Observational Study to Evaluate PAD Treatment Clinical an... | NCT01855412 | Trialant
NCT01855412
Sponsor
Abbott Medical Devices
Status
Completed
Last Update Posted
Jul 18, 2023Actual
Enrollment
1,204Actual
Phase
Not provided
Conditions
Peripheral Arterial Occlusive Disease
Interventions
PAD endovascular treatments
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01855412
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CLN-0001-P
Secondary IDs
Not provided
Brief Title
Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes
Official Title
LIBERTY 360: Prospective, Observational, Multi-Center Clinical Study to Evaluate Acute and Long Term Clinical and Economic Outcomes of Endovascular Device Intervention in Patients With Distal Outflow Peripheral Arterial Disease (PAD)
Acronym
LIBERTY
Organization
Abbott Medical DevicesINDUSTRY
Status Module
Record Verification Date
Jul 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2013
Primary Completion Date
Apr 11, 2019Actual
Completion Date
Apr 11, 2019Actual
First Submitted Date
May 7, 2013
First Submission Date that Met QC Criteria
May 13, 2013
First Posted Date
May 16, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 12, 2021
Results First Submitted that Met QC Criteria
Apr 28, 2021
Results First Posted Date
May 18, 2021Actual
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
Jul 14, 2023
Last Update Posted Date
Jul 18, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Abbott Medical DevicesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate acute and long term clinical and economic outcomes of endovascular procedures to treat Peripheral Arterial Disease (PAD).
Detailed Description
This is a prospective, observational, multi-center, clinical study examining predictors of clinical outcomes for patients undergoing endovascular treatment of lesions within or extending into the target area (10 cm above the medial epicondyle to the digital arteries). This includes disease in a vessel located within or extending into the distal superficial femoral artery (SFA), popliteal (POP), tibial peroneal trunk (TPT), anterior tibial (AT), posterior tibial (PT), and peroneal tibial (PR) arteries.
Conditions Module
Conditions
Peripheral Arterial Occlusive Disease
Keywords
PAD
LIBERTY
Observational
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
No
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
1,204Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Claudication (Rutherford 2-3)
Patients who have been diagnosed with PAD and are classified as on the Rutherford Scale as Rutherford 2-3. Patients may be treated with any FDA-cleared endovascular PAD treatment.
Other: PAD endovascular treatments
CLI Rutherford 4-5
Patients who have been diagnosed with PAD and classified on the Rutherford Scale as Rutherford 4-5. Patients may be treated with any FDA-cleared endovascular PAD treatment.
Other: PAD endovascular treatments
CLI Rutherford 6
Patients who have been diagnosed with PAD and classified on the Rutherford Scale as Rutherford 6. Patients may be treated with any FDA-cleared endovascular PAD treatment.
Other: PAD endovascular treatments
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PAD endovascular treatments
Other
All FDA-cleared endovascular PAD treatments
CLI Rutherford 4-5
CLI Rutherford 6
Claudication (Rutherford 2-3)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Procedural Success of Endovascular PAD Treatment(s)
Final post-procedural result of <50% residual stenosis for all treated lesions for a participant during index procedure and without angiographic complications as determined by the Angiographic Core Laboratory.
Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Lesion Success of Endovascular PAD Treatment(s)
Final post-procedural result of <50% residual stenosis for a given lesion treated during index procedure without angiographic complications as determined by the Angiographic Core Laboratory.
Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years
A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event through 1 year and 3 years.
1- and 3-year MAE is composed of:
Death within 30 days of index procedure
Unplanned major (above the ankle) amputation of the target limb
Clinically-driven TVR (Target Vessel Revascularization) of the target limb
One (1) year and three (3) years post-procedure
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subject's age ≥ 18 years.
Subject presents with a Rutherford classification of 2 to 6.
Subject presents with clinical evidence of PAD requiring endovascular intervention on one or both limbs that includes a target lesion in a native vessel located within or extending into 10 cm above the medial epicondyle to the digital arteries.
If subject presents with bilateral disease, the first limb treated with a lesion in the target area will be considered the target limb.
For subjects with one or more wounds on the target limb, the target lesion(s) should be considered the lesion(s) in the vessel(s) that provide(s) blood flow to the wound(s).
Subject has at least one lesion in a native vessel located within or extending into the target area that is crossed and treated with an endovascular device.
Exclusion Criteria:
Subject is unwilling or unable to sign the IRB-approved informed consent form (ICF).
Subject is unable to understand or comply with the study protocol requirements.
Subject is currently participating in an investigational drug or other device study that can clinically interfere with the endpoints of this study.
Subject requires a conversion from endovascular intervention to a surgical bypass graft for any lesion(s) in the target area, as determined by the Investigator.
Subject has an in-stent restenosis in the target area, and this lesion is the only one requiring treatment.
Subject is pregnant or planning to become pregnant within the study period.
Subject has an anticipated life span of less than one (1) year.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Patients who have been determined by their physician to require endovascular device treatment for their PAD.
Adams GL, Mustapha J, Gray W, Hargus NJ, Martinsen BJ, Ansel G, Jaff MR. The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease. Am Heart J. 2016 Apr;174:14-21. doi: 10.1016/j.ahj.2015.12.013. Epub 2015 Dec 30.
Giannopoulos S, Shammas NW, Cawich I, Staniloae CS, Adams GL, Armstrong EJ. Sex-Related Differences in the Outcomes of Endovascular Interventions for Chronic Limb-Threatening Ischemia: Results from the LIBERTY 360 Study. Vasc Health Risk Manag. 2020 Jul 8;16:271-284. doi: 10.2147/VHRM.S246528. eCollection 2020.
Giannopoulos S, Pliagas G, Armstrong EJ. Procedural and 3-Year Outcomes of Peripheral Vascular Interventions Performed in Office-Based Labs: LIBERTY 360 Sub-Analysis. J Invasive Cardiol. 2021 May;33(5):E365-E377. doi: 10.25270/jic/20.00594.
Result
Giannopoulos, S, Fakorede FA, Cawich I, Dishmon D, Horne A, Raja ML, Mustapha JA, Adams GL, Armstrong EJ. Racial Disparities in Risk for Major Amputation or Death After Endovascular Interventions for Peripheral Artery Disease: A LIBERTY 360 Study. J Crit Limb Ischemia. 2021 June;1(2):E62-E72.
Metser G, Puma J, Mustapha J, Adams GL, Ratcliffe J, Khullar P, Rosero JHC, Armstrong EJ, Zayed M, Green P. Clinical Outcomes of Additional Below-The-Ankle Intervention Compared to Below-The-Knee Intervention Alone: A Post-Hoc Analysis of a Prospective Multicenter Study. J Endovasc Ther. 2023 Oct;30(5):711-720. doi: 10.1177/15266028221092981. Epub 2022 May 3.
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
FG002
CLI Rutherford 6
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
FG000501 subjects
FG001603 subjects
FG002100 subjects
COMPLETED
FG000289 subjects
FG001260 subjects
FG00224 subjects
NOT COMPLETED
FG000212 subjects
FG001343 subjects
FG00276 subjects
Type
Comment
Reasons
Death
FG00077 subjects
FG001123 subjects
FG00230 subjects
Lost to Follow-up
FG00028 subjects
FG00146 subjects
FG00215 subjects
Withdrawal by Subject
FG00077 subjects
FG001123 subjects
FG00224 subjects
Physician Decision
FG00025 subjects
FG00131 subjects
FG0023 subjects
Site Closure
FG0004 subjects
FG00118 subjects
FG0021 subjects
Reason not Specified
FG0001 subjects
FG0012 subjects
FG0023 subjects
Baseline analysis population consists of data from 1,189 enrolled subjects with Investigator signed baseline and procedure patient records. Due to site closure and lack of Investigator signature, 15 subjects were excluded from the cohort.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Claudication (Rutherford 2-3)
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
BG001
CLI Rutherford 4-5
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
BG002
CLI Rutherford 6
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000500
BG001589
BG002100
BG0031189
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Age was not collected for one subject in the CLI Rutherford 6 group.
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000500
ParticipantsBG001589
ParticipantsBG00299
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000500
ParticipantsBG001589
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000500
ParticipantsBG001589
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Caucasian
ParticipantsBG000500
ParticipantsBG001589
ParticipantsBG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
ParticipantsBG000500
ParticipantsBG001589
ParticipantsBG002
Baseline Rutherford Classification (RC)
Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD.
There are seven Rutherford categories used to grade the severity of peripheral artery disease; 0: asymptomatic, 1: mild claudication, 2: moderate claudication, 3: severe claudication, 4: ischemic rest pain, 5: minor tissue loss, 6: major tissue loss.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000500
ParticipantsBG001589
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
Procedural Success of Endovascular PAD Treatment(s)
Final post-procedural result of <50% residual stenosis for all treated lesions for a participant during index procedure and without angiographic complications as determined by the Angiographic Core Laboratory.
Analysis population consists of data from 1,106 enrolled subjects with sufficient information to assess procedural success. Fifteen subjects were excluded due to site closure and lack of investigator signature, 83 subjects were excluded due to lack of sufficient stenosis and/or angiographic complication data to determine success or failure.
Posted
Number
95% Confidence Interval
percent of procedures
Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
ID
Title
Description
OG000
Claudication (Rutherford 2-3)
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
OG001
CLI Rutherford 4-5
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
OG002
CLI Rutherford 6
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Units
Counts
Participants
OG000469
OG001545
OG00292
Title
Denominators
Categories
Title
Measurements
OG00083.6(79.9 to 86.8)
OG00175.8(72.0 to 79.3)
OG00268.5(58.0 to 77.8)
Primary
Lesion Success of Endovascular PAD Treatment(s)
Final post-procedural result of <50% residual stenosis for a given lesion treated during index procedure without angiographic complications as determined by the Angiographic Core Laboratory.
Analysis population consists of data from 1,452 treated lesions with sufficient information to assess procedural success. Data from fifteen subjects were excluded due to site closure and lack of investigator signature; 76 lesions were excluded due to lack of sufficient stenosis and/or angiographic complication data to determine success or failure.
Posted
Number
95% Confidence Interval
percent of lesions treated
Participants were followed from baseline procedure through hospital discharge, an expected average of less than 24 hours
ID
Title
Description
OG000
Claudication (Rutherford 2-3)
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
OG001
CLI Rutherford 4-5
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
OG002
Primary
Rate of Freedom From Major Adverse Events (MAEs) at One (1) and Three (3) Years
A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event through 1 year and 3 years.
1- and 3-year MAE is composed of:
Death within 30 days of index procedure
Unplanned major (above the ankle) amputation of the target limb
Clinically-driven TVR (Target Vessel Revascularization) of the target limb
Analysis population consists of data from 1,189 enrolled subjects with Investigator signed baseline and procedure patient records. Due to site closure and lack of Investigator signature, 15 subjects were excluded in the cohort.
Posted
Number
95% Confidence Interval
percent probability of freedom from MAE
One (1) year and three (3) years post-procedure
ID
Title
Description
OG000
Claudication (Rutherford 2-3)
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
OG001
CLI Rutherford 4-5
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Time Frame
Index procedure through 5 years
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Claudication Rutherford 2-3 Procedure Through 30 Days
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
2
501
72
501
28
501
EG001
CLI Rutherford 4-5 Procedure Through 30 Days
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
2
603
112
603
31
603
EG002
CLI Rutherford 6 Procedure Through 30 Days
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
4
100
24
100
2
100
EG003
Rutherford 2-3 31 Days - 365 Days Post-Procedure
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 31 Days - 365 Days Post-Procedure
18
501
145
501
0
501
EG004
CLI Rutherford 4-5 31 Days - 365 Days Post-Procedure
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 31 Days - 365 Days Post-Procedure
40
603
249
603
0
603
EG005
CLI Rutherford 6 31 Days - 365 Days Post-Procedure
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 31 Days - 365 Days Post-Procedure
17
100
40
100
0
100
EG006
Claudication Rutherford 2-3 366 Days Post-Procedure or Greater
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 2-3.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 366 Days Post-Procedure or Greater
57
501
167
501
0
501
EG007
CLI Rutherford 4-5 366 Days Post-Procedure or Greater
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 4-5.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 366 Days Post-Procedure or Greater
81
603
227
603
0
603
EG008
CLI Rutherford 6 366 Days Post-Procedure or Greater
Patients who have been diagnosed with PAD and are classified on the Rutherford Scale as Rutherford 6.
PAD endovascular treatments: Patients may be treated with any approved or cleared FDA endovascular devices, per physician choice.
Adverse events occurring between 366 Days Post-Procedure or Greater
9
100
24
100
0
100
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arrhythmias
Cardiac disorders
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected603 at risk
EG0021 events1 affected100 at risk
EG0030 events0 affected501 at risk
EG0041 events1 affected603 at risk
EG0050 events0 affected100 at risk
EG0061 events1 affected501 at risk
EG0072 events2 affected603 at risk
EG0080 events0 affected100 at risk
Cardiac dysfunction - Chronic heart failure or aggravated
Cardiac disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0021 events1 affected100 at risk
EG003
Cardiac/cardiopulmonary arrest
Cardiac disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0023 events3 affected100 at risk
EG003
Cardiomyopathy
Cardiac disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Coronary artery disease
Cardiac disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Coronary artery thrombus/thrombosis
Cardiac disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Myocardial infarction
Cardiac disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0016 events6 affected603 at risk
EG0021 events1 affected100 at risk
EG003
Other cardiac
Cardiac disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Gastrointestional infection/inflammation
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Other digestive disorders
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Allergic reaction
General disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Blood and lymphatic system disorder-anemia
General disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0011 events1 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Cancer
General disorders
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Compartment syndrome
General disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Death-unknown cause
General disorders
Systematic Assessment
EG0001 events1 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Infection-Systemic
General disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Injury/trauma
General disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Multi-organ failure
General disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Other adverse event
General disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Shock
General disorders
Systematic Assessment
EG0000 events0 affected501 at risk
EG0010 events0 affected603 at risk
EG0020 events0 affected100 at risk
EG003
Hepatic-biliary system disorders (e.g. liver, bile duct)