Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT00059332
Status:
COMPLETED
Last Update Posted:
2015-08-21
First Post:
2003-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jsaver@mednet.ucla.edu', 'phone': '310-794-6379', 'title': 'Dr. Jeffrey Saver', 'organization': 'UCLA, David Geffen School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months after stroke onset', 'description': 'A serious adverse event is one that is fatal or life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or is a congenital anomaly, cancer or medication overdose, or any event that the treating clinician judges to be a significant hazard, contraindication, side effect, or precaution.', 'eventGroups': [{'id': 'EG000', 'title': 'Normal Saline', 'description': 'Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.', 'otherNumAtRisk': 843, 'otherNumAffected': 331, 'seriousNumAtRisk': 843, 'seriousNumAffected': 422}, {'id': 'EG001', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.', 'otherNumAtRisk': 857, 'otherNumAffected': 329, 'seriousNumAtRisk': 857, 'seriousNumAffected': 439}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numEvents': 173, 'numAffected': 167}, {'groupId': 'EG001', 'numAtRisk': 857, 'numEvents': 184, 'numAffected': 178}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numEvents': 233, 'numAffected': 214}, {'groupId': 'EG001', 'numAtRisk': 857, 'numEvents': 217, 'numAffected': 205}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numEvents': 142, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 857, 'numEvents': 152, 'numAffected': 138}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 43}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 28}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 21}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pericardial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Torsade de pointes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retroperitoneal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pelvic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 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2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain neoplasm 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'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Maxillofacial sinus neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Parathyroid tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Primitive neuroectodermal tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Complicated migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 7}], 'organSystem': 'Nervous system 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'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 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'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nephritis interstitial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory failure', 'stats': 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'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 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'numAtRisk': 843, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endotracheal intubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haematoma evacuation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung lobectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Medical device implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mitral valve replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ventricular drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carotid artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 36}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 59}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neurogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vasospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 843, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 857, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Modified Rankin Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '857', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline', 'description': 'Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.'}, {'id': 'OG001', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'ONE_SIDED', 'groupDescription': 'For the primary efficacy analysis, data were analyzed to test the null hypothesis that the distribution of scores over all 7 levels of the modified Rankin Scale at Day 90 was identical in the magnesium sulfate and placebo groups, vs. the one-sided alternative that the distribution of scores is shifted lower in the active magnesium sulfate therapy group. The statistic used to test the primary hypothesis was the Cochran-Mantel-Haenszel test statistic stratified by transport vehicle.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '3 months after stroke onset', 'description': 'Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes.\n\n0 No symptoms at all\n\n1. No significant disability despite symptoms; able to carry out all usual duties and activities\n2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance\n3. Moderate disability; requiring some help, but able to walk without assistance\n4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance\n5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention\n6. Dead', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Rankin Score of 0 or 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '857', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline', 'description': 'Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.'}, {'id': 'OG001', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '311', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.20', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Minimal or no disability based on the modified Rankin score', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Rankin Score ≤2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '857', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline', 'description': 'Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.'}, {'id': 'OG001', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '445', 'groupId': 'OG000'}, {'value': '449', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.19', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Functional independence based on modified Rankin score', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'NIH Stroke Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '857', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline', 'description': 'Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.'}, {'id': 'OG001', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '42'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '19'}]}]}], 'analyses': [{'pValue': '0.2760', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are:\n\n1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Barthel Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '857', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline', 'description': 'Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.'}, {'id': 'OG001', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '100'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.3912', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'The Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are:\n\nFEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stroke Impact Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '857', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline', 'description': 'Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.'}, {'id': 'OG001', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '91.7'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '91.7'}]}]}], 'analyses': [{'pValue': '0.3230', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'The Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes.\n\n1. Physical problems\n2. Memory and thinking\n3. Mood and emotions\n4. Communication, reading and understanding\n5. Daily activities\n6. Mobility at home and in the community\n7. Affected hand use\n8. Hobbies and activities participation', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '857', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline', 'description': 'Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.'}, {'id': 'OG001', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '422', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.95', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.27', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptomatic Intracranial Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '857', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline', 'description': 'Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.'}, {'id': 'OG001', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.14', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 month', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'OG000'}, {'value': '857', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Saline', 'description': 'Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.'}, {'id': 'OG001', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.95', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.29', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Saline', 'description': 'Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.'}, {'id': 'FG001', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '843'}, {'groupId': 'FG001', 'numSubjects': '857'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '840'}, {'groupId': 'FG001', 'numSubjects': '855'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '843', 'groupId': 'BG000'}, {'value': '857', 'groupId': 'BG001'}, {'value': '1700', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Saline', 'description': 'Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.'}, {'id': 'BG001', 'title': 'Magnesium Sulfate', 'description': 'Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '69', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '69', 'spread': '13.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<60 years of age', 'categories': [{'measurements': [{'value': '239', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}]}, {'title': '60-75 years of age', 'categories': [{'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '562', 'groupId': 'BG002'}]}]}, {'title': '>75 years of age', 'categories': [{'measurements': [{'value': '320', 'groupId': 'BG000'}, {'value': '337', 'groupId': 'BG001'}, {'value': '657', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '367', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '725', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '476', 'groupId': 'BG000'}, {'value': '499', 'groupId': 'BG001'}, {'value': '975', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '637', 'groupId': 'BG000'}, {'value': '661', 'groupId': 'BG001'}, {'value': '1298', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '661', 'groupId': 'BG000'}, {'value': '664', 'groupId': 'BG001'}, {'value': '1325', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Medical History', 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '648', 'groupId': 'BG000'}, {'value': '671', 'groupId': 'BG001'}, {'value': '1319', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes', 'categories': [{'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '377', 'groupId': 'BG002'}]}]}, {'title': 'Hyperlipidimia', 'categories': [{'measurements': [{'value': '407', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '805', 'groupId': 'BG002'}]}]}, {'title': 'Atrial fibrillation', 'categories': [{'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}]}, {'title': 'Myocardial infarction', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}]}, {'title': 'Tobacco use', 'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}]}, {'title': 'Alcohol use', 'categories': [{'measurements': [{'value': '328', 'groupId': 'BG000'}, {'value': '326', 'groupId': 'BG001'}, {'value': '654', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prestroke function - Living at home', 'classes': [{'categories': [{'measurements': [{'value': '823', 'groupId': 'BG000'}, {'value': '834', 'groupId': 'BG001'}, {'value': '1657', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Los Angeles Motor Scale at hospital arrival', 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '3.4', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '2.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Los Angeles Motor Scale (LAMS) Facial droop (sub score is 0-1) Absent 0 Present 1 Arm drift (sub score range is 0-2) Absent 0 Drifts down 1 Falls rapidly 2 Grip strength (sub score range is 0-2) Normal 0 Weak grip 1 No grip 2 The sub scales are summed to obtain a total score. Total Score Range is 0-5. Lower values on the scale represent better outcomes and Higher values on the scale represent worse outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'National Institute of Health Stroke Scale (NIHSS) at hospital arrival', 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '11.5', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '11.3', 'spread': '9.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are:\n\n1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Intravenous tissue plasminogen activator (t-PA) in patients with cerebral ischemia', 'classes': [{'categories': [{'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Final Diagnosis', 'classes': [{'title': 'Cerebral Ischemia', 'categories': [{'measurements': [{'value': '613', 'groupId': 'BG000'}, {'value': '632', 'groupId': 'BG001'}, {'value': '1245', 'groupId': 'BG002'}]}]}, {'title': 'Intracranial Hemorrhage', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}]}, {'title': 'Cerebrovascular-mimicking condition', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-24', 'studyFirstSubmitDate': '2003-04-23', 'resultsFirstSubmitDate': '2015-06-09', 'studyFirstSubmitQcDate': '2003-04-23', 'lastUpdatePostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-24', 'studyFirstPostDateStruct': {'date': '2003-04-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Rankin Scale', 'timeFrame': '3 months after stroke onset', 'description': 'Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes.\n\n0 No symptoms at all\n\n1. No significant disability despite symptoms; able to carry out all usual duties and activities\n2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance\n3. Moderate disability; requiring some help, but able to walk without assistance\n4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance\n5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention\n6. Dead'}], 'secondaryOutcomes': [{'measure': 'Modified Rankin Score of 0 or 1', 'timeFrame': '3 months', 'description': 'Minimal or no disability based on the modified Rankin score'}, {'measure': 'Modified Rankin Score ≤2', 'timeFrame': '3 months', 'description': 'Functional independence based on modified Rankin score'}, {'measure': 'NIH Stroke Scale', 'timeFrame': '3 months', 'description': 'The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are:\n\n1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention'}, {'measure': 'Barthel Index', 'timeFrame': '3 months', 'description': 'The Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are:\n\nFEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10)'}, {'measure': 'Stroke Impact Scale', 'timeFrame': '3 months', 'description': 'The Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes.\n\n1. Physical problems\n2. Memory and thinking\n3. Mood and emotions\n4. Communication, reading and understanding\n5. Daily activities\n6. Mobility at home and in the community\n7. Affected hand use\n8. Hobbies and activities participation'}, {'measure': 'Serious Adverse Events', 'timeFrame': '3 months'}, {'measure': 'Symptomatic Intracranial Hemorrhage', 'timeFrame': '3 month'}, {'measure': 'Mortality', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stroke', 'brain attack', 'magnesium sulfate', 'neuroprotection', 'prehospital care', 'emergency medical services'], 'conditions': ['Cerebrovascular Accident']}, 'referencesModule': {'references': [{'pmid': '39011360', 'type': 'DERIVED', 'citation': 'Kazaryan SA, Shkirkova K, Saver JL, Liebeskind DS, Starkman S, Bulic S, Poblete R, Kim-Tenser M, Guo S, Conwit R, Villablanca P, Hamilton S, Sanossian N. The National Institutes of Health Stroke Scale is comparable to the ICH score in predicting outcomes in spontaneous acute intracerebral hemorrhage. Front Neurol. 2024 Jul 1;15:1401793. doi: 10.3389/fneur.2024.1401793. eCollection 2024.'}, {'pmid': '38126183', 'type': 'DERIVED', 'citation': 'Liotta EM, Maas MB, Prabhakaran S, Shkirkova K, Sanossian N, Liebeskind DS, Sharma L, Stratton S, Conwit R, Saver JL; FAST-MAG Investigators and Coordinators. Magnesium and Hematoma Expansion in Intracerebral Hemorrhage: A FAST-MAG Randomized Trial Analysis. Stroke. 2024 Feb;55(2):463-466. doi: 10.1161/STROKEAHA.123.043555. Epub 2023 Dec 21.'}, {'pmid': '36878722', 'type': 'DERIVED', 'citation': 'Balucani C, Levine SR, Sanossian N, Starkman S, Liebeskind D, Gornbein JA, Shkirkova K, Stratton S, Eckstein M, Hamilton S, Conwit R, Sharma LK, Saver JL. Neurologic Improvement in Acute Cerebral Ischemia: Frequency, Magnitude, Predictors, and Clinical Outcomes. Neurology. 2023 Mar 7;100(10):e1038-e1047. doi: 10.1212/WNL.0000000000201656. Epub 2022 Dec 7.'}, {'pmid': '36599321', 'type': 'DERIVED', 'citation': 'Fan S, Jang M, Kim-Tenser M, Shkirkova K, Liebeskind DS, Starkman S, Villablanca JP, Hamilton S, Naidech A, Saver JL, Sanossian N; FAST-MAG Investigators and Coordinators. Effect of Magnesium on Deterioration and Symptomatic Hemorrhagic Transformation in Cerebral Ischemia: An Ancillary Analysis of the FAST-MAG Trial. Cerebrovasc Dis. 2023;52(5):539-542. doi: 10.1159/000528385. Epub 2023 Jan 4.'}, {'pmid': '35380053', 'type': 'DERIVED', 'citation': 'Naidech AM, Shkirkova K, Villablanca JP, Sanossian N, Liebeskind DS, Sharma L, Eckstein M, Stratton S, Conwit R, Hamilton S, Saver JL; FAST-MAG Investigators and Coordinators. Magnesium Sulfate and Hematoma Expansion: An Ancillary Analysis of the FAST-MAG Randomized Trial. Stroke. 2022 May;53(5):1516-1519. doi: 10.1161/STROKEAHA.121.037999. Epub 2022 Apr 5.'}, {'pmid': '32038463', 'type': 'DERIVED', 'citation': 'Shkirkova K, Wang TT, Vartanyan L, Liebeskind DS, Eckstein M, Starkman S, Stratton S, Pratt FD, Hamilton S, Kim-Tenser M, Conwit R, Saver JL, Sanossian N. Quality of Acute Stroke Care at Primary Stroke Centers Before and After Certification in Comparison to Never-Certified Hospitals. Front Neurol. 2020 Jan 22;10:1396. doi: 10.3389/fneur.2019.01396. eCollection 2019.'}, {'pmid': '31955642', 'type': 'DERIVED', 'citation': 'Shkirkova K, Schuberg S, Balouzian E, Starkman S, Eckstein M, Stratton S, Pratt FD, Hamilton S, Sharma L, Liebeskind DS, Conwit R, Saver JL, Sanossian N; FAST-MAG Investigators and Coordinators. Paramedic Global Impression of Change During Prehospital Evaluation and Transport for Acute Stroke. Stroke. 2020 Mar;51(3):784-791. doi: 10.1161/STROKEAHA.119.026392. Epub 2020 Jan 20.'}, {'pmid': '30039165', 'type': 'DERIVED', 'citation': 'Shkirkova K, Saver JL, Starkman S, Wong G, Weng J, Hamilton S, Liebeskind DS, Eckstein M, Stratton S, Pratt F, Conwit R, Sanossian N; FAST-MAG Trial Coordinators and Investigators. Frequency, Predictors, and Outcomes of Prehospital and Early Postarrival Neurological Deterioration in Acute Stroke: Exploratory Analysis of the FAST-MAG Randomized Clinical Trial. JAMA Neurol. 2018 Nov 1;75(11):1364-1374. doi: 10.1001/jamaneurol.2018.1893.'}, {'pmid': '29301973', 'type': 'DERIVED', 'citation': 'Chung PW, Kim JT, Sanossian N, Starkmann S, Hamilton S, Gornbein J, Conwit R, Eckstein M, Pratt F, Stratton S, Liebeskind DS, Saver JL; FAST-MAG Investigators and Coordinators. Association Between Hyperacute Stage Blood Pressure Variability and Outcome in Patients With Spontaneous Intracerebral Hemorrhage. Stroke. 2018 Feb;49(2):348-354. doi: 10.1161/STROKEAHA.117.017701. Epub 2018 Jan 4.'}, {'pmid': '28389617', 'type': 'DERIVED', 'citation': 'Sanossian N, Rosenberg L, Liebeskind DS, Starkman S, Eckstein M, Stratton S, Pratt FD, Hamilton S, Kim-Tenser M, Sharma LK, Restrepo L, Valdes-Suieras M, Conwit R, Saver JL; FAST-MAG Investigators and Coordinators. A Dedicated Spanish Language Line Increases Enrollment of Hispanics Into Prehospital Clinical Research. Stroke. 2017 May;48(5):1389-1391. doi: 10.1161/STROKEAHA.117.014745. Epub 2017 Apr 7.'}, {'pmid': '27679533', 'type': 'DERIVED', 'citation': 'Sanossian N, Apibunyopas KC, Liebeskind DS, Starkman S, Burgos AM, Conwit R, Eckstein M, Pratt F, Stratton S, Hamilton S, Saver JL; FAST-MAG (Field Administration of Stroke Therapy-Magnesium) Investigators and Coordinators. Characteristics and Outcomes of Very Elderly Enrolled in a Prehospital Stroke Research Study. Stroke. 2016 Nov;47(11):2737-2741. doi: 10.1161/STROKEAHA.116.013318. Epub 2016 Sep 27.'}, {'pmid': '26658446', 'type': 'DERIVED', 'citation': 'Kim DH, Saver JL, Starkman S, Liebeskind DS, Ali LK, Restrepo L, Kim-Tenser M, Valdes-Sueiras M, Eckstein M, Pratt F, Stratton S, Hamilton S, Conwit R, Sanossian N; Field Administration of Stroke Therapy-Magnesium (FAST-MAG) Trial Nurse-Coordinators and Investigators. Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial. Stroke. 2016 Jan;47(1):232-5. doi: 10.1161/STROKEAHA.115.011687. Epub 2015 Dec 10.'}, {'pmid': '26265130', 'type': 'DERIVED', 'citation': 'Sanossian N, Liebeskind DS, Eckstein M, Starkman S, Stratton S, Pratt FD, Koenig W, Hamilton S, Kim-Tenser M, Conwit R, Saver JL; FAST-MAG Investigators and Coordinators. Routing Ambulances to Designated Centers Increases Access to Stroke Center Care and Enrollment in Prehospital Research. Stroke. 2015 Oct;46(10):2886-90. doi: 10.1161/STROKEAHA.115.010264. Epub 2015 Aug 11.'}, {'pmid': '25651247', 'type': 'DERIVED', 'citation': 'Saver JL, Starkman S, Eckstein M, Stratton SJ, Pratt FD, Hamilton S, Conwit R, Liebeskind DS, Sung G, Kramer I, Moreau G, Goldweber R, Sanossian N; FAST-MAG Investigators and Coordinators. Prehospital use of magnesium sulfate as neuroprotection in acute stroke. N Engl J Med. 2015 Feb 5;372(6):528-36. doi: 10.1056/NEJMoa1408827.'}], 'seeAlsoLinks': [{'url': 'http://www.fastmag.info', 'label': 'The official FAST-MAG Clinical Trial website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the effectiveness and safety of field-initiated magnesium sulfate in improving the long-term functional outcome of patients with acute stroke.', 'detailedDescription': 'Stroke is the third leading cause of death and the leading cause of adult disability in the United States. Each year, more than 750,000 Americans suffer a symptomatic stroke.\n\nCurrently, tissue plasminogen activator (rt-PA) is the only approved treatment for acute ischemic stroke; however, its usefulness is limited because most patients cannot reach medical attention within the necessary 3-hour time window. In addition, rt-PA cannot be given in the field because it is contraindicated for treatment of patients with brain hemorrhage.\n\nThe purpose of this multi-center, randomized, double-blind trial is to demonstrate that paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an effective and safe treatment for acute stroke. This study will analyze magnesium sulfate, an experimental therapy for stroke, versus placebo among ambulance-transported patients with acute stroke. This trial will also demonstrate that paramedics can safely, effectively, and rapidly start neuroprotective therapies for stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected stroke identified by the Los Angeles Prehospital Stroke Screen\n* Age 40-95, inclusive\n* Last known well time within 2 hours of treatment initiation\n* Deficit present for \\>/= 15 minutes\n\nExclusion Criteria:\n\n* Coma\n* Rapidly improving neurologic deficit\n* Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations\n* Systolic Blood Pressure (SBP) \\< 90 or \\> 220\n* Known severe renal dysfunction (on dialysis or known chronic creatinine \\> 3.0)\n* Severe respiratory distress (O2 sat \\< 90% or respiratory rate \\< 12 or \\>/= 24)\n* Known second or third degree heart block with no pacemaker in place\n* Major head trauma in the last 24 hours\n* Recent stroke within prior 30 days\n* Patient unable to give informed consent and no available on scene consent or assent provider'}, 'identificationModule': {'nctId': 'NCT00059332', 'acronym': 'FAST-MAG', 'briefTitle': 'Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Field Administration of Stroke Therapy-Magnesium Trial: A Randomized, Double-Blind, Placebo Controlled Trial of Neuroprotective Magnesium Sulfate Therapy for Acute Stroke Initiated Within 2 Hours of Onset by Paramedics in the Field', 'orgStudyIdInfo': {'id': 'U01NS044364', 'link': 'https://reporter.nih.gov/quickSearch/U01NS044364', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U01NS044364', 'link': 'https://reporter.nih.gov/quickSearch/U01NS044364', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium Sulfate', 'description': 'Magnesium sulfate (Mg) was administered intravenously with a 15 minute bolus load followed by a 24 hour infusion. The bolus-loading dose consisted of 4 grams Mg in 54 ml normal saline. The maintenance infusion contained 16 grams Mg diluted in 240 ml 0.9% normal saline, infused at 10 ml/hr for 24 hours. Paramedics in the field initiated the bolus-loading dose, administered at 216 ml/hr over 15 minutes through a rate controlled IV infusion set. The maintenance infusion was initiated in hospital immediately upon completion of the loading dose.', 'interventionNames': ['Drug: Magnesium Sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'Normal saline was administered intravenously with a 15 minute bolus load followed by a 24 hour infusion. Paramedics in the field initiated the bolus-loading dose of 54 ml normal saline, administered at 216 ml/hr over 15 minutes through a rate controlled IV infusion set. The maintenance infusion was initiated in hospital immediately upon completion of the loading dose at 10 ml/hr for 24 hours.', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Magnesium Sulfate', 'type': 'DRUG', 'otherNames': ['MA 135 magnesium sulfate heptahydrate'], 'description': 'Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.', 'armGroupLabels': ['Magnesium Sulfate']}, {'name': 'Normal Saline', 'type': 'DRUG', 'otherNames': ['SO155 sodium chloride'], 'description': 'Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Jeffrey Saver, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA School of Medicine, Study Overall Principal Investigator'}, {'name': 'Sidney Starkman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA Stroke Center, Co-Principal Investigator'}, {'name': 'Marc Eckstein, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Los Angeles City Emergency Medical Service, Co-Principal Investigator'}, {'name': 'Samuel Stratton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Los Angeles and Orange County Emergency Medical Services Agencies, Co-Principal Investigator'}, {'name': 'Frank Pratt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Los Angeles County Emergency Medical Service, Co-Principal Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeffrey L. Saver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology', 'investigatorFullName': 'Jeffrey L. Saver', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}