Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-31 @ 10:18 PM
Study NCT ID:
NCT01645306
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2012-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Revacept in Symptomatic Carotid Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D020757', 'term': 'Amaurosis Fugax'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D001766', 'term': 'Blindness'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C559357', 'term': 'Revacept'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'muench@advancecor.com', 'phone': '+4989200020410', 'title': 'Prof. Dr. Götz Münch, CRP & CEO', 'organization': 'advanceCOR GmbH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was originally planned as primary endpoint study for the evaluation of reduction of micro-embolic signals (MES) by transcranial Doppler (TCD). Therefore MES incidence was a key inclusion criteria at screening. Due to low incidence of MES in this patient population with high screening failure rate the mandatory presence of MES was abandoned during the course of the study. Consecutively the study was changed to an explorative study of the same protocol specified endpoints.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event Data was gathered at a 3 month follow up visit in the clinic and up to one year by a telephone interview.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nPlacebo: single intravenous injection', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 18, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': '40 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 24, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': '120 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 17, 'seriousNumAtRisk': 53, 'deathsNumAffected': 1, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Oedama peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}], 'seriousEvents': [{'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Carotid Endarterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Chemotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Coronary angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Coronary arterial stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Skin lesion removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Vocal cordectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Glottis carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Sarcoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Cerebral hyperperfusion syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Angiocardiogram', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Biopsy larynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Cardiac clearance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Diffusion-weighted brain MRI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Weight decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Cerebral ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Clumsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Postictal paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Stroke in evolution', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Intervertebral disc prorusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0 EN)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'New DWI Lesion(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nPlacebo: single intravenous injection'}, {'id': 'OG001', 'title': '40 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}, {'id': 'OG002', 'title': '120 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day post intervention', 'description': 'The number of new diffusion weighted imaging (DWI) lesion(s) reported. (1 day after intervention compared to baseline).', 'unitOfMeasure': 'Number of new lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patients With Any Stroke or Transient Ischemic Attack (TIA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nPlacebo: single intravenous injection'}, {'id': 'OG001', 'title': '40 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}, {'id': 'OG002', 'title': '120 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days after IMP application', 'description': 'patients with any stroke or TIA occuring within 90 days after IMP application.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Major Bleedings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nPlacebo: single intravenous injection'}, {'id': 'OG001', 'title': '40 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}, {'id': 'OG002', 'title': '120 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days after IMP application', 'description': 'patients with major bleedings occuring within 90 days after IMP application', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Any Clinical Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nPlacebo: single intravenous injection'}, {'id': 'OG001', 'title': '40 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}, {'id': 'OG002', 'title': '120 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '365 days after IMP application', 'description': 'patients with any stroke \\& TIA, myocardial infarction \\& percutaneous coronary intervention (PCI), death or bleeding within one year (365 days) after IMP application.', 'unitOfMeasure': 'Number of Events', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Anti-Drug Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nPlacebo: single intravenous injection'}, {'id': 'OG001', 'title': '40 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}, {'id': 'OG002', 'title': '120 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month (+/- 1 month) after IMP application', 'description': 'Anti-drug antibodies were measured at baseline and 3 month after IMP application.\n\nNumber of patients with positive anti-drug antibodies compared to baseline are counted.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nPlacebo: single intravenous injection'}, {'id': 'OG001', 'title': '40 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}, {'id': 'OG002', 'title': '120 mg Revacept', 'description': 'in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}], 'classes': [{'title': 'patients with adverse events', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'patients with drug related AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'patients with serious AEs', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'patients with drug related serious AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'patients with AE with fatal outcome events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '~ 365 days after IMP application (whole study period)', 'description': 'All adverse events were assessed during complete study period (\\~ 1 year after IMP application).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nPlacebo: single intravenous injection'}, {'id': 'FG001', 'title': '40 mg Revacept', 'description': '40 mg Revacept in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}, {'id': 'FG002', 'title': '120 mg Revacept', 'description': '120 mg in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nPlacebo: single intravenous injection'}, {'id': 'BG001', 'title': '40 mg Revacept', 'description': '40 mg Revacept in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}, {'id': 'BG002', 'title': '120 mg Revacept', 'description': '120 mg Revacept in phosphate buffered saline (PBS), 1% sucrose, 4% mannitol\n\nRevacept: single intravenous injection'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'spread': '10.25', 'groupId': 'BG000'}, {'value': '68.7', 'spread': '10.45', 'groupId': 'BG001'}, {'value': '68.4', 'spread': '9.82', 'groupId': 'BG002'}, {'value': '68.1', 'spread': '10.13', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnic Origin', 'categories': [{'title': 'African', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Caucasian', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-22', 'size': 1081813, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-23T03:57', 'hasProtocol': True}, {'date': '2019-06-10', 'size': 177701, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-23T05:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2012-07-16', 'resultsFirstSubmitDate': '2020-11-12', 'studyFirstSubmitQcDate': '2012-07-19', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-27', 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patients With Any Stroke or Transient Ischemic Attack (TIA)', 'timeFrame': '90 days after IMP application', 'description': 'patients with any stroke or TIA occuring within 90 days after IMP application.'}, {'measure': 'Major Bleedings', 'timeFrame': '90 days after IMP application', 'description': 'patients with major bleedings occuring within 90 days after IMP application'}, {'measure': 'Any Clinical Event', 'timeFrame': '365 days after IMP application', 'description': 'patients with any stroke \\& TIA, myocardial infarction \\& percutaneous coronary intervention (PCI), death or bleeding within one year (365 days) after IMP application.'}, {'measure': 'Anti-Drug Antibodies', 'timeFrame': '3 month (+/- 1 month) after IMP application', 'description': 'Anti-drug antibodies were measured at baseline and 3 month after IMP application.\n\nNumber of patients with positive anti-drug antibodies compared to baseline are counted.'}, {'measure': 'Participants With Adverse Events (AEs)', 'timeFrame': '~ 365 days after IMP application (whole study period)', 'description': 'All adverse events were assessed during complete study period (\\~ 1 year after IMP application).'}], 'primaryOutcomes': [{'measure': 'New DWI Lesion(s)', 'timeFrame': '1 day post intervention', 'description': 'The number of new diffusion weighted imaging (DWI) lesion(s) reported. (1 day after intervention compared to baseline).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Carotid Stenosis', 'Atherosclerosis', 'Stroke', 'Transient-ischaemic Attack', 'TIA', 'Amaurosis Fugax']}, 'referencesModule': {'references': [{'pmid': '20430036', 'type': 'BACKGROUND', 'citation': 'Bultmann A, Li Z, Wagner S, Peluso M, Schonberger T, Weis C, Konrad I, Stellos K, Massberg S, Nieswandt B, Gawaz M, Ungerer M, Munch G. Impact of glycoprotein VI and platelet adhesion on atherosclerosis--a possible role of fibronectin. J Mol Cell Cardiol. 2010 Sep;49(3):532-42. doi: 10.1016/j.yjmcc.2010.04.009. Epub 2010 Apr 27.'}, {'pmid': '9880390', 'type': 'BACKGROUND', 'citation': 'Goertler M, Baeumer M, Kross R, Blaser T, Lutze G, Jost S, Wallesch CW. Rapid decline of cerebral microemboli of arterial origin after intravenous acetylsalicylic acid. Stroke. 1999 Jan;30(1):66-9. doi: 10.1161/01.str.30.1.66.'}, {'pmid': '15851601', 'type': 'BACKGROUND', 'citation': 'Markus HS, Droste DW, Kaps M, Larrue V, Lees KR, Siebler M, Ringelstein EB. Dual antiplatelet therapy with clopidogrel and aspirin in symptomatic carotid stenosis evaluated using doppler embolic signal detection: the Clopidogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis (CARESS) trial. Circulation. 2005 May 3;111(17):2233-40. doi: 10.1161/01.CIR.0000163561.90680.1C. Epub 2005 Apr 25.'}, {'pmid': '14656994', 'type': 'BACKGROUND', 'citation': 'Massberg S, Konrad I, Bultmann A, Schulz C, Munch G, Peluso M, Lorenz M, Schneider S, Besta F, Muller I, Hu B, Langer H, Kremmer E, Rudelius M, Heinzmann U, Ungerer M, Gawaz M. Soluble glycoprotein VI dimer inhibits platelet adhesion and aggregation to the injured vessel wall in vivo. FASEB J. 2004 Feb;18(2):397-9. doi: 10.1096/fj.03-0464fje. Epub 2003 Dec 4.'}, {'pmid': '10390320', 'type': 'BACKGROUND', 'citation': 'Molloy J, Markus HS. Asymptomatic embolization predicts stroke and TIA risk in patients with carotid artery stenosis. Stroke. 1999 Jul;30(7):1440-3. doi: 10.1161/01.str.30.7.1440.'}, {'pmid': '12649139', 'type': 'BACKGROUND', 'citation': 'Nieswandt B, Watson SP. Platelet-collagen interaction: is GPVI the central receptor? Blood. 2003 Jul 15;102(2):449-61. doi: 10.1182/blood-2002-12-3882. Epub 2003 Mar 20.'}, {'pmid': '9506619', 'type': 'BACKGROUND', 'citation': 'Ringelstein EB, Droste DW, Babikian VL, Evans DH, Grosset DG, Kaps M, Markus HS, Russell D, Siebler M. Consensus on microembolus detection by TCD. International Consensus Group on Microembolus Detection. Stroke. 1998 Mar;29(3):725-9. doi: 10.1161/01.str.29.3.725.'}, {'pmid': '18566102', 'type': 'BACKGROUND', 'citation': 'Schonberger T, Siegel-Axel D, Bussl R, Richter S, Judenhofer MS, Haubner R, Reischl G, Klingel K, Munch G, Seizer P, Pichler BJ, Gawaz M. The immunoadhesin glycoprotein VI-Fc regulates arterial remodelling after mechanical injury in ApoE-/- mice. Cardiovasc Res. 2008 Oct 1;80(1):131-7. doi: 10.1093/cvr/cvn169. Epub 2008 Jun 19.'}, {'pmid': '21502572', 'type': 'BACKGROUND', 'citation': 'Ungerer M, Rosport K, Bultmann A, Piechatzek R, Uhland K, Schlieper P, Gawaz M, Munch G. Novel antiplatelet drug revacept (Dimeric Glycoprotein VI-Fc) specifically and efficiently inhibited collagen-induced platelet aggregation without affecting general hemostasis in humans. Circulation. 2011 May 3;123(17):1891-9. doi: 10.1161/CIRCULATIONAHA.110.980623. Epub 2011 Apr 18.'}, {'pmid': '26046734', 'type': 'BACKGROUND', 'citation': 'Jamasbi J, Megens RT, Bianchini M, Munch G, Ungerer M, Faussner A, Sherman S, Walker A, Goyal P, Jung S, Brandl R, Weber C, Lorenz R, Farndale R, Elia N, Siess W. Differential Inhibition of Human Atherosclerotic Plaque-Induced Platelet Activation by Dimeric GPVI-Fc and Anti-GPVI Antibodies: Functional and Imaging Studies. J Am Coll Cardiol. 2015 Jun 9;65(22):2404-15. doi: 10.1016/j.jacc.2015.03.573.'}, {'pmid': '26046735', 'type': 'BACKGROUND', 'citation': 'Kleiman NS, Kolandaivelu K. Expanding the Roster: Developing New Inhibitors of Intravascular Thrombosis. J Am Coll Cardiol. 2015 Jun 9;65(22):2416-9. doi: 10.1016/j.jacc.2015.03.576. No abstract available.'}, {'pmid': '35695006', 'type': 'DERIVED', 'citation': 'Uphaus T, Richards T, Weimar C, Neugebauer H, Poli S, Weissenborn K, Imray C, Michalski D, Rashid H, Loftus I, Rummey C, Ritter M, Hauser TK, Munch G, Groschel K, Poppert H. Revacept, an Inhibitor of Platelet Adhesion in Symptomatic Carotid Stenosis: A Multicenter Randomized Phase II Trial. Stroke. 2022 Sep;53(9):2718-2729. doi: 10.1161/STROKEAHA.121.037006. Epub 2022 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks (TIAs), amaurosis fugax or stroke receive either Revacept (single dose) plus antiplatelet monotherapy or monotherapy alone.\n\nPatients receive a single dose of trial medication by intravenous infusion for 20 minutes. Patients are followed up one and three days after treatment, at 3 months and by a telephone interview at 12 months.', 'detailedDescription': 'Patients had a more than 50% carotid artery stenosis according to ECST and suffered from ischemic stroke, transitory ischemic attack or intermittent blindness (amaurosis fugax) within the last 30 days. All patients were on standard medication with aspirin or clopidogrel and received heparin for thrombosis prophylaxis. Carotid endarterectomy (CEA), carotid stenting (CAS) or best medical therapy for treatment of the carotid stenosis and prevention of secondary thrombo-emboli was performed according to guidelines. Additional treatment with Revacept or placebo was done on top of the standard therapy. Therefore the control group receiving placebo was already on the standard medical therapy for patients with symptomatic carotid stenosis and received also the guideline conform interventions CEA, CAS or best medical therapy.\n\nSecondary prophylaxis of thrombo-embolic ischemic events by Revacept should be investigated. Therefore microemboli were detected by transcranial Doppler and ischemic brain lesions were investigated by diffusion weighted imaging magnetic resonance imaging (DWI-MRI) scan as exploratory endpoints. Moreover clinical endpoints such as stroke, TIA, myocardial infarction, coronary intervention and death were investigated at 1 week, 3 months and 12 months follow-up. Safety was closely monitored with emphasis on bleeding complications as bleeding is the most dreaded complication of anti-thrombotic agents especially in patients with cerebral strokes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written informed consent\n2. Target population\n\n * Diagnosis:\n\n * Extracranial carotid artery stenosis (diagnosed by vascular duplex ultrasound peak flow or angiography)\n * Lesions with ≥ 50 % stenosis according to the European Carotid Surgery Trial (ECST) criteria\n * TIA, amaurosis fugax or stroke within the last 30 days\n * Age and sex: Men and women aged \\> 18 years Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after receiving investigational product in such a manner that the risk of pregnancy is minimised.\n\nExclusion Criteria:\n\n1. Sex and reproductive Status:\n\n * WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product.\n * Women who are pregnant or breastfeeding\n * Women with a positive pregnancy test on enrollment or prior to investigational product administration.\n2. Target disease exceptions\n\n * NIHSS score \\> 18\n * Recent intracerebral haemorrhage by X-ray computed tomography (CT) or nuclear magnetic resonance (NMR)\n * Cardiac cause of embolisation (atrial fibrillation or other cardiac source e.g. artificial heart valves)\n3. Medical history and concurrent disease\n\n * History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation, hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug\n * History or evidence of thrombocytopenia (\\<30.000/ul), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thromboplastin time (aPTT))\n * Thrombolysis within the last 48 hours\n * Relevant haemorrhagic transformation as determined by CT, NMR or anamnesis\n * Oral anticoagulation or dual anti-platelet therapy with aspirin or clopidogrel and other P2Y inhibitors at screening (3 days for dipyridamole extended release; 8 hours for tirofiban/Aggrastat)\n * Sustained hypertension (systolic BP \\> 179 mmHg or diastolic BP \\>109 mmHg)\n * History of severe systemic disease such as terminal carcinoma, renal failure (or current creatinine \\> 200 umol/l), cirrhosis, severe dementia, or psychosis\n * Current severe liver dysfunction (transaminase level greater than 5-fold over upper normal range limit)\n * Active autoimmune disorder such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis or glomerulonephritis\n * Known atrial fibrillation or other clinically significant ECG abnormalities (at present)'}, 'identificationModule': {'nctId': 'NCT01645306', 'acronym': 'RevaceptCS02', 'briefTitle': 'Revacept in Symptomatic Carotid Stenosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AdvanceCor GmbH'}, 'officialTitle': 'Revacept, an Inhibitor of Platelet Adhesion in Symptomatic Carotid Stenosis: A Phase II, Multicentre; Randomised, Dose-finding, Double-blind and Placebo Controlled Superiority Study With Parallel Groups', 'orgStudyIdInfo': {'id': 'Revacept/CS/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol', 'description': 'Placebo control with PBS, 1% sucrose and 4% mannitol', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '40 mg Revacept', 'description': 'low dose Revacept 40mg in PBS, 1% sucrose, 4% mannitol', 'interventionNames': ['Drug: Revacept']}, {'type': 'ACTIVE_COMPARATOR', 'label': '120 mg Revacept', 'description': 'high dose revacept 120mg in PBS, 1% sucrose, 4% mannitol', 'interventionNames': ['Drug: Revacept']}], 'interventions': [{'name': 'Revacept', 'type': 'DRUG', 'otherNames': ['40 mg or 120 mg'], 'description': 'single intravenous injection', 'armGroupLabels': ['120 mg Revacept', '40 mg Revacept']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Control Group'], 'description': 'single intravenous injection', 'armGroupLabels': ['Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Site 01: Department of Neurology, TU Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Site 08: Universitätsklinikum Essen, Klinik für Neurologie', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Site 11: Universitätsklinikum Hamburg Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Site 07: Medizinische Hochschule Hannover, Klinik für Neurologie', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Site 12: Universitätsklinikum Leipzig AöR', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Site 09: Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Site 04: Universitätsklinikum Tübingen, Klinik für Allgemeine Neurologie', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Site 06: Universitätsklinikum Ulm, Abteilung für Neurologie', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Site 23 - University Hospital Coventry NHS Trust', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'NW1 2BU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Site 26 - University College London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 8AF', 'city': 'London', 'country': 'United Kingdom', 'facility': "Site 28 - King's College London Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 0QT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Site 20: St George's NHS Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Holger Poppert, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, TU Munich'}, {'name': 'Ian M Loftus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St George's NHS Trust"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdvanceCor GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}