Viewing Study NCT01429350

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 4:57 PM

Ignite Modification Date: 2026-01-31 @ 12:11 PM

Study NCT ID: NCT01429350

Status: COMPLETED

Last Update Posted: 2020-09-22

First Post: 2011-09-02

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: Assess the Penumbra System in the Treatment of Acute Stroke

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcorso@penumbrainc.com', 'phone': '510-995-2079', 'title': 'Michaella Corso', 'organization': 'Penumbra, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The number of participants are taken from the as-treated population.\n\nSerious Adverse Events: The number of participants are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.', 'eventGroups': [{'id': 'EG000', 'title': 'IV rtPA', 'description': 'IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg\n\nintravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg', 'otherNumAtRisk': 62, 'otherNumAffected': 58, 'seriousNumAtRisk': 62, 'seriousNumAffected': 32}, {'id': 'EG001', 'title': 'IV rtPA and IA Penumbra System', 'description': 'Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System\n\nPenumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device', 'otherNumAtRisk': 43, 'otherNumAffected': 42, 'seriousNumAtRisk': 43, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Aortic valve sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 10}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Diastolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Heart valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Left valve incomptence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Left atrial dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Mitral valve calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ventricular hypokinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders'}, {'term': 'Congenital cystic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hematesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Unevaluable event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Vessel puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Immune system disorders'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Clostridal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Eosophageal candiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Oral candiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Oral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 12}], 'organSystem': 'Infections and infestations'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Haematuria traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Incision site complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Incision site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Incision site hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Scrotal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Tongue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Antithrombin III decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Blood magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperchloraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypervolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypochloraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Vitamin B12 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Basal ganglia haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'Nervous system disorders'}, {'term': 'Carotid artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebral artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebral thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebrovascular spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Complex regional pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': "Dementia Alzheimer's type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 14}], 'organSystem': 'Nervous system disorders'}, {'term': 'Haemorrhagic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Haemorrhagic transformation stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hypertonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Intracranial pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Intraventricular haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Neurological decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Stroke in evolution', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Cystitis noninfective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Diaphragmatic hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 9}], 'organSystem': 'Vascular disorders'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Vascular calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Vasospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 7}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Haemorrhagic transformation stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Intraventricular haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Good Functional Outcome as Defined by a Modified Rankin Score of 0-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV rtPA', 'description': 'IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg\n\nintravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg'}, {'id': 'OG001', 'title': 'IV rtPA and IA Penumbra System', 'description': 'Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System\n\nPenumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'The assessor is blinded to patient treatment assignment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of All Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV rtPA', 'description': 'IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg\n\nintravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg'}, {'id': 'OG001', 'title': 'IV rtPA and IA Penumbra System', 'description': 'Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System\n\nPenumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'A Serious Adverse Event is defined as an event that:\n\n1. Led to death\n2. Led to a serious deterioration in the health of the patient that:\n\n * Resulted in life-threatening illness or injury\n * Resulted in permanent impairment of a body structure or a body function\n * Required in-patient hospitalization or prolongation of existing hospitalization\n * Resulted in medical or surgical intervention to arrest permanent impairment to body structure or a body function\n * Led to fetal distress, fetal death or a congenital abnormality or birth defect', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants here are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants started based on participant flow. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.'}, {'type': 'SECONDARY', 'title': 'Good Clinical Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV rtPA', 'description': 'IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg\n\nintravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg'}, {'id': 'OG001', 'title': 'IV rtPA and IA Penumbra System', 'description': 'Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System\n\nPenumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Good clinical outcome at 30 days post-procedure as defined by a 10 points or more improvement in the NIH stroke scale score at Discharge, a NIH stroke scale score of 0-1 at Discharge; or a 30-day modified Rankin scale score of 0-2', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '30 day good clinical outcome based on ITT (intent-to-treat) population.'}, {'type': 'SECONDARY', 'title': 'Incidence of Symptomatic and Asymptomatic Intracranial Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IV rtPA', 'description': 'IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg\n\nintravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg'}, {'id': 'OG001', 'title': 'IV rtPA and IA Penumbra System', 'description': 'Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System\n\nPenumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'A symptomatic intracranial hemorrhage is defined as 24 hour CT evidence of an ECASS defined ICH and a 4-point or more worsening of the NIH Stroke Scale score', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants here are taken from the as-treated population, where IV tPA alone is 62 which differs from the number of initial participants started based on participant flow. This is due to 9 subjects who were randomized to Penumbra System receiving IV tPA Alone and no Penumbra System was used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IV rtPA', 'description': 'IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg\n\nintravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg'}, {'id': 'FG001', 'title': 'IV rtPA and IA Penumbra System', 'description': 'Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System\n\nPenumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'As-Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Per Protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': '90 Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IV rtPA', 'description': 'IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg\n\nintravenous (IV) recombinant human tissue plasminogen activator (rtPA): 0.9mg/kg to a maximum of 90mg'}, {'id': 'BG001', 'title': 'IV rtPA and IA Penumbra System', 'description': 'Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System\n\nPenumbra System: The Penumbra System is an aspiration based mechanical thrombectomy device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '10', 'groupId': 'BG000'}, {'value': '67', 'spread': '11', 'groupId': 'BG001'}, {'value': '68.7', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2011-09-02', 'resultsFirstSubmitDate': '2019-03-04', 'studyFirstSubmitQcDate': '2011-09-06', 'lastUpdatePostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-18', 'studyFirstPostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Good Functional Outcome as Defined by a Modified Rankin Score of 0-2', 'timeFrame': '90 days', 'description': 'The assessor is blinded to patient treatment assignment.'}, {'measure': 'Incidence of All Serious Adverse Events', 'timeFrame': '90 days', 'description': 'A Serious Adverse Event is defined as an event that:\n\n1. Led to death\n2. Led to a serious deterioration in the health of the patient that:\n\n * Resulted in life-threatening illness or injury\n * Resulted in permanent impairment of a body structure or a body function\n * Required in-patient hospitalization or prolongation of existing hospitalization\n * Resulted in medical or surgical intervention to arrest permanent impairment to body structure or a body function\n * Led to fetal distress, fetal death or a congenital abnormality or birth defect'}], 'secondaryOutcomes': [{'measure': 'Good Clinical Outcome', 'timeFrame': '30 days', 'description': 'Good clinical outcome at 30 days post-procedure as defined by a 10 points or more improvement in the NIH stroke scale score at Discharge, a NIH stroke scale score of 0-1 at Discharge; or a 30-day modified Rankin scale score of 0-2'}, {'measure': 'Incidence of Symptomatic and Asymptomatic Intracranial Hemorrhage', 'timeFrame': '90 days', 'description': 'A symptomatic intracranial hemorrhage is defined as 24 hour CT evidence of an ECASS defined ICH and a 4-point or more worsening of the NIH Stroke Scale score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ischemic stroke', 'acute intervention', 'thrombolysis', 'rtPA', 'internal carotid artery', 'middle cerebral artery', 'mechanical thrombectomy', 'Penumbra System', 'clot length', 'mRS', 'NIHSS'], 'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '28596447', 'type': 'DERIVED', 'citation': 'Yoo AJ, Khatri P, Mocco J, Zaidat OO, Gupta R, Frei D, Lopes D, Shownkeen H, Berkhemer OA, Meyer D, Hak SS, Kuo SS, Buell H, Bose A, Sit SP, von Kummer R; THERAPY Trial Investigators. Impact of Thrombus Length on Outcomes After Intra-Arterial Aspiration Thrombectomy in the THERAPY Trial. Stroke. 2017 Jul;48(7):1895-1900. doi: 10.1161/STROKEAHA.116.016253. Epub 2017 Jun 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the brain. IV rtPA is the only drug approved for the treatment of acute ischemic stroke but it does not work very well in cases where the stroke is caused by a large vessel occlusion. The hypothesis being tested is to determine if the addition of a treatment by a mechanical thrombectomy device like the Penumbra System can improve the clinical outcome of the patient over just using IV rtPA alone.', 'detailedDescription': 'Current therapies for acute stroke are limited to the intravenous administration of a intravenous (IV) recombinant human tissue plasminogen activator (rtPA) for thrombolysis of the affected cerebral arteries within 3-4.5 hours from symptom onset, and the use of intra-arterial (IA) endovascular mechanical clot retrieval devices within 8 hours from ictus, all of which have limitations as mono therapies. For example, IV rtPA may not be very efficacious in large vessel occlusion and the long term effects of mechanical thrombectomy devices on patient functional outcome is unknown. This is a randomized, concurrent controlled study to assess the safety and effectiveness of the Penumbra System as adjunctive therapy to IV rtPA in the acute intervention of acute ischemic stroke. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large clot burden (clot length \\> 8mm) in the anterior circulation will be assigned to either IV rtPA therapy alone (0.9mg/kg to a maximum of 90mg) or a combined IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and intra-arterial (IA) adjunctive treatment with the Penumbra System. Each treated patient will be followed and assessed for 3 months after enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. From 18 to 85 years of age\n2. Present with symptoms consistent with an acute ischemic stroke and eligible for IV rtPA therapy (patients presenting 3-4.5 hrs from symptom onset are not eligible if they are \\>80 yrs of age, have a history of stroke and diabetes, anticoagulant use (even if INR is \\<1.7) and have a NIHSS score \\>25\n3. Evidence of a large vessel occlusion in the anterior circulation with a clot length of 8mm or longer\n4. NIH Stroke Scale (NIHSS) score 8 or greater or aphasic at presentation\n5. Signed informed consent\n\nExclusion Criteria:\n\n1. History of stroke in the past 3 months.\n2. Females who are pregnant\n3. Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score 1 or greater\n4. Known severe allergy to contrast media\n5. Uncontrolled hypertension (defined as systolic blood pressure \\>185 mmHg or diastolic blood pressure \\>110 mmHg)\n6. CT evidence of the following conditions at randomization:\n\n * Significant mass effect with midline shift\n * Any acute ischemic changes in \\>1/3 of the affected middle cerebral artery territory\n * Evidence of intracranial hemorrhage\n7. Angiographic evidence of tantem extracranial occlusion or an arterial stenosis proximal to the occlusion that requires treatment prior to thrombus removal. Moderate stenosis not requiring treatment is not an exclusion\n8. Angiographic evidence of preexisting arterial injury\n9. Rapidly improving neurological status prior to randomization\n10. Bilateral stroke\n11. Intracranial tumors\n12. Known history of cerebral aneurysm or arteriovenous malfunction\n13. Known hemorrhagic diathesis, coagulation deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of \\>1.7\n14. Baseline platelets \\<50,000\n15. Use of IV heparin in the past 48 hours with PPT \\>1.5 times the normalized ratio\n16. Pre-treatment glucose \\<50mg/dL or \\>300mg/dL\n17. Life expectancy less than 90 days prior to stroke onset\n18. Participation in another clinical investigation that could confound the evaluation of the study device'}, 'identificationModule': {'nctId': 'NCT01429350', 'acronym': 'THERAPY', 'briefTitle': 'Assess the Penumbra System in the Treatment of Acute Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Penumbra Inc.'}, 'officialTitle': "The THERAPY Trial: The Randomized, Concurrent Controlled Trial to Assess the Penumbra System's Safety and Effectiveness in the Treatment of Acute Stroke", 'orgStudyIdInfo': {'id': 'CLP 4338'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IV rtPA', 'description': 'IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg', 'interventionNames': ['Drug: intravenous (IV) recombinant human tissue plasminogen activator (rtPA)']}, {'type': 'EXPERIMENTAL', 'label': 'IV rtPA and IA Penumbra System', 'description': 'Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System', 'interventionNames': ['Device: Penumbra System']}], 'interventions': [{'name': 'intravenous (IV) recombinant human tissue plasminogen activator (rtPA)', 'type': 'DRUG', 'otherNames': ['recombinant tissue plasminogen activator, Alteplase'], 'description': '0.9mg/kg to a maximum of 90mg', 'armGroupLabels': ['IV rtPA']}, {'name': 'Penumbra System', 'type': 'DEVICE', 'description': 'The Penumbra System is an aspiration based mechanical thrombectomy device', 'armGroupLabels': ['IV rtPA and IA Penumbra System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80112', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Endovascular Surgical Neuroradiology, Swedish Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Department of Neurological Surgery', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Neurosurgery, Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'J Mocco, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Pooja Khatri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, University of Cincinnati'}, {'name': 'Osama Zaidat, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurointerventional Program, Medical College of Wisconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penumbra Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}