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| Name | Class |
|---|---|
| Groupe Hospitalier de la Rochelle Ré Aunis | OTHER |
| Centre Hospitalier de Rochefort | OTHER |
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Giant cell arteritis (GCA or temporal arteritis or cranial arteritis) or Horton disease is a vasculitis that occurs in older adults, affecting vessels of medium and large caliber. The diagnosis of GCA is a challenge for general practitioners and specialists. Since 1970, it is based on a combination of clinical, biological and histological signs. Temporal artery biopsy (TAB) was the reference method until recently. However, TAB has many drawbacks. Therefore, researches of the past 20 years have been intended to develop alternative diagnostic methods. This was notably the case of the color Doppler ultrasound (CDU) since the description by Wolfgang Schmidt of the halo sign. Although European and British recommendations put CDU as second line method, many authors suggest the possibility to do without TAB in many cases. In addition, many practitioners believe that it is not "ethical" to use an invasive unprofitable procedure like TAB, and have already been using CDU in their routine practice. However, no diagnostic algorithm validating this approach in a prospective series has been published to date. Therefore, the present study aim at validating a diagnostic algorithm of giant cell arteritis using color Doppler imaging of temporal arteries and cervicocephalic axes as first screening method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GCA suspicion | Other | A first screening is performed using color Doppler ultrasound. In case of negative results, patients undergo TAB. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| color Doppler ultrasound and TAB in case of CDU negative | Other | Screening with color Doppler ultrasound followed by TAB in case of CDU negative |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of CDU False-positive Patients | patients with an alternative diagnosis within 2 years of follow-up among patients considered with giant cell arteritis (GCA) on a clinico-biological suspicion + Doppler "positive." | after 2 years of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of "Temporal Artery Biopsy Positive" Among "Negative or Doubtful CDU " | Number of temporal artery biopsy (TAB) positive patients among patients with negative or doubtful CDU | within 1 month (during diagnostic algorithm) |
| Number of Patients With a Persistent Halo at Second CDU Examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Roncato, MD | Groupe Hospitalier de la Rochelle Ré Aunis | Study Director |
| Guillaume Denis, MD | Centre Hospitalier de Rochefort | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Angoulême | Angoulême | France | ||||
| Groupe Hospitalier de la Rochelle Ré Aunis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25337759 | Background | Weyand CM, Goronzy JJ. Giant-cell arteritis and polymyalgia rheumatica. N Engl J Med. 2014 Oct 23;371(17):1653. doi: 10.1056/NEJMc1409206. No abstract available. | |
| 25041449 | Background | Smith JH, Swanson JW. Giant cell arteritis. Headache. 2014 Sep;54(8):1273-89. doi: 10.1111/head.12425. Epub 2014 Jul 18. |
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Recruitment period: from end of August 2016 to February 2020 Type of location: five public hospitals
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| ID | Title | Description |
|---|---|---|
| FG000 | CDU Positive | A first screening is performed using color Doppler ultrasound (CDU). "CDU Positive" refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound |
| FG001 | CDU Negative | A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | CDU Positive | A first screening is performed using color Doppler ultrasound (CDU). "CDU Positive" refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound |
| 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 | Number of CDU False-positive Patients | patients with an alternative diagnosis within 2 years of follow-up among patients considered with giant cell arteritis (GCA) on a clinico-biological suspicion + Doppler "positive." | Patients followed up at two years | Posted | Count of Participants | Participants | after 2 years of follow-up |
|
Two years after inclusion
This study concern patients with high clinical suspicion of GCA defined by 2 mandatory criteria that were age >50 and biological inflammatory syndrome with C-Reactive Protein elevation, and at least one of the following factors: abnormal temporal arteries, scalp hyperesthesia, jaw claudication, vision loss, pain in the shoulder girdle or pelvic girdle, unusual headache, impaired general condition, fever, or imaging positive result and absence of obvious differential diagnosis.
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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 | CDU Positive | A first screening is performed using color Doppler ultrasound (CDU). "CDU Positive" refers to patients with a bilateral clear halo sign (defined as homogenous, hypoechoic wall thickening, well-delineated toward the luminal side, visible both in longitudinal and transverse planes located on the superficial temporal arteries, trunk or branches) detected by color Doppler ultrasound resonance angiography and/or positron emission tomography and absence of obvious differential diagnosis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute prostatitis | Renal and urinary disorders | MedDRA 24.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal weight gain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Allix-Béguec, clinical research manager | Groupe Hospitalier de la Rochelle Ré Aunis | +33516494246 | caroline.allix-beguec@ght-atlantique17.fr |
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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 | Sep 4, 2017 | Apr 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Describe S3/S4 Halo changes, and study correlation between persistence and poorer clinical response |
| after 2 years of follow-up |
| Number of Correctly Interpreted TAB | Reproducibility of TAB interpretation | 1 month (after second blind reading of histological specimen and doppler imaging) |
| Number of Correctly Interpreted CDU | Reproducibility of CDU interpretation | 1 month (after second blind reading of histological specimen and doppler imaging) |
| La Rochelle |
| 17019 |
| France |
| Centre Hospitalier Universitaire de Nantes | Nantes | France |
| Centre Hospitalier de Niort | Niort | 79021 | France |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | 86021 | France |
| Centre Hospitalier de Rochefort | Rochefort | 17301 | France |
| 25132663 | Background | Petri H, Nevitt A, Sarsour K, Napalkov P, Collinson N. Incidence of giant cell arteritis and characteristics of patients: data-driven analysis of comorbidities. Arthritis Care Res (Hoboken). 2015 Mar;67(3):390-5. doi: 10.1002/acr.22429. |
| 13679546 | Background | Calvo-Romero JM. Giant cell arteritis. Postgrad Med J. 2003 Sep;79(935):511-5. doi: 10.1136/pmj.79.935.511. |
| 10218393 | Background | Roblot P. [When should Horton's disease be suspected?]. Rev Prat. 1999 Mar 15;49(6):593-7. French. |
| 25122725 | Background | Baslund B, Helleberg M, Faurschou M, Obel N. Mortality in patients with giant cell arteritis. Rheumatology (Oxford). 2015 Jan;54(1):139-43. doi: 10.1093/rheumatology/keu303. Epub 2014 Aug 13. |
| 14674005 | Background | Nuenninghoff DM, Hunder GG, Christianson TJ, McClelland RL, Matteson EL. Mortality of large-artery complication (aortic aneurysm, aortic dissection, and/or large-artery stenosis) in patients with giant cell arteritis: a population-based study over 50 years. Arthritis Rheum. 2003 Dec;48(12):3532-7. doi: 10.1002/art.11480. |
| 23253927 | Background | Kermani TA, Warrington KJ, Crowson CS, Ytterberg SR, Hunder GG, Gabriel SE, Matteson EL. Large-vessel involvement in giant cell arteritis: a population-based cohort study of the incidence-trends and prognosis. Ann Rheum Dis. 2013 Dec;72(12):1989-94. doi: 10.1136/annrheumdis-2012-202408. Epub 2012 Dec 19. |
| 2202311 | Background | Hunder GG, Bloch DA, Michel BA, Stevens MB, Arend WP, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, Lie JT, et al. The American College of Rheumatology 1990 criteria for the classification of giant cell arteritis. Arthritis Rheum. 1990 Aug;33(8):1122-8. doi: 10.1002/art.1780330810. |
| 16901030 | Background | Hunder GG. The early history of giant cell arteritis and polymyalgia rheumatica: first descriptions to 1970. Mayo Clin Proc. 2006 Aug;81(8):1071-83. doi: 10.4065/81.8.1071. |
| 41144031 | Derived | Roncato C, Allix-Beguec C, Bourgade R, Becker F, Goujon JM, Denis G, Espitia O. Temporal artery biopsy and temporal artery ultrasound inter-rater agreement for the diagnosis of giant cell arteritis: an ancillary analysis from the multicentre prospective ECHORTON study. Rheumatol Int. 2025 Oct 27;45(11):260. doi: 10.1007/s00296-025-06009-9. |
| 38710093 | Derived | Denis G, Espitia O, Allix-Beguec C, Dieval C, Lorcerie F, Gombert B, Pouget-Abadie X, Toquet C, Agard C, Raimbeau A, Gautier G, Goujon JM, Durand G, Thollot-Karolewicz C, Lormeau C, Grados A, Grenot-Mercier A, El-Khoury R, Riche A, Hospital F, Visee S, Auriault ML, Landron C, Martin M, Roncato C. Diagnostic Strategy Using Color Doppler Ultrasound of Temporal Arteries in Patients With High Clinical Suspicion of Giant Cell Arteritis : A Prospective Cohort Study. Ann Intern Med. 2024 Jun;177(6):729-737. doi: 10.7326/M23-3417. Epub 2024 May 7. |
| BG001 | CDU Negative | A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery. |
| 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 |
|
| CDU Negative |
A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery. |
|
|
| Secondary | Rate of "Temporal Artery Biopsy Positive" Among "Negative or Doubtful CDU " | Number of temporal artery biopsy (TAB) positive patients among patients with negative or doubtful CDU | Posted | Count of Participants | Participants | within 1 month (during diagnostic algorithm) |
|
|
|
| Secondary | Number of Patients With a Persistent Halo at Second CDU Examination | Describe S3/S4 Halo changes, and study correlation between persistence and poorer clinical response | Posted | Count of Participants | Participants | after 2 years of follow-up |
|
|
|
| Secondary | Number of Correctly Interpreted TAB | Reproducibility of TAB interpretation | According to the diagnostic algorithm, only ultrasound-negative patients underwent temporal artery biopsy within 7 days after the ultrasound | Posted | Count of Participants | Participants | 1 month (after second blind reading of histological specimen and doppler imaging) |
|
|
|
| Secondary | Number of Correctly Interpreted CDU | Reproducibility of CDU interpretation | Posted | Count of Participants | Participants | 1 month (after second blind reading of histological specimen and doppler imaging) |
|
|
|
| 5 |
| 73 |
| 12 |
| 73 |
| 51 |
| 73 |
| EG001 | CDU Negative | A first screening is performed using color Doppler ultrasound (CDU). "CDU negative" refers to patient with no sign or a unilateral halo sign on the temporal artery. | 8 | 92 | 18 | 92 | 50 | 92 |
| Aneamia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Aneurysm of abdominal aorta | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Aortic dissection rupture | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Carotid artery stenosis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cerebral vasculitis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cognitive disorders | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Covid-19 respiratory infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Dental abscess | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Dysfunction kidney | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Faint | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Femoral neck fracture | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fracture due to osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fracture of vertebral column without mention of spinal cord injury | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Generalised chest pains | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hemithyroidectomy | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| High grade atrioventricular block | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyponatraemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ischemic colitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Kidney failure | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Leukemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lumbar vertebral fracture L1 | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myelodysplasia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Osteoporosis steroid-induced | Product Issues | MedDRA 24.0 | Systematic Assessment |
|
| Pachymeningitis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Palsy | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Spondylodiscitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tongue necrosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urticaria recurrent | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Venous obstruction | Vascular disorders | MedDRA 24.0 | Non-systematic Assessment |
|
| Abscesses of skin | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute kidney failure | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Adenoma | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Amaurosis | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Amyotrophy | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Aneamia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anorexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Antral gastritis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Anxiodepressive syndrome | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Aortitis | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arnold neuralgia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arteritic anterior ischaemic optic neuropathy | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Back ache | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bateman's purpura senilis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Belly ache | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bleeding piles | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Blepharitis unspecified | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Calf swelling | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Carcinoma | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cervical pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chronic myelomonocytic leukemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Claudication of jaw muscles | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cognitive disorders | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Coxarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cramps | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| C-reactive protein increased | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cushingoid facies | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diabetes mellitus | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dry eyes | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Epistaxis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Erythematous eruption | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fall | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Finger dislocation | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fixed pigmented erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Flexor tendon rupture | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Flu | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Gastric infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Giant cell arteritis relapse | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Glaucoma unspecified | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hallucination | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Heart failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hematoma | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hot flushes facial | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypertension | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Idiopathic midline granuloma | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Inflammatory rheumatism | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Insomnia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Joint prothesis removal | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Junctional tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Knee osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lens luxation | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lumbar pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lump excision | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Lung nodule | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Memory disturbance | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Monocytosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Muscle pains | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Mycosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Myeloproliferative disorder | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Neovascular glaucoma | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oesophageal dysphagia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Olecranon bursitis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Optic ischaemic neuropathy | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Orthostatic hypotension | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Osteoarthritis of neck | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain in ankle | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pancreatic lesion | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Peripheral lipodystrophy | Product Issues | MedDRA 24.0 | Systematic Assessment |
|
| Peripheral neuropathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumopathy | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Polymyalgia rheumatica | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ptosis | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rheumatism | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rheumatoid vasculitis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rib fracture | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rupture of muscle non-traumatic | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Shoulder and hand pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Situational anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sleep apnea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Sleep disorder | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Spontaneous ecchymoses | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Subacromial bursitis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| cataract | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
|
| Sweating | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Telogen effluvium | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thyroid nodule (nontoxic) | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thyroiditis | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tingling sensation | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Visual acutity reduced | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Wound | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Wound dehiscence | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Not done |
|
| Not available |
|
| Blinded expert analysis |
|
| Not available |
|
| Blinded expert analysis |
|