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This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARRESTâ„¢ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVARRESTâ„¢ | Experimental | EVARRESTâ„¢ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). |
|
| Topical hemostat | Active Comparator | Equine collagen with Human Fibrinogen and Human Thrombin |
|
| Standard of Care | Active Comparator | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVARRESTâ„¢ | Biological | EVARRESTâ„¢ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. | Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closur | Intraoperative, 3 minutes following treatment application |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application | The number of subjects achieving hemostatic success at 6 minutes following treatment application. | Intraoperative, 6 minutes following treatment application |
| Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerome Riebman, MD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Site #5 | Indianapolis | Indiana | 46260 | United States | ||
| Clinical Investigation Site #6 |
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Subjects were recruited from September 17, 2012 through September 3, 2013 at hospitals and medical centers throughout the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | EVARREST Fibrin Sealant Patch | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. |
| FG001 | Topical Hemostat | Equine collagen sponge with Human Fibrinogen and Human Thrombin |
| FG002 | Standard of Care (SoC) | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline data was summarized for Intent to Treat (ITT) Set, which included all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | EVARREST Fibrin Sealant Patch | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. |
| BG001 | Topical Hemostat |
| 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 | Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. | Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closur | Posted | Count of Participants | Participants | Intraoperative, 3 minutes following treatment application |
|
From surgical procedure through the 30 day follow-up (+/- 14 days)
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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 | EVARREST Fibrin Sealant Patch | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPOTENSION | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Kocharian, MD, PhD | Ethicon, Inc | +1-908-218-2013 | rkochar1@its.jnj.com |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Topical hemostat | Biological | Equine collagen with Human Fibrinogen and Human Thrombin |
|
| Standard of Care | Other | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. |
|
Number of subjects achieving hemostatic success at 10 minutes following treatment application. |
| Intraoperative, 10 minutes following treatment application |
| Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment | The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had re-bleeding requiring treatment | Intra-operative, prior initiation of final chest wall closure. Safety Issue: |
| Number of Participants With Adverse Events Potentially Related to Thrombotic Events | The number of subjects with an adverse event potentially related to a thrombotic event | 30 days (+ 14 days) following surgery |
| Kansas City |
| Missouri |
| 64111 |
| United States |
| Clinical Investigation Site #4 | Camden | New Jersey | 08103 | United States |
| Clinical Investigation Site #1 | Paterson | New Jersey | 07503 | United States |
| Clinical Investigation Site #3 | New York | New York | 10016 | United States |
| Clinical Investigation Site #2 | New York | New York | 10075 | United States |
Equine collagen sponge with Human Fibrinogen and Human Thrombin |
| BG002 | Standard of Care (SoC) | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| BMI Category | Underweight: < 18.5 kg/m^2, Normal weight: 18.5 - <25 kg/m^2 , Overweight: 25 - <30 kg/m^2, Obese: 30 - <40 kg/m^2, Morbidly obese: 40 kg/m^2 or more | Number | Participant |
|
Equine collagen sponge with Human Fibrinogen and Human Thrombin
| OG002 | Standard of Care (SoC) | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. |
|
|
|
| Secondary | Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application | The number of subjects achieving hemostatic success at 6 minutes following treatment application. | Posted | Count of Participants | Participants | Intraoperative, 6 minutes following treatment application |
|
|
|
| Secondary | Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application | Number of subjects achieving hemostatic success at 10 minutes following treatment application. | Posted | Count of Participants | Participants | Intraoperative, 10 minutes following treatment application |
|
|
|
| Secondary | Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment | The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had re-bleeding requiring treatment | Subjects who established TBS hemostasis at 3 minutes | Posted | Count of Participants | Participants | Intra-operative, prior initiation of final chest wall closure. Safety Issue: |
|
|
|
| Secondary | Number of Participants With Adverse Events Potentially Related to Thrombotic Events | The number of subjects with an adverse event potentially related to a thrombotic event | Posted | Count of Participants | Participants | 30 days (+ 14 days) following surgery |
|
|
|
| 3 |
| 13 |
| 13 |
| 13 |
| EG001 | Topical Hemostat | Equine collagen sponge with Human Fibrinogen and Human Thrombin | 10 | 18 | 18 | 18 |
| EG002 | Standard of Care (SoC) | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. | 6 | 11 | 11 | 11 |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| ALCOHOL WITHDRAWAL SYNDROME | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
|
| SPINAL CORD ISCHAEMIA | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| CLOSTRIDIAL INFECTION | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| SINUS BRADYCARDIA | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| ATRIAL FLUTTER | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| COAGULOPATHY | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| HAEMATOMA | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| THORACIC CAVITY DRAINAGE | Surgical and medical procedures | MedDRA version 15.0 | Systematic Assessment |
|
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
|
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
|
| DECUBITUS ULCER | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| PULMONARY CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| DELIRIUM | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
|
| ALCOHOL WITHDRAWAL SYNDROME | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
|
| AGITATION | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
|
| SPINAL CORD ISCHAEMIA | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
|
| FRACTURE MALUNION | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
|
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| LACTIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| HYPERVOLAEMIA | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| HYPERNATRAEMIA | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| ACIDOSIS | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
|
| RED BLOOD CELL COUNT DECREASED | Investigations | MedDRA version 15.0 | Systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA version 15.0 | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA version 15.0 | Systematic Assessment |
|
| HAEMATOCRIT DECREASED | Investigations | MedDRA version 15.0 | Systematic Assessment |
|
| BLOOD FIBRINOGEN INCREASED | Investigations | MedDRA version 15.0 | Systematic Assessment |
|
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | Investigations | MedDRA version 15.0 | Systematic Assessment |
|
| TRANSFUSION-RELATED ACUTE LUNG INJURY | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
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| LACERATION | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| INCISION SITE PAIN | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| ANAEMIA POSTOPERATIVE | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| FUNGAL INFECTION | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| CLOSTRIDIAL INFECTION | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| BACTERAEMIA | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| OEDEMA | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| HYPOTHERMIA | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| EFFUSION | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| PEPTIC ULCER | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| GASTRITIS | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| FLATULENCE | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
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| TACHYCARDIA | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
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| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
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| SINUS BRADYCARDIA | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
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| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
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| CARDIAC TAMPONADE | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
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| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| ATRIOVENTRICULAR BLOCK | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| ATRIAL FLUTTER | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
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| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
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| COAGULOPATHY | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
|
Not provided
| D019984 |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |