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Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Treatment with the Edwards PASCAL Transcatheter Valve Repair System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards PASCAL Transcatheter Valve Repair System | Device | Repair of the tricuspid valve through a transcatheter approach |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite Major Adverse Event (MAE) Rate | Number and percentage of patients who experienced at least one major adverse event (MAE). Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction (MI), stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency re-intervention related to the device, and major access site and vascular complications requiring intervention at 30 days. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | Number and percentage of Device Success, definition modified from MVARC criteria. Per device analysis | Intraprocedural |
| Procedural Success | Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susheel K. Kodali, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Emory University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37137586 | Derived | Kodali SK, Hahn RT, Davidson CJ, Narang A, Greenbaum A, Gleason P, Kapadia S, Miyasaka R, Zahr F, Chadderdon S, Smith RL, Grayburn P, Kipperman RM, Marcoff L, Whisenant B, Gonzales M, Makkar R, Makar M, O'Neill W, Wang DD, Gray WA, Abramson S, Hermiller J, Mitchel L, Lim DS, Fowler D, Williams M, Pislaru SV, Dahou A, Mack MJ, Leon MB, Eleid MF. 1-Year Outcomes of Transcatheter Tricuspid Valve Repair. J Am Coll Cardiol. 2023 May 9;81(18):1766-1776. doi: 10.1016/j.jacc.2023.02.049. | |
| 33509390 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Edwards PASCAL Transcatheter Tricuspid Valve Repair System | Tricuspid valve repair with PASCAL implanted via transcatheter procedure |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| At 30 Days Follow-up |
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| At 6 Months Follow-up |
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| At 1 Year Follow-up |
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| At 2 Years Follow-up |
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| At 3 Years Follow-up |
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| At 4 Years Follow-up |
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| At 5 Years Follow-up |
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Intent-to-treat population: All randomized participants who received any amount of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Edwards PASCAL Transcatheter Tricuspid Valve Repair System | Tricuspid valve repair with PASCAL implanted via transcatheter procedure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Major Adverse Event (MAE) Rate | Number and percentage of patients who experienced at least one major adverse event (MAE). Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction (MI), stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency re-intervention related to the device, and major access site and vascular complications requiring intervention at 30 days. | Posted | Count of Participants | Participants | 30 days |
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Up to 5 Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Edwards PASCAL Transcatheter Valve Repair System | Repair of the tricuspid valve through a transcatheter approach |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tricuspid Valve Incompetence | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ted Feldman | Edwards Lifesciences | 949-250-2500 | Feldman_Info@edwards.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 12, 2019 | Sep 30, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2019 | Sep 30, 2024 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D015154 | Esophageal Motility Disorders |
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| Discharge (2-7 days) |
| Clinical Success | Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis | 30 days |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| St. Vincent Heart Center of Indiana | Indianapolis | Indiana | 46290 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Columbia University Medical Center/New York Presbyterian Hospital | New York | New York | 10032 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Derived |
| Kodali S, Hahn RT, Eleid MF, Kipperman R, Smith R, Lim DS, Gray WA, Narang A, Pislaru SV, Koulogiannis K, Grayburn P, Fowler D, Hawthorne K, Dahou A, Deo SH, Vandrangi P, Deuschl F, Mack MJ, Leon MB, Feldman T, Davidson CJ; CLASP TR EFS Investigators. Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2021 Feb 2;77(4):345-356. doi: 10.1016/j.jacc.2020.11.047. |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index | Data unavailable for 2 patients. | Mean | Standard Deviation | Kilogram Per Square Meter |
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| Tobacco Use | Count of Participants | Participants |
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| NYHA Class | NYHA Classification - The stages of heart failure: 1. Class I - No symptoms and no limitation in ordinary physical activity. 2. Class II - Mild symptoms and slight limitation during ordinary activity. 3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. 4. Class IV - Severe limitations. Experiences symptoms even while at rest. | Count of Participants | Participants |
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| EuroScore II | The European System for Cardiac Operative Risk Evaluation (EuroSCORE) II is a risk model which allows the calculation of the risk of death after a heart operation with a range of 0-100%. The higher the score, the higher the risk of an adverse outcome EuroScore II risk levels are as follows: Low risk: <8 Moderate risk: 8-10 High risk: >10 | Data unavailable for 5 patients. | Mean | Standard Deviation | % |
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| STS Mortality Score (MV Repair) | The STS score is a validated risk-prediction model for open surgery based on data from the STS National Adult Cardiac Surgery Database with a range of 0-100%. An STS predicted risk of surgical mortality of 4%-8% is considered intermediate risk and 8% or greater is considered high risk. As of November 15, 2018, The Society of Thoracic Surgeons released an updated short-term risk calculator to reflect the latest 2018 adult cardiac surgery risk models. The STS Calculator allows you to calculate a patient's risk of mortality and morbidities for the most commonly performed cardiac surgeries. | Data unavailable for 3 patients. | Mean | Standard Deviation | % |
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| Clinical Frailty Total Score | Data unavailable for 2 patients. | Count of Participants | Participants |
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| Katz Activities of Daily Living Total Score | The Katz Index of Independence in Activities of Daily Living (ADL) uses a scoring range from 0 (completely dependent) to 6 (completely independent). | Data unavailable for 2 patients. | Mean | Standard Deviation | Unit on a scale |
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| Modified Rankin Scale | Data unavailable for 59 patients. | Count of Participants | Participants |
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| Participants |
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| Secondary | Device Success | Number and percentage of Device Success, definition modified from MVARC criteria. Per device analysis | Per device analysis | Posted | Count of Units | Device | Intraprocedural | Device | Device |
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| Secondary | Procedural Success | Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis | The outcome is reported where data is available. | Posted | Count of Participants | Participants | Discharge (2-7 days) |
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| Secondary | Clinical Success | Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis | The outcome is reported where data is available. | Posted | Count of Participants | Participants | 30 days |
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| 29 |
| 65 |
| 56 |
| 65 |
| 59 |
| 65 |
| Atrial Fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Tricuspid Valve Incompetence | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vascular Disorders | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Cardiac Failure Acute | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Blood and Lymphatic System Disorders | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Cardiac Disorder | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Gastric Disorders | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| General Disorders and Administration Site Conditions | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Infections and Infestations | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
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| Nervous System Disorders | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Renal and Urinary Disorders | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Respiratory, Thoracic and Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Cardiac Failure Acute | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Vascular Access Site Haemorrhage | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Investigations | Investigations | MedDRA (Unspecified) | Systematic Assessment |
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| Psychiatric Disorders | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Surgical and Medical Procedures | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Blood and Lymphatic System Disorders | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Cardiac Disorders | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| General Disorders and Administration Site Conditions | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hepatobiliary Disorders | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Infections and Infestations | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Injury, Poisoning and Procedural Complications | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Metabolism and Nutrition Disorders | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
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| Nervous System Disorders | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Renal and Urinary Disorders | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Respiratory, Thoracic and Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vascular Disorders | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |