Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-26 @ 5:51 PM
Study NCT ID:
NCT02930018
Status:
COMPLETED
Last Update Posted:
2022-10-10
First Post:
2016-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Nerinetide (NA-1) in Subjects Undergoing Endovascular Thrombectomy for Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mtymianski@nonoinc.ca', 'phone': '4165831687', 'title': 'Michael Tymianski, MD PhD', 'organization': 'NoNO Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events occurring within 30 days of randomization and all Serious Adverse Events up to the end of study visit (Day 90 visit or death) or until the subject was deemed "lost to follow-up" were reported.', 'description': 'All Adverse Events (Serious and Non-Serious) were monitored for the Safety Population, which included all subjects who received any amount of study drug (total of 1101 subjects).\n\nAdverse Events of Special Interest (AESI) were also collected, and included any Adverse Event which occurred within 2 hours of end of drug infusion and which fall under the standardized MedDRA queries of "Angioedema", "Anaphylactic reaction", "Anaphylactic shock" and terms relating to "hypotension".', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Drug vehicle only\n\nPlacebo: Placebo Comparator: Placebo', 'otherNumAtRisk': 554, 'deathsNumAtRisk': 556, 'otherNumAffected': 472, 'seriousNumAtRisk': 554, 'deathsNumAffected': 74, 'seriousNumAffected': 198}, {'id': 'EG001', 'title': 'Nerinetide, 2.6 mg/kg', 'description': 'Single intravenous infusion of nerinetide over 10 ± 1 minutes', 'otherNumAtRisk': 547, 'deathsNumAtRisk': 549, 'otherNumAffected': 474, 'seriousNumAtRisk': 547, 'deathsNumAffected': 64, 'seriousNumAffected': 181}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 79}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hemorrhagic Transformation Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 60}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 60}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vascular procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 49}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 48}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 35}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vessel puncture site hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stroke In Evolution', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mitral valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinus arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peritoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vascular stent occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vessel puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vessel puncture site occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac valve abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac valve vegetation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stoma site abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebral hyperperfusion syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Endotracheal intubation complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrostomy tube site complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Reocclusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Traumatic intracranial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vascular access site pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vascular procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatic enzyme abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cervix cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Non-small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Small intestine adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Carotid arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemorrhagic transformation stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lacunar stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neurological decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stroke in evolution', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vascular dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Post stroke depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Choking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Loss of personal independence in daily activities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Left atrial appendage occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Brachiocephalic vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 554, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 547, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With mRS Score of 0 to 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}, {'value': '549', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug vehicle only\n\nPlacebo: Placebo Comparator: Placebo'}, {'id': 'OG001', 'title': 'Nerinetide, 2.6 mg/kg', 'description': 'Single intravenous infusion of nerinetide over 10 ± 1 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '329', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.335', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.146', 'ciLowerLimit': '0.869', 'ciUpperLimit': '1.511', 'pValueComment': '2 sided 0.05 significance level.', 'groupDescription': 'The primary hypothesis was that administration of nerinetide (NA-1) would result in an increase in the proportion of responders. The primary analysis was a Wald test for treatment group difference in the primary outcome from a logistic regression adjusted for the 2 stratification variables (alteplase use, first declared thrombectomy device), and the 6 covariates used in the minimization. The trial was designed to have 80% power to detect an 8.7% absolute difference between groups.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS (Acute Ischemic Stroke) patients with prior administration of alteplase as part of standard-of-care.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 Days', 'description': 'Overall number of subjects experiencing a favorable functional outcome 90 days post-randomization, defined as 0 to 2 on the mRS.\n\nThe modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With NIHSS Score of 0 to 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}, {'value': '549', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug vehicle only\n\nPlacebo: Placebo Comparator: Placebo'}, {'id': 'OG001', 'title': 'Nerinetide, 2.6 mg/kg', 'description': 'Single intravenous infusion of nerinetide over 10 ± 1 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '320', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.866', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.024', 'ciLowerLimit': '0.781', 'ciUpperLimit': '1.342', 'pValueComment': '2 sided 0.05 significance level.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 Days or the last rating', 'description': 'Number of subjects with good neurological outcome, as defined by a score of 0 to 2 on the NIHSS at Day 90 or the last rating.\n\nThe National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating increasing severity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}, {'value': '549', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug vehicle only\n\nPlacebo: Placebo Comparator: Placebo'}, {'id': 'OG001', 'title': 'Nerinetide, 2.6 mg/kg', 'description': 'Single intravenous infusion of nerinetide over 10 ± 1 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.199', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.776', 'ciLowerLimit': '0.527', 'ciUpperLimit': '1.143', 'pValueComment': '2 sided 0.05 significance level.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 Days', 'description': 'Mortality rate, as defined by event rate (%) for mortality over the 90-day study period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Number of Subjects With mRS Score of 0 to 2 in the No-alteplase Sub-group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug vehicle only\n\nPlacebo: Placebo Comparator: Placebo'}, {'id': 'OG001', 'title': 'Nerinetide, 2.6 mg/kg', 'description': 'Single intravenous infusion of nerinetide over 10 ± 1 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.657', 'ciLowerLimit': '1.055', 'ciUpperLimit': '2.603', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute Risk Difference (%)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '9.6', 'estimateComment': 'The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk Difference (%)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '19.3', 'estimateComment': 'The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Overall number of subjects experiencing a favorable functional outcome 90 days post-randomization, defined as 0 to 2 on the mRS in the sub-group of participants not treated with alteplase as part of standard-of-care.\n\nThe modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Number of Subjects With NIHSS Score of 0 to 2 in the No-Alteplase Sub-group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug vehicle only\n\nPlacebo: Placebo Comparator: Placebo'}, {'id': 'OG001', 'title': 'Nerinetide, 2.6 mg/kg', 'description': 'Single intravenous infusion of nerinetide over 10 ± 1 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.088', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.482', 'ciLowerLimit': '0.943', 'ciUpperLimit': '2.329', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute Risk Difference (%)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '9.1', 'estimateComment': 'The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk Difference (%)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '18.3', 'estimateComment': 'The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days or last rating', 'description': 'Number of subjects with good neurological outcome, as defined by a score of 0 to 2 on the NIHSS at Day 90 or the last rating in the sub-group of participants not treated with alteplase as part of standard-of-care.\n\nThe National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating increasing severity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Mortality Rate in the No-Alteplase Sub-group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug vehicle only\n\nPlacebo: Placebo Comparator: Placebo'}, {'id': 'OG001', 'title': 'Nerinetide, 2.6 mg/kg', 'description': 'Single intravenous infusion of nerinetide over 10 ± 1 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.572', 'ciLowerLimit': '0.323', 'ciUpperLimit': '1.013', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Absolute Risk Difference (%)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '7.5', 'estimateComment': 'The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk Difference (%)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '39.7', 'estimateComment': 'The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Mortality rate, as defined by event rate (%) for mortality over the 90-day study period in the sub-group of participants not treated with alteplase as part of standard-of-care', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Number of Subjects With mRS Score of 0 to 2 in the Alteplase Sub-group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug vehicle only\n\nPlacebo: Placebo Comparator: Placebo'}, {'id': 'OG001', 'title': 'Nerinetide, 2.6 mg/kg', 'description': 'Single intravenous infusion of nerinetide over 10 ± 1 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.529', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.887', 'ciLowerLimit': '0.612', 'ciUpperLimit': '1.286', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Overall proportion of subjects experiencing a favorable functional outcome 90 days post-randomization, defined as 0 to 2 on the mRS in the sub-group of participants treated with alteplase as part of standard-of-care.\n\nThe modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Number of Subjects With NIHSS Score of 0 to 2 in the Alteplase Sub-group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug vehicle only\n\nPlacebo: Placebo Comparator: Placebo'}, {'id': 'OG001', 'title': 'Nerinetide, 2.6 mg/kg', 'description': 'Single intravenous infusion of nerinetide over 10 ± 1 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.181', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.782', 'ciLowerLimit': '0.545', 'ciUpperLimit': '1.121', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days or last rating', 'description': 'Number of subjects with good neurological outcome, as defined by a score of 0 to 2 on the NIHSS at Day 90 or the last rating in the sub-group of participants treated with alteplase as part of standard-of-care.\n\nThe National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating increasing severity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Mortality Rate in the Alteplase Sub-group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Drug vehicle only\n\nPlacebo: Placebo Comparator: Placebo'}, {'id': 'OG001', 'title': 'Nerinetide, 2.6 mg/kg', 'description': 'Single intravenous infusion of nerinetide over 10 ± 1 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.869', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.050', 'ciLowerLimit': '0.588', 'ciUpperLimit': '1.874', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Mortality rate, as defined by event rate (%) for mortality over the 90-day study period in the sub-group of participants treated with alteplase as part of standard-of-care', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Drug vehicle only\n\nPlacebo: Placebo Comparator: Placebo'}, {'id': 'FG001', 'title': 'Nerinetide (NA-1), 2.6 mg/kg', 'description': 'Single intravenous infusion of nerinetide over 10 ± 1 minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '556'}, {'groupId': 'FG001', 'numSubjects': '549'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '550'}, {'groupId': 'FG001', 'numSubjects': '546'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patients with acute ischaemic stroke who were selected to undergo EVT (endovascular thrombectomy) were enrolled. The trial was done at acute care hospitals. Patients were randomly assigned (1:1) to receive a single intravenous dose of nerinetide (NA-1) or placebo. All patients underwent endovascular thrombectomy and received alteplase in usual care when indicated.', 'preAssignmentDetails': 'The trial drug was administered as soon as possible after randomisation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'BG000'}, {'value': '549', 'groupId': 'BG001'}, {'value': '1105', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Drug vehicle only\n\nPlacebo: Placebo Comparator: Placebo'}, {'id': 'BG001', 'title': 'Nerinetide (NA-1), 2.6 mg/kg', 'description': 'Single intravenous infusion of nerinetide over 10 ± 1 minutes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '103'}, {'value': '71.0', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '98'}, {'value': '70.0', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '103'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '281', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '549', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '556', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '540', 'groupId': 'BG000'}, {'value': '541', 'groupId': 'BG001'}, {'value': '1081', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '453', 'groupId': 'BG000'}, {'value': '436', 'groupId': 'BG001'}, {'value': '889', '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': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Under 'Unknown or Not reported' category the number of participants for the 'Other' category is indicated", 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '505', 'groupId': 'BG002'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '414', 'groupId': 'BG002'}]}]}, {'title': 'Ireland', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Alteplase Treatment', 'classes': [{'title': 'Participants treated with alteplase', 'categories': [{'measurements': [{'value': '329', 'groupId': 'BG000'}, {'value': '330', 'groupId': 'BG001'}, {'value': '659', 'groupId': 'BG002'}]}]}, {'title': 'Participants not treated with alteplase', 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '446', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Treatment with alteplase as part of standard-of-care in addition to study drug', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-19', 'size': 1234894, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-13T15:29', 'hasProtocol': True}, {'date': '2019-05-09', 'size': 545370, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-13T15:32', 'hasProtocol': False}]}}, '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': 1105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-06', 'studyFirstSubmitDate': '2016-10-06', 'resultsFirstSubmitDate': '2020-10-22', 'studyFirstSubmitQcDate': '2016-10-07', 'lastUpdatePostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-18', 'studyFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With mRS Score of 0 to 2', 'timeFrame': '90 Days', 'description': 'Overall number of subjects experiencing a favorable functional outcome 90 days post-randomization, defined as 0 to 2 on the mRS.\n\nThe modified Rankin Scale (mRS) is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 (best outcome) to 6 (worst outcome), with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With NIHSS Score of 0 to 2', 'timeFrame': '90 Days or the last rating', 'description': 'Number of subjects with good neurological outcome, as defined by a score of 0 to 2 on the NIHSS at Day 90 or the last rating.\n\nThe National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating increasing severity.'}, {'measure': 'Mortality Rate', 'timeFrame': '90 Days', 'description': 'Mortality rate, as defined by event rate (%) for mortality over the 90-day study period'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Ischemic Stroke', 'Endovascular Thrombectomy', 'Neuroprotection', 'Tat-NR2B9c', 'NA-1', 'Nerinetide'], 'conditions': ['Stroke, Acute']}, 'referencesModule': {'references': [{'pmid': '23051991', 'type': 'BACKGROUND', 'citation': 'Hill MD, Martin RH, Mikulis D, Wong JH, Silver FL, Terbrugge KG, Milot G, Clark WM, Macdonald RL, Kelly ME, Boulton M, Fleetwood I, McDougall C, Gunnarsson T, Chow M, Lum C, Dodd R, Poublanc J, Krings T, Demchuk AM, Goyal M, Anderson R, Bishop J, Garman D, Tymianski M; ENACT trial investigators. Safety and efficacy of NA-1 in patients with iatrogenic stroke after endovascular aneurysm repair (ENACT): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2012 Nov;11(11):942-50. doi: 10.1016/S1474-4422(12)70225-9. Epub 2012 Oct 8.'}, {'pmid': '22388811', 'type': 'BACKGROUND', 'citation': 'Cook DJ, Teves L, Tymianski M. Treatment of stroke with a PSD-95 inhibitor in the gyrencephalic primate brain. Nature. 2012 Feb 29;483(7388):213-7. doi: 10.1038/nature10841.'}, {'pmid': '23035045', 'type': 'BACKGROUND', 'citation': 'Cook DJ, Teves L, Tymianski M. A translational paradigm for the preclinical evaluation of the stroke neuroprotectant Tat-NR2B9c in gyrencephalic nonhuman primates. Sci Transl Med. 2012 Oct 3;4(154):154ra133. doi: 10.1126/scitranslmed.3003824.'}, {'pmid': '18617669', 'type': 'BACKGROUND', 'citation': 'Sun HS, Doucette TA, Liu Y, Fang Y, Teves L, Aarts M, Ryan CL, Bernard PB, Lau A, Forder JP, Salter MW, Wang YT, Tasker RA, Tymianski M. Effectiveness of PSD95 inhibitors in permanent and transient focal ischemia in the rat. Stroke. 2008 Sep;39(9):2544-53. doi: 10.1161/STROKEAHA.107.506048. Epub 2008 Jul 10.'}, {'pmid': '12399596', 'type': 'BACKGROUND', 'citation': 'Aarts M, Liu Y, Liu L, Besshoh S, Arundine M, Gurd JW, Wang YT, Salter MW, Tymianski M. Treatment of ischemic brain damage by perturbing NMDA receptor- PSD-95 protein interactions. Science. 2002 Oct 25;298(5594):846-50. doi: 10.1126/science.1072873.'}, {'pmid': '10364559', 'type': 'BACKGROUND', 'citation': 'Sattler R, Xiong Z, Lu WY, Hafner M, MacDonald JF, Tymianski M. Specific coupling of NMDA receptor activation to nitric oxide neurotoxicity by PSD-95 protein. Science. 1999 Jun 11;284(5421):1845-8. doi: 10.1126/science.284.5421.1845.'}, {'pmid': '25671798', 'type': 'BACKGROUND', 'citation': 'Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015 Mar 12;372(11):1019-30. doi: 10.1056/NEJMoa1414905. Epub 2015 Feb 11.'}, {'pmid': '32087818', 'type': 'RESULT', 'citation': 'Hill MD, Goyal M, Menon BK, Nogueira RG, McTaggart RA, Demchuk AM, Poppe AY, Buck BH, Field TS, Dowlatshahi D, van Adel BA, Swartz RH, Shah RA, Sauvageau E, Zerna C, Ospel JM, Joshi M, Almekhlafi MA, Ryckborst KJ, Lowerison MW, Heard K, Garman D, Haussen D, Cutting SM, Coutts SB, Roy D, Rempel JL, Rohr AC, Iancu D, Sahlas DJ, Yu AYX, Devlin TG, Hanel RA, Puetz V, Silver FL, Campbell BCV, Chapot R, Teitelbaum J, Mandzia JL, Kleinig TJ, Turkel-Parrella D, Heck D, Kelly ME, Bharatha A, Bang OY, Jadhav A, Gupta R, Frei DF, Tarpley JW, McDougall CG, Holmin S, Rha JH, Puri AS, Camden MC, Thomalla G, Choe H, Phillips SJ, Schindler JL, Thornton J, Nagel S, Heo JH, Sohn SI, Psychogios MN, Budzik RF, Starkman S, Martin CO, Burns PA, Murphy S, Lopez GA, English J, Tymianski M; ESCAPE-NA1 Investigators. Efficacy and safety of nerinetide for the treatment of acute ischaemic stroke (ESCAPE-NA1): a multicentre, double-blind, randomised controlled trial. Lancet. 2020 Mar 14;395(10227):878-887. doi: 10.1016/S0140-6736(20)30258-0. Epub 2020 Feb 20.'}, {'pmid': '40122606', 'type': 'DERIVED', 'citation': 'Stebner A, Bosshart SL, Fujiwara S, Frei D, Tarpley J, Dowlatshahi D, Rempel JL, Hill MD, Goyal M, Ospel JM; ESCAPE-NA1 Investigators. Association of baseline infarct size, reperfusion grade and intracranial hemorrhage in patients undergoing thrombectomy. J Neurointerv Surg. 2025 Mar 23:jnis-2025-023103. doi: 10.1136/jnis-2025-023103. Online ahead of print.'}, {'pmid': '39648909', 'type': 'DERIVED', 'citation': 'Ospel JM, Goyal M, Menon BK, Almekhlafi MA, Zerna C, Nogueira RG, McTaggart RA, Demchuk AM, Poppe AY, Rempel JL, Joshi M, Kashani N, Heard K, Field TS, Dowlatshahi D, van Adel B, Swartz RH, Shah R, Sauvageau E, Puetz V, Silver FL, Campbell B, Chapot R, Tymianski M, Hill MD; ESCAPE-NA1 Investigators. Factors Influencing Nerinetide Effect on Infarct Volume in Patients Without Alteplase in the Randomized ESCAPE-NA1 Trial. Stroke. 2025 Jan;56(1):14-21. doi: 10.1161/STROKEAHA.124.048601. Epub 2024 Dec 9.'}, {'pmid': '38272571', 'type': 'DERIVED', 'citation': 'Ospel JM, Rex N, Rinkel L, Kashani N, Buck B, Rempel J, Sahlas D, Kelly ME, Budzik R, Tymianski M, Hill MD, Goyal M; ESCAPE-NA1 Investigators. Prevalence of "Ghost Infarct Core" after Endovascular Thrombectomy. AJNR Am J Neuroradiol. 2024 Mar 7;45(3):291-295. doi: 10.3174/ajnr.A8113.'}, {'pmid': '38165335', 'type': 'DERIVED', 'citation': "Fladt J, Guo J, Specht JL, Wang M, Chan LL, Mctaggart R, Buck BH, Aviv R, Swartz RH, Field TS, Tarpley J, Shah R, Goyal M, Tymianski M, Hill MD, Demchuk A, d'Esterre C, Barber P. Infarct Evolution on MR-DWI After Thrombectomy in Acute Stroke Patients Randomized to Nerinetide or Placebo: The REPERFUSE-NA1 Study. Neurology. 2024 Jan 23;102(2):e207976. doi: 10.1212/WNL.0000000000207976. Epub 2023 Dec 22."}, {'pmid': '37165867', 'type': 'DERIVED', 'citation': 'Singh N, Cimflova P, Ospel JM, Kashani N, Marko M, Mayank A, Hill MD; ESCAPE-NA1 Trial Investigators. Prevalence and Predictors of Multivessel Occlusions at Baseline Imaging in ESCAPE-NA1 Trial. Stroke. 2023 Jun;54(6):e233-e234. doi: 10.1161/STROKEAHA.123.043027. Epub 2023 May 11. No abstract available.'}, {'pmid': '37082967', 'type': 'DERIVED', 'citation': 'Singh N, Cimflova P, Ospel JM, Kashani N, Marko M, Mayank A, Nogueira RG, McTaggart RA, Demchuk AM, Poppe AY, Rempel JL, Field TS, Dowlatshahi D, van Adel B, Swartz RH, Shah R, Sauvageau E, Puetz V, Silver FL, Campbell B, Chapot R, Tymianski M, Goyal M, Almekhlafi MA, Hill MD; ESCAPE-NA1 Trial Investigators. Infarcts in a New Territory: Insights From the ESCAPE-NA1 Trial. Stroke. 2023 Jun;54(6):1477-1483. doi: 10.1161/STROKEAHA.122.042200. Epub 2023 Apr 21.'}]}, 'descriptionModule': {'briefSummary': 'The ESCAPE-NA-1 study is designed to determine the safety and efficacy of the neuroprotectant, Nerinetide (NA-1), in reducing global disability in subjects with major acute ischemic stroke (AIS) with a small established infarct core and with good collateral circulation who are selected for endovascular revascularization.', 'detailedDescription': 'Trial Objectives:\n\nThe primary objective is to determine the efficacy of the neuroprotectant, Nerinetide, in reducing global disability in subjects with major acute ischemic stroke (AIS) with a small established infarct core and with good collateral circulation selected for rapid endovascular revascularization.\n\nThe secondary objectives are to determine the efficacy of Nerinetide in:\n\n* Reducing functional dependence\n* Improving neurological outcome\n* Improving activities of daily living\n* Reducing mortality rate The leading safety objectives are to determine the effect of administering a dose of 2.6 mg/kg (up to a maximum dose of 270 mg) intravenous (IV) infusion of Nerinetide to subject with acute stroke who are selected for endovascular revascularization on serious adverse events (SAEs) and 90-day mortality.\n\nTrial Design:\n\nThis study is a Phase 3, randomized, multicentre, blinded, placebo-controlled, parallel group, single-dose design. Subjects harboring an acute ischemic stroke and who are selected for endovascular revascularization in accordance with local institutional practices and who harbor a small established infarct core and with good collateral circulation will be given a single, 2.6 mg/kg (up to a maximum dose of 270 mg) intravenous dose of Nerinetide (NA-1) or placebo as soon as they are deemed to have met the enrollment criteria and with the intention of starting administration within 30 minutes of randomization. The randomization will be by stochastic minimization to balance baseline factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Acute ischemic stroke (AIS) for immediate endovascular treatment\n2. Age 18 or greater.\n3. Onset (last-seen-well) time to randomization time within 12 hours.\n4. Disabling stroke defined as a baseline National Institutes of Health Stroke Score (NIHSS) \\> 5 at the time of randomization.\n5. Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Barthel Index (BI) \\> 90 (95 or 100). Patient must be living in their own home, apartment or seniors lodge where no nursing care is required.\n6. Confirmed symptomatic intracranial occlusion, based on multiphase or dynamic computerized tomographic angiography (CTA), at one or more of the following locations: Intracranial carotid T/L, M1 middle cerebral artery (MCA). Functionally, when defining the M1 or the M2, the bulk of the MCA territory must be ischemic.\n7. Non-contrast computed tomography (NCCT) and CTA (multiphase or dynamic) for trial eligibility performed or repeated at ESCAPE-NA1 stroke centre with endovascular suite on-site.\n8. Endovascular treatment with declared first endovascular approach as either stent retriever or aspiration device, and intended to be initiated (arterial access) within 60 minutes of baseline/qualifying NCCT and to first recanalization of 90 minutes. Study drug intended to be administered within 60 minutes of the baseline/qualifying NCCT.\n9. Signed informed consent from subject or legally authorized representative or, if required to enable inclusion by applicable national laws and regulations and the applicable independent review boards/Ethics Committee requirements for obtaining consent, from the investigator after consultation with an independent physician who is not otherwise participating in the trial.\n\nExclusion Criteria:\n\n1. Evidence of a large core of established infarction defined as ASPECTS 0-4.\n2. Evidence of absence of collateral circulation on CTA (Collateral score of 0 or 1).\n3. Intent to use any endovascular device other than a stent retriever or clot aspiration device or intra-arterial medications as the initial thrombectomy approach.\n4. Intent to use any intravenous thrombolytic other than alteplase if intravenous thrombolysis is planned.\n5. No femoral pulses, very difficult endovascular access or extreme tortuosity of great vessels that is predicted to result in an inability to deliver timely endovascular therapy. Direct common carotid or radial/brachial/axillary access is permissible.\n6. Estimated or known weight \\> 120 kg or \\< 45 kg.\n7. Pregnancy; if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (β-hCG) test is positive, or breastfeeding.\n8. Severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention, including any contraindications listed in the prescribing information approved by local authorities (e.g., patients with decompensated heart failure as a contraindication for the use of VISIPAQUE™ 270 in Germany).\n9. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic or there is suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.\n10. Prior enrolment in the ESCAPE-NA1 trial or prior receipt of NA-1 for any reason.\n11. Severe known renal impairment defined as requiring dialysis (hemo- or peritoneal) or if known a creatinine clearance \\< 29 mL/min.\n12. Patient has a severe or fatal comorbid illness that will prevent improvement or follow-up.\n13. Patient cannot complete follow-up treatment due to co-morbid non-fatal illness or they are known to be a visitor to the city or any other known reason for which follow-up would be impossible (e.g. incarcerated in a federal prison).\n14. Participation in another clinical trial investigating a drug, medical device, or a medical procedure in the 30 days preceding study inclusion.'}, 'identificationModule': {'nctId': 'NCT02930018', 'acronym': 'ESCAPE-NA1', 'briefTitle': 'Safety and Efficacy of Nerinetide (NA-1) in Subjects Undergoing Endovascular Thrombectomy for Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'NoNO Inc.'}, 'officialTitle': 'A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Intravenous NA-1 in Subjects With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy', 'orgStudyIdInfo': {'id': 'NA-1-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug vehicle only', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Nerinetide (NA-1), 2.6 mg/kg', 'interventionNames': ['Drug: Nerinetide (NA-1), 2.6 mg/kg']}], 'interventions': [{'name': 'Nerinetide (NA-1), 2.6 mg/kg', 'type': 'DRUG', 'otherNames': ['NA-1'], 'description': 'Single intravenous infusion of nerinetide over 10 ± 1 minutes', 'armGroupLabels': ['Nerinetide (NA-1), 2.6 mg/kg']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Drug vehicle only'], 'description': 'Placebo Comparator: Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Pacific Medical Center - Davies Campus', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90503', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Providence Little Company of Mary Medical Center Torrance', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80110', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Health Medical Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'WellStar Health Systems', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital of Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '11220', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Lutheran Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health Forsyth Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Riverside Radiology', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19001', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Memorial Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Presbyterian', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Chattanooga Center for Neurologic Research', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '78550', 'city': 'Harlingen', 'state': 'Texas', 'country': 'United States', 'facility': 'Valley Baptist Medical Center', 'geoPoint': {'lat': 26.19063, 'lon': -97.6961}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center- Cherry Hill Campus', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Adelaide', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Parkville', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': 'T2N2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary - Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver Stroke Program Research Office/ Vancouver General Hosptial', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Science Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre- University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network - Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM Hopital Notre-Dame', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3A1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Neurological Institute and Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1J 1Z4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': "CHU de Quebec- Universite Laval- Hopital de l'Enfant-Jesus", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Royal University Hospital', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus Dresdner Neurovaskulares Centrum', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': 'D - 45131', 'city': 'Essen', 'country': 'Germany', 'facility': 'Klinik für Radiologie und Neuroradiologie', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'University Medical Center Goettingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Neurologische Klinik, Universität Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Mater Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Dongsan Medical Centre', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei Univ, Severence', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinksa Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'Michael D Hill, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NoNO Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Calgary', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}