abdominal pain Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 3 events 3 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Celiac artery aneurysm Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Celiac artery stenosis Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Colocutaneous fistula Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Colonic polyp Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Constipation Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Crohns disease aggravated Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Diarrhea Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Diverticulosis Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Diverticulum of esophagus, acquired Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Dysphagia Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Gastric ulcer Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Gastroesophageal reflux disease Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Gastrointestinal bleed Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 5 events 4 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Gastrointestinal bleeding Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Gastroparesis Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hiatal hernia Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Ileus Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Incarcerated umbilical hernia Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Inguinal hernia Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Ischemic colitis Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Large intestine perforation Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Left inguinal hernia Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Mesenteric artery stenosis Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Mesenteric ischemia Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Nausea Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Neurogenic bowel Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Partial small intestinal obstruction Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Rectal bleeding Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Retroperitoneal hematoma Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Right inguinal hernia Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Small bowel obstruction Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Upper gastrointestinal bleeding Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Ventral hernia Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vomiting Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Catheter related thrombosis General disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Chest pain (non-cardiac) General disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Continued perfusion of a false lumen General disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Debility General disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Distal aorta false lumen perfusion General disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Distal branch false lumen perfusion General disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Edema lower limb General disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Fever General disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 5 events 5 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Fever of unknown origin General disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Multiple organ failure General disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Non-cardiac chest pain General disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 5 events 5 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Slight fever General disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Stent thrombosis General disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Stent-graft endoleak type IA General disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Stent-graft endoleak type IB General disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Stent-graft endoleak type IC General disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Stent-graft endoleak type II General disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Stent-graft endoleak type III General disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Unilateral leg swelling General disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Unknown cause of death General disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Unspecified chest pain General disorders MedDRA Version 27.0 Systematic Assessment EG000 4 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vascular stent-graft occlusion General disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute cholecystitis Hepatobiliary disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Bile duct obstruction Hepatobiliary disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Biliary colic Hepatobiliary disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Chronic cholecystitis Hepatobiliary disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Gallbladder disorder Hepatobiliary disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hepatic cyst Hepatobiliary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Transaminitis Hepatobiliary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Abscess Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute cystitis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute exacerbation of chronic bronchitis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute pneumonia Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Appendicitis perforated Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Aspiration pneumonia Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Bacteremia Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 COVID-19 Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 COVID-19 pneumonia Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cellulitis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cellulitis of leg Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cellulitis streptococcal Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Clostridium difficile infection Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Colon diverticulitis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Community acquired pneumonia Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Diverticulitis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Diverticulitis intestinal Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Endocarditis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Endocarditis infective Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Gangrene Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 2 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Graft infection Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Groin infection Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Haemophilus parainfluenzae infection Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Healthcare associated pneumonia Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Intra-abdominal abscess Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Klebsiella pneumonia Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Klebsiella septicemia Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Methicillin-resistant Staphylococcus aureus infection Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Methicillin-resistant Staphylococcus aureus sepsis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Mitral valve endocarditis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Neutropenic sepsis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 2 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Osteomyelitis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pericolic abscess Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Peritonitis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pneumonia Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 6 events 6 affected 85 at risk EG001 6 events 5 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pneumonia pseudomonal Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pulmonary sepsis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pyelonephritis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Retroperitoneal abscess Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Sepsis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 7 events 5 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Septic shock Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 4 events 4 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Spinal osteomyelitis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Staphylococcus aureus bacteremia Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Urinary tract infection Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 5 events 4 affected 85 at risk EG001 9 events 6 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Urosepsis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vascular graft infection Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vascular stent graft infection Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Wound infection Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Anastomotic bleeding Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Anemia postoperative Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Aortic pseudoaneurysm Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Arteriovenous fistula thrombosis Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Brain herniation Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Broken leg Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Closed fracture of unspecified part of tibia Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Concussion Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Device placement at incorrect location Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Fall Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Femoral artery pseudoaneurysm Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Femur fracture Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Fracture of intertrochanteric section of femur, closed Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Fractured finger Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Fractured hip Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Fractured ribs Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Great toe fracture Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hemodilution Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hip fracture Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Incision site bleeding Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Intraoperative hemorrhage Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Nephrostomy complication Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Post procedural hematuria Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Post spinal headache Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Postimplantation syndrome Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Postoperative ileus Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Postoperative respiratory failure Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pseudoaneurysm Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Rupture spleen Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Subdural hematoma Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 3 events 3 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Subdural hemorrhage Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Third degree burns Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vascular access site rupture Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vascular pseudoaneurysm Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vertebral fracture Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Red blood cells in cerebrospinal fluid Investigations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Troponin increased Investigations MedDRA Version 27.0 Systematic Assessment EG000 2 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acidosis Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Failure to thrive Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 4 events 3 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Fluid overload Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypercalcemia Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hyperglycemia Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypernatremia Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypoglycemia Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypoglycemia aggravated Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypokalemia Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hyponatremia Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 4 events 4 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hyponatremia aggravated Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypovolemia Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Metabolic acidosis Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Protein-calorie malnutrition Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Type II diabetes mellitus Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Volume overload Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Back pain Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cervical spinal stenosis Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Chest wall hematoma Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Degenerative joint disease Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Degenerative spondylolisthesis Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Interscapular pain Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Knee arthritis Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Low back pain Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Lower extremities weakness of Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Olecranon bursitis Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Osteoarthritis Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Osteoarthritis knee Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pain in thigh Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Rhabdomyolysis Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Rotator cuff tear arthropathy Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Shoulder pain Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Spinal stenosis Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Upper back pain Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Bladder cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Breast cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Ductal carcinoma in situ Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hormone-refractory prostate cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Invasive ductal breast carcinoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Lung cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Lung cancer metastatic Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Lung neoplasm Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Malignant neoplasm of sigmoid colon Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Melanoma Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pancreatic cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Prostate cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Skin cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Small cell lung cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Squamous cell carcinoma of head and neck Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vulvar cancer Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute migraine Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute toxic metabolic encephalopathy Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Anoxic brain damage Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Anoxic encephalopathy Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Anterior spinal artery syndrome Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Aphasia Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Brain compression Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Carotid artery disease Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Carotid artery dissection Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Carotid artery insufficiency Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Carotid artery stenosis Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cerebellar stroke Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cerebral hemorrhage Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cerebral ischemia Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cerebral small vessel ischemic disease Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cerebrovascular accident Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 3 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Convulsive status epilepticus Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Dizziness Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Embolic stroke Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Encephalopathy Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Encephalopathy acute Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Headache Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hemorrhagic stroke Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hydrocephalus Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Intracerebral hematoma Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Intracerebral hemorrhage Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Intraparenchymal cerebral hemorrhage Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Intraventricular hemorrhage Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Ischemic stroke Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Metabolic encephalopathy Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Near syncope Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Neuropathy peripheral Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Nonconvulsive status epilepticus Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Numbness in hand Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Paralysis leg Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Paraplegia Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Seizure Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Spinal cord infarction Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Spinal cord ischemia Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Stroke Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 3 events 3 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Stroke syndrome Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Stupor Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Subarachnoid hemorrhage Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Syncopal attack Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Syncope Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Tonic-clonic seizures Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Transient global amnesia Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Transient ischemic attack Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vocal cord paralysis Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Device dislodgement Product Issues MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Device lead fracture Product Issues MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Alcohol withdrawal syndrome Psychiatric disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Confusion Psychiatric disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Conversion disorder Psychiatric disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Delirium Psychiatric disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Intensive care unit delirium Psychiatric disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Mental status changes Psychiatric disorders MedDRA Version 27.0 Systematic Assessment EG000 3 events 2 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute kidney injury Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 8 events 8 affected 85 at risk EG001 7 events 6 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute renal failure Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute renal insufficiency Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute tubular necrosis Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Chronic kidney disease stage 3 Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Kidney atrophic Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Kidney stones Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Nephrolithiasis Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Nephropathy Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Nephrotic syndrome Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Neurogenic bladder Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Renal artery stenosis Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Renal calculi Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Renal failure Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Renal failure aggravated Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Renal hematoma Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Renal mass Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Stone urinary bladder Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Ureter obstruction Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Ureteral calculus Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Urethral stricture Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Urinary retention Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Benign prostatic hyperplasia Reproductive system and breast disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Benign prostatic hypertrophy Reproductive system and breast disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pelvic floor dysfunction Reproductive system and breast disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Rectocele Reproductive system and breast disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Uterovaginal prolapse Reproductive system and breast disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vaginal bleeding Reproductive system and breast disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute hypoxic respiratory failure Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute pulmonary edema Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute respiratory distress syndrome Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Acute respiratory failure Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute respiratory insufficiency Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Chronic obstructive pulmonary disease Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Chronic respiratory failure Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cough Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Deviated nasal septum Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Dyspnea Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Dyspnea exacerbated Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Epistaxis Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Flash pulmonary edema Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hemoptysis Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hemothorax Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Hypercapnic respiratory failure Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 4 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypercarbia Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypoxemia Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypoxia Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypoxic respiratory failure Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 5 events 5 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pleural effusion Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Pneumothorax Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pulmonary edema Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pulmonary embolism Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Respiratory distress Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Respiratory failure Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Respiratory insufficiency Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Shortness of breath Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Decubitus Skin and subcutaneous tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Decubitus ulcer Skin and subcutaneous tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Ecchymosis Skin and subcutaneous tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pressure ulcer Skin and subcutaneous tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Abdominal aortic aneurysm Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Abdominal aortic aneurysm enlargement Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Accelerated hypertension Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute hemorrhage Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute limb ischemia Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Aneurysm enlargement Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Aortic aneurysm Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Aortic aneurysm enlargement Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Aortic aneurysm rupture Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Aortic dissection Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Aortic dissection rupture Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Aortic intramural hematoma Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Aortic rupture Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Arterial hemorrhage Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Arterial rupture Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Arteriovenous fistula Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Ascending aortic dissection Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Atherosclerotic cardiovascular disease Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Deep vein thrombosis Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Deep vein thrombosis leg Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Deep venous thrombosis arm Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Dissecting aortic aneurysm Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Embolism limb Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Femoral artery dissection Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Groin haematoma Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Groin hematoma Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hematoma Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hemodynamic instability Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hemorrhagic shock Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypertension Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypertension worsened Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypertensive crisis Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypertensive emergency Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypertensive urgency Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypotension Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 4 events 4 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Iliac artery aneurysm enlargement Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Iliac artery dissection Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Iliac artery occlusion Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Iliac artery rupture Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 4 events 3 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Iliofemoral artery thrombosis Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Inferior vena cava stenosis Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Orthostatic hypotension Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Peripheral artery dissection Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Popliteal artery aneurysm Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Retrograde aortic dissection Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Shock, unspecified Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Subclavian artery stenosis Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Subclavian steal syndrome Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Thoracic aortic aneurysm Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Thoracic aortic aneurysm enlargement Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Thoracoabdominal aortic aneurysm Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Thoracoabdominal aortic aneurysm enlargement Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Thromboembolism Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Type A aortic dissection Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Type B aortic dissection Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 1 affected 85 at risk EG001 3 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Uncontrolled hypertension Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Venous stasis Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Anemia Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 5 events 5 affected 85 at risk EG001 7 events 7 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 0 events 0 affected 13 at risk EG004 0 events 0 affected 6 at risk Blood loss anemia Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypercoagulability Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Hypercoagulation Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Leukocytosis Blood and lymphatic system disorders MedDRA Version 27.0 Systematic Assessment EG000 5 events 5 affected 85 at risk EG001 5 events 5 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Atrial fibrillation Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 7 events 7 affected 85 at risk EG001 6 events 6 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Long QT syndrome Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Non ST segment elevation myocardial infarction Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Tachycardia Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 2 events 2 affected 10 at risk EG003 Tricuspid regurgitation Cardiac disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Blurry vision Eye disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Diplopia Eye disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Abdominal pain Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acid reflux (esophageal) Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Constipation Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 4 events 4 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Epigastric pain Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 4 events 4 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Gastrointestinal bleed Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hiatal hernia Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Mesenteric edema Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Retroperitoneal hematoma Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 5 events 5 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Stomach pain Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Superior mesenteric artery syndrome Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Upper abdominal pain Gastrointestinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Arterial stent occlusion General disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Edema of lower extremities General disorders MedDRA Version 27.0 Systematic Assessment EG000 5 events 5 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Fever General disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 9 events 9 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Low grade fever General disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Non-cardiac chest pain General disorders MedDRA Version 27.0 Systematic Assessment EG000 10 events 9 affected 85 at risk EG001 10 events 8 affected 136 at risk EG002 2 events 2 affected 10 at risk EG003 Stent-graft endoleak type IA General disorders MedDRA Version 27.0 Systematic Assessment EG000 7 events 6 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Stent-graft endoleak type II General disorders MedDRA Version 27.0 Systematic Assessment EG000 11 events 10 affected 85 at risk EG001 5 events 5 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Substernal pain General disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Unilateral leg swelling General disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Vascular stent-graft thrombosis General disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Weakness generalized General disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cholecystitis Hepatobiliary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Acute bronchitis Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 COVID-19 Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 7 events 7 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cellulitis of leg Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Influenza Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pneumonia Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 4 events 2 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Upper respiratory infection Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Urinary tract infection Infections and infestations MedDRA Version 27.0 Systematic Assessment EG000 6 events 5 affected 85 at risk EG001 8 events 7 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Fall Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 7 events 7 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Incision site hematoma Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Incision site pain Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Postoperative pain Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 6 events 5 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Tick bite Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Wrist injury Injury, poisoning and procedural complications MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Weight loss Investigations MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Appetite lost Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hyperkalemia Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Volume overload Metabolism and nutrition disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Back pain Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 4 events 4 affected 85 at risk EG001 8 events 8 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Lower extremities weakness of Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 4 events 3 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Lumbar pain Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Neck pain Musculoskeletal and connective tissue disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Dementia Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Encephalopathy acute Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Headache Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 6 events 6 affected 85 at risk EG001 3 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Neuralgia Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Numbness in feet Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Numbness in fingers Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Numbness in leg Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Numbness of upper arm Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Numbness of upper extremities Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Paresthesia lower limb Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Presyncope Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Tingling of extremity Nervous system disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pre-eclampsia Pregnancy, puerperium and perinatal conditions MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Anxiety Psychiatric disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Anxiety disorder Psychiatric disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Delirium Psychiatric disorders MedDRA Version 27.0 Systematic Assessment EG000 5 events 5 affected 85 at risk EG001 4 events 4 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Major depression Psychiatric disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Acute kidney injury Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 3 events 3 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Acute tubular necrosis Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Chronic kidney disease stage 3 Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hematuria Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Oliguria Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Renal infarction Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Ureteral calculus Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Urinary retention Renal and urinary disorders MedDRA Version 27.0 Systematic Assessment EG000 6 events 6 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Atelectasis Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 6 events 5 affected 85 at risk EG001 4 events 4 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Bilateral pleural effusion Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 4 events 4 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Chronic obstructive pulmonary disease exacerbation Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Cough Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 3 events 3 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Epistaxis Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Exercise dyspnea Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Lung nodule Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 2 events 2 affected 85 at risk EG001 7 events 6 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pleural effusion Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 1 events 1 affected 85 at risk EG001 8 events 8 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pleuritic pain Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Pulmonary collapse Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Respiratory distress Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003 Shortness of breath Respiratory, thoracic and mediastinal disorders MedDRA Version 27.0 Systematic Assessment EG000 5 events 5 affected 85 at risk EG001 7 events 7 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Artery dissection Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 1 events 1 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Ascending aortic aneurysm enlargement Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypertension Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 6 events 5 affected 85 at risk EG001 5 events 5 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypotension Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 8 events 6 affected 85 at risk EG001 5 events 4 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Hypotension symptomatic Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Iliac artery dissection Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 4 events 4 affected 85 at risk EG001 2 events 2 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Penetrating atherosclerotic ulcer Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 0 events 0 affected 10 at risk EG003 Subclavian artery occlusion Vascular disorders MedDRA Version 27.0 Systematic Assessment EG000 0 events 0 affected 85 at risk EG001 0 events 0 affected 136 at risk EG002 1 events 1 affected 10 at risk EG003
Are all PI(s) employees of the sponsor? No
Results Disclosure Restriction on PI(s)? No
Title Organization Phone Extension Email Meier Hsu W.L. Gore 928-864-3338 mhsu@wlgore.com
SAP No Yes No Statistical Analysis Plan Mar 19, 2021 Apr 25, 2023
ID Term D017545 Aortic Aneurysm, Thoracic
ID Term D001014 Aortic Aneurysm D000783 Aneurysm D014652 Vascular Diseases D002318 Cardiovascular Diseases D001018 Aortic Diseases
0 subjects
0 subjects
1 subjects
0 subjects
0 subjects
64.8
± 13.3
BG004 59.8 ± 15.9
BG005 64.5 ± 12.9 1
BG003 7
BG004 3
BG005 75 Male BG000 53 BG001 103 BG002 8 BG003 6 BG004 3 BG005 173
4
BG003 3
BG004 0
BG005 16 Not Hispanic or Latino BG000 82 BG001 127 BG002 5 BG003 10 BG004 6 BG005 230
Unknown or Not Reported BG000 0 BG001 2 BG002 0 BG003 0 BG004 0 BG005 2
5
BG003 9
BG004 5
BG005 185 Black or African American BG000 12 BG001 29 BG002 0 BG003 2 BG004 1 BG005 44
Asian BG000 3 BG001 3 BG002 0 BG003 0 BG004 0 BG005 6
American Indian or Alaska Native BG000 0 BG001 1 BG002 0 BG003 0 BG004 0 BG005 1
Hawaiian or Pacific Islander BG000 1 BG001 1 BG002 0 BG003 0 BG004 0 BG005 2
Other BG000 1 BG001 3 BG002 4 BG003 2 BG004 0 BG005 10
Unknown or Not Reported BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0
29.5
± 5.0
BG003 25.8 ± 5.3
BG004 36.3 ± 8.3
BG005 29.8 ± 6.5 8
OG004 6 0.875
OG004 1.0 0 events
0 affected
13 at risk
EG004 1 events 1 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 1 events 1 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
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0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
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13 at risk
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13 at risk
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13 at risk
EG004 1 events 1 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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1 affected
13 at risk
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0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 2 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
0 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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1 affected
13 at risk
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13 at risk
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
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1 affected
13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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13 at risk
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1 affected
13 at risk
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1 affected
13 at risk
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1 affected
13 at risk
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13 at risk
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1 affected
13 at risk
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
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13 at risk
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1 affected
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1 affected
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13 at risk
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1 affected
13 at risk
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1 affected
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13 at risk
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13 at risk
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1 affected
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1 affected
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13 at risk
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1 affected
13 at risk
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 0 events
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13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
13 at risk
EG004 0 events 0 affected 6 at risk 1 events
1 affected
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