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To obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in hypertensive subjects in the absence of antihypertensive medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm: | Experimental | Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter |
|
| Sham Control Arm | Sham Comparator | Only renal angiography performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol | Drug | Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Systolic Ambulatory Blood Pressure | Change from baseline in mean 24-hour ambulatory systolic blood pressure | Baseline to 8 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months | Change from baseline in mean 24-hour ambulatory systolic blood pressure from baseline to 6 months | 6 months |
| Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felix Mahfoud, Prof.Dr.med. | Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin, Germany | Principal Investigator |
| Atul Pathak, Prof. | Clinique Pasteur Hi-LAB, Toulouse, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium | |||
| Clinique Pasteur Toulouse |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37427416 | Background | Pathak A, Rudolph UM, Saxena M, Zeller T, Muller-Ehmsen J, Lipsic E, Schmieder RE, Sievert H, Halbach M, Sharif F, Parise H, Fischell TA, Weber MA, Kandzari DE, Mahfoud F. Alcohol-mediated renal denervation in patients with hypertension in the absence of antihypertensive medications. EuroIntervention. 2023 Sep 18;19(7):602-611. doi: 10.4244/EIJ-D-23-00088. | |
| 32958438 |
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Enrolled and consented (n=350)
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Control Arm | Only renal angiography performed Sham control: endovascular, renal angiography |
| FG001 | Treatment Arm: | Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm: | Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries |
| BG001 | Sham Control Arm |
| 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 | Changes in Systolic Ambulatory Blood Pressure | Change from baseline in mean 24-hour ambulatory systolic blood pressure | Posted | Mean | Standard Deviation | mmHg | Baseline to 8 weeks post-treatment |
|
12 months
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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 | Sham Control Arm | Only renal angiography performed Sham control: endovascular, renal angiography |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA 21.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate Rumrill, CEO | Ablative Solutions Inc | 1 650-688-9743 | krumrill@ablativesolutions.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 | Dec 14, 2021 | Oct 6, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 19, 2021 | Oct 5, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
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Subjects who continue to be eligible at the end of the run-in period will be randomized in a 1:1 ratio to one of the following 2 groups via central randomization (stratified by study site):
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Blinded (The subject, sponsor, and hypertensionist/nephrologist performing the screening and follow-up assessments are blinded. The interventionalist and cath lab staff are unblinded.)
| Sham control | Other | endovascular, renal angiography |
|
Change from baseline in mean 24-hour systolic blood pressure at 12 months post-procedure
| 12 months |
| Change in Office SBP at 8 Weeks | Change from Baseline in mean office SBP to Week 8 | 8 weeks |
| Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks | Change from baseline in mean 24-hour ambulatory diastolic blood pressure and 8 weeks post-procedure | 8 weeks |
| Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months | Change from baseline in mean 24-hour ambulatory diastolic blood pressure at 6 months post-procedure | 6 months |
| Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months | Change from baseline in mean 24-hour diastolic blood pressure 12 months post-procedure | 12 months |
| Number of Participants With Major Adverse Events (MAEs) | Number of participants with major adverse events (MAEs) 30 days post-procedure | 30 days post procedure |
| Use of Antihypertensive Medication(s) | Use of antihypertensive medication at 8 weeks | 8 weeks |
| Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 8 Weeks | 8 weeks |
| Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 6 Months | 6 months |
| Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 12 Months | 12 months |
| Mean Daytime Ambulatory Diastolic Blood Pressure | Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 8 Weeks | 8 weeks |
| Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months | Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 6 months | 6 months |
| Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months | Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 12 Months | 12 months |
| Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 8 Weeks | 8 weeks |
| Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 6 Months | 6 months |
| Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months | 12 months |
| Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 8 weeks | 8 weeks |
| Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 6 Months | 6 months |
| Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 12 Months | 12 months |
| Change in Mean Office SBP at 6 Months | Change from Baseline in mean office SBP to 6 Months | 6 months |
| Change in Mean Office SBP to 12 Months | Change from Baseline in mean office SBP to 12 Months | 12 months |
| Change in Mean Office DBP to 8 Weeks | Change from Baseline in mean office DBP to 8 Weeks | 8 weeks |
| Change in Mean Office DBP to 6 Months | Change from Baseline in mean office DBP to 6 Months | 6 months |
| Change in Mean Office DBP at 12 Months | Change from Baseline in mean office DBP to 12 Months | 12 months |
| Toulouse |
| France |
| Universitätsklinikum des Saarlandes | Homburg/Saar | 66421 | Germany |
| NIHR Barts Cardiovascular Biomedical Research Unit | London | EC1M 6BQ | United Kingdom |
| Bertog S, Sharma A, Mahfoud F, Pathak A, Schmieder RE, Sievert K, Papademetriou V, Weber MA, Haratani N, Lobo MD, Saxena M, Kandzari DE, Fischell TA, Sievert H. Alcohol-Mediated Renal Sympathetic Neurolysis for the Treatment of Hypertension: The Peregrine Infusion Catheter. Cardiovasc Revasc Med. 2021 Mar;24:77-86. doi: 10.1016/j.carrev.2020.09.003. Epub 2020 Sep 7. |
| Not completing the primary ABPM |
|
| Not meeting inclusion/exclusion criteria |
|
Only renal angiography performed Sham control: endovascular, renal angiography |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| eGFR | Mean | Standard Deviation | mL/min per 1.73 m^2 |
|
| Diabetes (type 2) | Count of Participants | Participants |
|
| Smoking (current) | Count of Participants | Participants |
|
| Peripheral vascular occlusive disease | Count of Participants | Participants |
|
| Angiographically determined coronary artery disease | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months | Change from baseline in mean 24-hour ambulatory systolic blood pressure from baseline to 6 months | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
|
| Secondary | Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months | Change from baseline in mean 24-hour systolic blood pressure at 12 months post-procedure | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
|
| Secondary | Change in Office SBP at 8 Weeks | Change from Baseline in mean office SBP to Week 8 | Posted | Mean | Standard Deviation | mmHg | 8 weeks |
|
|
|
| Secondary | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks | Change from baseline in mean 24-hour ambulatory diastolic blood pressure and 8 weeks post-procedure | Posted | Mean | Standard Deviation | mmHg | 8 weeks |
|
|
|
|
| Secondary | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months | Change from baseline in mean 24-hour ambulatory diastolic blood pressure at 6 months post-procedure | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| Secondary | Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months | Change from baseline in mean 24-hour diastolic blood pressure 12 months post-procedure | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
|
| Secondary | Number of Participants With Major Adverse Events (MAEs) | Number of participants with major adverse events (MAEs) 30 days post-procedure | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
|
| Secondary | Use of Antihypertensive Medication(s) | Use of antihypertensive medication at 8 weeks | Posted | Mean | Standard Deviation | medications | 8 weeks |
|
|
|
|
| Secondary | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 8 Weeks | Posted | Mean | Standard Deviation | mmHg | 8 weeks |
|
|
|
| Secondary | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 6 Months | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| Secondary | Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months | Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 12 Months | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
| Secondary | Mean Daytime Ambulatory Diastolic Blood Pressure | Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 8 Weeks | Posted | Mean | Standard Deviation | mmHg | 8 weeks |
|
|
|
| Secondary | Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months | Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 6 months | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| Secondary | Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months | Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 12 Months | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
| Secondary | Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 8 Weeks | Posted | Mean | Standard Deviation | mmHg | 8 weeks |
|
|
|
| Secondary | Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 6 Months | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| Secondary | Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months | Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
| Secondary | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 8 weeks | Posted | Mean | Standard Deviation | mmHg | 8 weeks |
|
|
|
| Secondary | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 6 Months | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| Secondary | Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months | Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 12 Months | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
| Secondary | Change in Mean Office SBP at 6 Months | Change from Baseline in mean office SBP to 6 Months | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| Secondary | Change in Mean Office SBP to 12 Months | Change from Baseline in mean office SBP to 12 Months | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
| Secondary | Change in Mean Office DBP to 8 Weeks | Change from Baseline in mean office DBP to 8 Weeks | Posted | Mean | Standard Deviation | mmHg | 8 weeks |
|
|
|
| Secondary | Change in Mean Office DBP to 6 Months | Change from Baseline in mean office DBP to 6 Months | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
|
| Secondary | Change in Mean Office DBP at 12 Months | Change from Baseline in mean office DBP to 12 Months | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
| 0 |
| 56 |
| 9 |
| 56 |
| 42 |
| 56 |
| EG001 | Treatment Arm: | Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter Alcohol: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries | 0 | 50 | 7 | 50 | 41 | 50 |
| Abdominal abscess | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Lumbar vertebral fracture | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Urethral stenosis | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Mitral valve repair | Surgical and medical procedures | MedDRA 21.0 | Non-systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Glomerular filtration rate decreased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Chest discomfort | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dyspnoea exertional | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Coeliac artery compression syndrome | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Gastroenteritis viral | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Haemorrhoids thrombosed | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Drug intolerance | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Puncture site haematoma | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Puncture site haemorrhage | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Sinusitis | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Arterial intramural haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Blood pressure diastolic increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Protein deficiency | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Lumbar vertebral fracture | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Restlessness | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Urethral stenosis | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Acarodermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Apicectomy | Surgical and medical procedures | MedDRA 21.0 | Non-systematic Assessment |
|
| Mitral valve repair | Surgical and medical procedures | MedDRA 21.0 | Non-systematic Assessment |
|
| Varicose vein operation | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Aneurysm | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Arterial disorder | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dizziness | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypertensive urgency | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Peripheral venous disease | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Post procedural haematoma | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Renal artery dissection | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Syncope | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
Not provided
Not provided