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The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral antithrombotic therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Argatroban | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| argatroban | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation | During and 30 days after argatroban treatment | |
| All-cause Death | During and 30 days after argatroban treatment | |
| Death Related to Heparin-induced Thrombocytopenia (HIT) | During and 30 days after argatroban treatment | |
| Number of Patients With Thrombosis (New and Extended) | During and 30 days after argatroban treatment | |
| Number of Patients With Unplanned Amputation | During and 30 days after argatroban treatment | |
| Number of Patients With Major or Minor Bleeding | Major bleeding is defined as i) overt and associated with a fall in the haemoglobin level 2 g/dl or more, ii) leads to transfusion of 2 units or more, iii) is retroperitoneal, iv) occurs into a major prosthetic joint, or v) in intracranial. Minor bleeding is defined as overt bleeding that does not meet the criteria of major bleeding. | During and 30 days after argatroban treatment |
| Number of Patients With Platelet Count Recovery | Platelet increase of ≥ 100G/L or 50%. | Day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor | Information at Mitsubishi Pharma Europe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint-Etienne | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26556106 | Result | Tardy-Poncet B, Nguyen P, Thiranos JC, Morange PE, Biron-Andreani C, Gruel Y, Morel J, Wynckel A, Grunebaum L, Villacorta-Torres J, Grosjean S, de Maistre E. Argatroban in the management of heparin-induced thrombocytopenia: a multicenter clinical trial. Crit Care. 2015 Nov 11;19:396. doi: 10.1186/s13054-015-1109-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Argatroban | start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Argatroban | start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values |
| 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 of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation | Posted | Number | participants | During and 30 days after argatroban treatment |
|
|
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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 | Argatroban | start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DISSEMINATED INTRAVASCULAR COAGULATION | Blood and lymphatic system disorders | MedDRA ver 13.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA ver 13.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials, Information Desk | Tanabe Pharma Corporation | cti-inq-ml.JP@ml.tanabe-pharma.com |
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| ID | Term |
|---|---|
| C031942 | argatroban |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | All-cause Death | Posted | Number | participants | During and 30 days after argatroban treatment |
|
|
|
| Primary | Death Related to Heparin-induced Thrombocytopenia (HIT) | Posted | Number | participants | During and 30 days after argatroban treatment |
|
|
|
| Primary | Number of Patients With Thrombosis (New and Extended) | Posted | Number | participants | During and 30 days after argatroban treatment |
|
|
|
| Primary | Number of Patients With Unplanned Amputation | Posted | Number | participants | During and 30 days after argatroban treatment |
|
|
|
| Primary | Number of Patients With Major or Minor Bleeding | Major bleeding is defined as i) overt and associated with a fall in the haemoglobin level 2 g/dl or more, ii) leads to transfusion of 2 units or more, iii) is retroperitoneal, iv) occurs into a major prosthetic joint, or v) in intracranial. Minor bleeding is defined as overt bleeding that does not meet the criteria of major bleeding. | Posted | Number | participants | During and 30 days after argatroban treatment |
|
|
|
| Primary | Number of Patients With Platelet Count Recovery | Platelet increase of ≥ 100G/L or 50%. | Data are missing in 3 patients. | Posted | Number | participants | Day 3 |
|
|
|
| 14 |
| 20 |
| 17 |
| 20 |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA ver 13.1 |
|
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA ver 13.1 |
|
| CARDIAC ARREST | Cardiac disorders | MedDRA ver 13.1 |
|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA ver 13.1 |
|
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA ver 13.1 |
|
| MYOCARDIAL RUPTURE | Cardiac disorders | MedDRA ver 13.1 |
|
| PERITONITIS | Gastrointestinal disorders | MedDRA ver 13.1 |
|
| COLITIS | Gastrointestinal disorders | MedDRA ver 13.1 |
|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA ver 13.1 |
|
| PNEUMATOSIS INTESTINALIS | Gastrointestinal disorders | MedDRA ver 13.1 |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA ver 13.1 |
|
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA ver 13.1 |
|
| MULTI-ORGAN FAILURE | General disorders | MedDRA ver 13.1 |
|
| SEPSIS | Infections and infestations | MedDRA ver 13.1 |
|
| SEPTIC SHOCK | Infections and infestations | MedDRA ver 13.1 |
|
| MEDICATION ERROR | Injury, poisoning and procedural complications | MedDRA ver 13.1 |
|
| ACUTE PRERENAL FAILURE | Renal and urinary disorders | MedDRA ver 13.1 |
|
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
|
| LUNG DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
|
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA ver 13.1 |
|
| BLUE TOE SYNDROME | Vascular disorders | MedDRA ver 13.1 |
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| FEMORAL ARTERY EMBOLISM | Vascular disorders | MedDRA ver 13.1 |
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| HAEMORRHAGE | Vascular disorders | MedDRA ver 13.1 |
|
| JUGULAR VEIN THROMBOSIS | Vascular disorders | MedDRA ver 13.1 |
|
| PELVIC VENOUS THROMBOSIS | Vascular disorders | MedDRA ver 13.1 |
|
| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA ver 13.1 |
|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA ver 13.1 |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA ver 13.1 |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA ver 13.1 |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA ver 13.1 |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA ver 13.1 |
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| Bradycardia | Cardiac disorders | MedDRA ver 13.1 |
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| Mitral Valve Incompetence | Cardiac disorders | MedDRA ver 13.1 |
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| Tachycardia | Cardiac disorders | MedDRA ver 13.1 |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA ver 13.1 |
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| Colonic Polyp | Gastrointestinal disorders | MedDRA ver 13.1 |
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| Constipation | Gastrointestinal disorders | MedDRA ver 13.1 |
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| Diarrhoea | Gastrointestinal disorders | MedDRA ver 13.1 |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA ver 13.1 |
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| Ileus | Gastrointestinal disorders | MedDRA ver 13.1 |
|
| Impaired Gastric Emptying | Gastrointestinal disorders | MedDRA ver 13.1 |
|
| Melaena | Gastrointestinal disorders | MedDRA ver 13.1 |
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| Mouth Haemorrhage | Gastrointestinal disorders | MedDRA ver 13.1 |
|
| Nausea | Gastrointestinal disorders | MedDRA ver 13.1 |
|
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA ver 13.1 |
|
| Vomiting | Gastrointestinal disorders | MedDRA ver 13.1 |
|
| Asthenia | General disorders | MedDRA ver 13.1 |
|
| Chest Pain | General disorders | MedDRA ver 13.1 |
|
| Generalised Oedema | General disorders | MedDRA ver 13.1 |
|
| Hyperthermia | General disorders | MedDRA ver 13.1 |
|
| Inflammation | General disorders | MedDRA ver 13.1 |
|
| Injection Site Inflammation | General disorders | MedDRA ver 13.1 |
|
| Malaise | General disorders | MedDRA ver 13.1 |
|
| Oedema Peripheral | General disorders | MedDRA ver 13.1 |
|
| Pain | General disorders | MedDRA ver 13.1 |
|
| Puncture Site Haemorrhage | General disorders | MedDRA ver 13.1 |
|
| Pyrexia | General disorders | MedDRA ver 13.1 |
|
| Cholestasis | Hepatobiliary disorders | MedDRA ver 13.1 |
|
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA ver 13.1 |
|
| Jaundice | Hepatobiliary disorders | MedDRA ver 13.1 |
|
| Jaundice Cholestatic | Hepatobiliary disorders | MedDRA ver 13.1 |
|
| Liver Disorder | Hepatobiliary disorders | MedDRA ver 13.1 |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA ver 13.1 |
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| Device Related Infection | Infections and infestations | MedDRA ver 13.1 |
|
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA ver 13.1 |
|
| Fungal Infection | Infections and infestations | MedDRA ver 13.1 |
|
| Fungal Sepsis | Infections and infestations | MedDRA ver 13.1 |
|
| Gastroenteritis | Infections and infestations | MedDRA ver 13.1 |
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| Infection | Infections and infestations | MedDRA ver 13.1 |
|
| Lung Infection | Infections and infestations | MedDRA ver 13.1 |
|
| Pneumonia | Infections and infestations | MedDRA ver 13.1 |
|
| Postoperative Wound Infection | Infections and infestations | MedDRA ver 13.1 |
|
| Sepsis | Infections and infestations | MedDRA ver 13.1 |
|
| Sinusitis | Infections and infestations | MedDRA ver 13.1 |
|
| Urinary Tract Infection | Infections and infestations | MedDRA ver 13.1 |
|
| Haemodialysis Complication | Injury, poisoning and procedural complications | MedDRA ver 13.1 |
|
| Incision Site Pain | Injury, poisoning and procedural complications | MedDRA ver 13.1 |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA ver 13.1 |
|
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA ver 13.1 |
|
| Postoperative Wound Complication | Injury, poisoning and procedural complications | MedDRA ver 13.1 |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA ver 13.1 |
|
| Alpha Globulin Increased | Investigations | MedDRA ver 13.1 |
|
| Blood Pressure Decreased | Investigations | MedDRA ver 13.1 |
|
| Coagulation Time Prolonged | Investigations | MedDRA ver 13.1 |
|
| Cytomegalovirus Test Positive | Investigations | MedDRA ver 13.1 |
|
| Globulins Decreased | Investigations | MedDRA ver 13.1 |
|
| Glomerular Filtration Rate Increased | Investigations | MedDRA ver 13.1 |
|
| Haemoglobin Decreased | Investigations | MedDRA ver 13.1 |
|
| International Normalised Ratio Increased | Investigations | MedDRA ver 13.1 |
|
| Pulmonary Function Test Decreased | Investigations | MedDRA ver 13.1 |
|
| Transaminases Increased | Investigations | MedDRA ver 13.1 |
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| Weight Decreased | Investigations | MedDRA ver 13.1 |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA ver 13.1 |
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| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA ver 13.1 |
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| Folate Deficiency | Metabolism and nutrition disorders | MedDRA ver 13.1 |
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| Hypernatraemia | Metabolism and nutrition disorders | MedDRA ver 13.1 |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA ver 13.1 |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA ver 13.1 |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA ver 13.1 |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA ver 13.1 |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA ver 13.1 |
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| Hypovolaemia | Metabolism and nutrition disorders | MedDRA ver 13.1 |
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| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA ver 13.1 |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA ver 13.1 |
|
| Altered State Of Consciousness | Nervous system disorders | MedDRA ver 13.1 |
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| Depressed Level Of Consciousness | Nervous system disorders | MedDRA ver 13.1 |
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| Monoparesis | Nervous system disorders | MedDRA ver 13.1 |
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| Paraesthesia | Nervous system disorders | MedDRA ver 13.1 |
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| Polyneuropathy | Nervous system disorders | MedDRA ver 13.1 |
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| Somnolence | Nervous system disorders | MedDRA ver 13.1 |
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| Anxiety | Psychiatric disorders | MedDRA ver 13.1 |
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| Confusional State | Psychiatric disorders | MedDRA ver 13.1 |
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| Depression | Psychiatric disorders | MedDRA ver 13.1 |
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| Insomnia | Psychiatric disorders | MedDRA ver 13.1 |
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| Sleep Disorder | Psychiatric disorders | MedDRA ver 13.1 |
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| Calculus Bladder | Renal and urinary disorders | MedDRA ver 13.1 |
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| Dysuria | Renal and urinary disorders | MedDRA ver 13.1 |
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| Haematuria | Renal and urinary disorders | MedDRA ver 13.1 |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA ver 13.1 |
|
| Renal Impairment | Renal and urinary disorders | MedDRA ver 13.1 |
|
| Acute Lung Injury | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
|
| Bronchial Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
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| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
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| Hypocapnia | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
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| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
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| Lung Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
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| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
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| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA ver 13.1 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA ver 13.1 |
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| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA ver 13.1 |
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| Skin Dystrophy | Skin and subcutaneous tissue disorders | MedDRA ver 13.1 |
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| Aortic Arteriosclerosis | Vascular disorders | MedDRA ver 13.1 |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA ver 13.1 |
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| Haemodynamic Instability | Vascular disorders | MedDRA ver 13.1 |
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| Hypertension | Vascular disorders | MedDRA ver 13.1 |
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| Hypotension | Vascular disorders | MedDRA ver 13.1 |
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| Venous Thrombosis | Vascular disorders | MedDRA ver 13.1 |
|
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