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The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). The data obtained in this study will evaluate this next generation device as compared to outcomes of prior studies conducted with the GORE® HELEX® Septal Occluder.
Ostium secundum atrial septal defects present as a persistent communication between the atria and are a common congenital cardiac anomaly accounting for approximately 10% of all congenital heart disease. They are one of the most common congenital heart defects to present in adulthood. Untreated, ASDs produce right heart volume overload and progressive impairment over time, including reduced aerobic capacity, atrial dysrhythmias, congestive heart failure, pulmonary hypertension, and potential paradoxical embolism. In the U.S. alone it is estimated that approximately 10,000 new patients per year can be expected to have an ASD. Successful surgical repair of ASD has been performed for 50 years with continued improvement in technique and outcomes. King and Mills reported the first transcatheter closure of ASD in 1976, but the delivery system was quite large and impractical, especially for younger patients. With time, improvements in design concepts and materials discoveries have led to improved results in transcatheter closure systems. Several devices are now available commercially for transcatheter ASD closure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Device | Experimental | ASD closure with the GORE® CARDIOFORM Septal Occluder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® CARDIOFORM Septal Occluder | Device | Percutaneous Atrial Septal Defect Closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With 6-Month Composite Clinical Success | Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Technical Success | Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder | During procedure; median duration 68 minutes |
| Number of Subjects With Procedure Success |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| D. Scott Lim, MD | University of Virginia, Children's Hospital Heart Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia, Children's Hospital Heart Center | Charlottesville | Virginia | 22908 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Device | ASD closure with the GORE® CARDIOFORM Septal Occluder Percutaneous Atrial Septal Defect Closure |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6-Month Clinical Success Evaluation |
|
| ||||||||||||||||||
| 6-Month Closure Evaluation |
| |||||||||||||||||||
| 36-Month Closure Evaluation |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Device | ASD closure with the GORE® CARDIOFORM Septal Occluder |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Subjects With 6-Month Composite Clinical Success | Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components:
| All enrolled subjects with 6-month clinical success evaluation | Posted | Count of Participants | Participants | 6 months |
|
3 years (1,155 days: 1,095 days + 60-day window)
SAEs follow definition of SAE from ISO 14155.
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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 | Test Device | ASD closure with the GORE® CARDIOFORM Septal Occluder | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bryan Randall | W. L. Gore & Associates | 928-864-4832 | BRandall@WLGore.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2014 | Jun 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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Among subjects with attempted study device closure, the number of subjects with technical success and less than or equal to 2 mm residual shunt of the target ASD at conclusion of the index procedure. |
| During procedure; median duration 68 minutes |
| Number of Subjects With 30-day SAE | Among subjects with attempted study device closure, the number of subjects experiencing one or more serious adverse events (SAEs) within 30 days post-index procedure | 30 days |
| Number of Subjects With 6-Month Closure Success | Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation. | 6 months |
| Number of Subjects With 12-Month Closure Success | Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 12-month evaluation. | 12 months |
| Number of Subjects With 36-Month Closure Success | Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 36-month evaluation. | 36 months |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Median | Full Range | cm |
|
| Weight | Median | Full Range | kg |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Cigarette Smoking | Count of Participants | Participants |
|
| Headaches | Count of Participants | Participants |
|
| Migraines | Count of Participants | Participants |
|
| Cardiac Arrhythmia History | Count of Participants | Participants |
|
| Stop Flow Balloon Defect Size | Enrolled subjects with non-missing measurement | Median | Full Range | mm |
|
| Multiple Fenestrations | Count of Participants | Participants |
|
| Atrial Septal Aneurysm | Count of Participants | Participants |
|
| Septal Length | Enrolled subjects with non-missing measurement | Median | Full Range | mm |
|
| Anterior-Superior Aortic Rim Length | Enrolled subjects with non-missing measurement | Median | Full Range | mm |
|
ASD closure with the GORE® CARDIOFORM Septal Occluder
|
|
|
| Secondary | Number of Subjects With Technical Success | Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder | Posted | Count of Participants | Participants | During procedure; median duration 68 minutes |
|
|
|
| Secondary | Number of Subjects With Procedure Success | Among subjects with attempted study device closure, the number of subjects with technical success and less than or equal to 2 mm residual shunt of the target ASD at conclusion of the index procedure. | Posted | Count of Participants | Participants | During procedure; median duration 68 minutes |
|
|
|
| Secondary | Number of Subjects With 30-day SAE | Among subjects with attempted study device closure, the number of subjects experiencing one or more serious adverse events (SAEs) within 30 days post-index procedure | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Number of Subjects With 6-Month Closure Success | Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation. | Enrolled subjects with technical success and 6-month clinical residual defect status evaluation | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Subjects With 12-Month Closure Success | Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 12-month evaluation. | Enrolled subjects with technical success and 12-month clinical residual defect status evaluation | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Subjects With 36-Month Closure Success | Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 36-month evaluation. | Enrolled subjects with technical success and 36-month clinical residual defect status evaluation | Posted | Count of Participants | Participants | 36 months |
|
|
|
| 400 |
| 28 |
| 400 |
| 260 |
| 400 |
| Angina pectoris | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Atrial thrombosis | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Frenulum breve | Congenital, familial and genetic disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Middle ear effusion | Ear and labyrinth disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Medical device site thrombosis | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Amyloidosis | Immune system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Streptococcal sepsis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Foreign body in gastrointestinal tract | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Post concussion syndrome | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Penile adhesion | Reproductive system and breast disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Pharyngeal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Caesarean section | Surgical and medical procedures | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Cardiac septal hypertrophy | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Dilatation atrial | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Left ventricular dilatation | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Left ventricular hypertrophy | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Nodal rhythm | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Postural orthostatic tachycardia syndrome | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Pulmonary valve stenosis | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Williams syndrome | Congenital, familial and genetic disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Thyroid disorder | Endocrine disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Orbital cyst | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Strabismus | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Axillary pain | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Cardiac complication associated with device | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Decreased activity | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Exercise tolerance decreased | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Infusion site extravasation | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Nodule | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Swelling | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Multiple allergies | Immune system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Bacterial disease carrier | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Enterovirus infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Gastrointestinal viral infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Lyme disease | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Oral viral infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Otitis media chronic | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Rotavirus infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Staphylococcal skin infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Viral rash | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Vulvovaginitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Anaesthetic complication | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Anaesthetic complication cardiac | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Anaesthetic complication pulmonary | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Cardiac procedure complication | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Deep vein thrombosis postoperative | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Delayed recovery from anaesthesia | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Incision site complication | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Incision site haematoma | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Incision site rash | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Post procedural fever | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Splinter | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Superficial injury of eye | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Chest X-ray abnormal | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Appetite disorder | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Infrapatellar fat pad inflammation | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Juvenile idiopathic arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Allodynia | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Migraine with aura | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Migraine without aura | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Vocal cord paresis | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Device issue | Product Issues | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Hallucination, auditory | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Penile curvature | Reproductive system and breast disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Bronchomalacia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Tonsillar inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Mechanical urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Air embolism | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Angiopathy | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Carotidynia | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Labile hypertension | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Vascular dissection | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
Not provided
Not provided
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |