Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-02 @ 2:12 PM
Study NCT ID:
NCT04241068
Status:
TERMINATED
Last Update Posted:
2025-02-21
First Post:
2020-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600266', 'term': 'aducanumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogen.com', 'phone': '866-633-4636', 'title': 'US Biogen Clinical Trial Center', 'organization': 'Biogen'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "The study was terminated prematurely based on the sponsor's decision."}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to last follow-up visit (up to Week 170)', 'description': 'The safety population included all participants who had received at least one dose of aducanumab in this study (221AD304).', 'eventGroups': [{'id': 'EG000', 'title': 'Aducanumab', 'description': 'Participants were administered aducanumab 10 mg/kg by IV infusions, Q4W for 100 weeks during the Core Treatment Period. Eligible participants continued to receive aducanumab 10 mg/kg IV infusion, Q4W, for 52 weeks during the LTE Treatment Period.', 'otherNumAtRisk': 1696, 'deathsNumAtRisk': 1696, 'otherNumAffected': 1351, 'seriousNumAtRisk': 1696, 'deathsNumAffected': 37, 'seriousNumAffected': 416}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 87}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 130}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 98}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 427}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 107}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 122}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 92}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 355}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 91}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 158}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 140}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 443}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Amyloid related imaging abnormality-oedema/effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 424}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 146}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 246}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Superficial siderosis of central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 232}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 104}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 103}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 130}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Anaemia vitamin b12 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ventricle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anorectal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Duodenal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Leukoplakia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oesophageal motility disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 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'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chondrocalcinosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Osteoporotic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atypical fibroxanthoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Benign nipple neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Endometrial cancer stage i', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Follicular lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastric cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Glioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Glioblastoma multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Intraductal papillary mucinous neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Invasive lobular breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Invasive papillary breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lung adenocarcinoma stage iii', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lung squamous cell carcinoma stage iii', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Malignant peritoneal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Metastatic bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Metastatic uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Squamous cell carcinoma of the tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': "Waldenstrom's macroglobulinaemia", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Amyloid related imaging abnormality-oedema/effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Autonomic nervous system imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': "Bell's palsy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebellar haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebellar stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': "Dementia alzheimer's type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': "Dementia of the alzheimer's type, with delirium", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dementia with lewy bodies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haemorrhagic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Idiopathic generalised epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ischaemic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Mental impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Small fibre neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Transient global amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Behaviour disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Neuropsychological symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Psychiatric decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Somatic symptom disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Breast haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Breast swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Colpocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Female genital tract fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Choking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Obstructive sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Leukoplakia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Loss of personal independence in daily activities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Internal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1696, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Core Treatment Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1696', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aducanumab', 'description': 'Participants were administered aducanumab 10 mg/kg by IV infusions, Q4W for 100 weeks during the Core Treatment Period.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '1549', 'groupId': 'OG000'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study drug to end of follow-up (up to Week 118)', 'description': 'An AE is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal(investigational) product, whether or not related to medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in significant disability/incapacity or congenital anomaly, is medically important event. TEAE or Serious TEAEs are defined as any AE that has an onset date and time that is on or after date and time of first dose of study treatment, or that has worsened after date and time of first dose of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population for the core period included all participants who had received at least one dose of aducanumab in the core period.'}, {'type': 'PRIMARY', 'title': 'Core Treatment Period: Number of Participants With AEs Leading to Treatment Discontinuation (TD) and Study Withdrawal (SW)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1696', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aducanumab', 'description': 'Participants were administered aducanumab 10 mg/kg by IV infusions, Q4W for 100 weeks during the Core Treatment Period.'}], 'classes': [{'title': 'AEs leading to TD', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}]}]}, {'title': 'AEs leading to SW', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study drug to end of follow-up (up to Week 118)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population for the core period included all participants who had received at least one dose of aducanumab in the core period.'}, {'type': 'PRIMARY', 'title': 'Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality-Edema (ARIA-E)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1656', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aducanumab', 'description': 'Participants were administered aducanumab 10 mg/kg by IV infusions, Q4W for 100 weeks during the Core Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '422', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 118', 'description': 'Number of participants diagnosed with ARIA edema are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The safety magnetic resonance imaging (MRI) population for the core period included all participants who had received at least one dose of aducanumab in the core period and had at least one post-baseline MRI assessment in the core period. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis."}, {'type': 'PRIMARY', 'title': 'Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1656', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aducanumab', 'description': 'Participants were administered aducanumab 10 mg/kg by IV infusions, Q4W for 100 weeks during the Core Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '505', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 118', 'description': 'Number of participants diagnosed with ARIA hemmorrhage or superficial siderosis are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The safety MRI population for the core period included all participants who had received at least one dose of aducanumab in the core period and had at least one post-baseline MRI assessment in the core period. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis."}, {'type': 'PRIMARY', 'title': 'Core Treatment Period: Number of Participants With Positive Antidrug Antibodies (ADAs) in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1595', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aducanumab', 'description': 'Participants were administered aducanumab 10 mg/kg by IV infusions, Q4W for 100 weeks during the Core Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 102', 'description': 'The presence of serum ADAs was determined using a validated assay. A standard 3-tiered approach was used including screening assay, confirmatory assay, and titration assay. The number of participants with a positive response to ADAs are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The immunogenicity population for the core period included all participants who had received at least one dose of aducanumab in the core period and had at least one post-dose sample evaluated for immunogenicity in the core period. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aducanumab', 'description': 'Participants were administered aducanumab 10 milligrams per kilogram (mg/kg) by intravenous (IV) infusions every four weeks (Q4W) for 100 weeks during the Core Treatment Period. Eligible participants continued to receive aducanumab 10 mg/kg IV infusion, Q4W, for 52 weeks during the LTE Treatment Period.'}], 'periods': [{'title': 'Core Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1696'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '578'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '91'}]}, {'type': 'Change of Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '143'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '67'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'Loss of Capacity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Study Visit Burden', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'Withdrawal by Guardian/caretaker', 'reasons': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}]}]}, {'title': 'LTE Period', 'milestones': [{'type': 'STARTED', 'comment': '77 participants were not eligible for LTE period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1041'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '508'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '533'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Change of Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '71'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Loss of Capacity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Site Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '276'}]}, {'type': 'Study Visit Burden', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Guardian/caretaker', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '65'}]}]}], 'recruitmentDetails': 'Participants took part in the study at the investigative sites in the United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Japan, South Korea, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, and United Kingdom from 02 Mar 2020 to 22 Jul 2024.', 'preAssignmentDetails': 'A total of 1696 participants were enrolled and treated in the core period, of which 1118 participants completed the core period. Out of the participants who completed the core period, 1041 participants entered the long-term extension (LTE) period, and 508 participants completed the LTE period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1696', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aducanumab', 'description': 'Participants were administered aducanumab 10 mg/kg by IV infusions, Q4W for 100 weeks during the Core Treatment Period. Eligible participants continued to receive aducanumab 10 mg/kg IV infusion, Q4W, for 52 weeks during the LTE Treatment Period.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.1', 'spread': '7.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '881', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '815', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Asian', 'measurements': [{'value': '185', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1399', 'groupId': 'BG000'}]}, {'title': 'Not Reported Due to Confidentiality Regulations', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1562', 'groupId': 'BG000'}]}, {'title': 'Not Reported Due to Confidentiality Regulations', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified Intent-to-treat (mITT) population included all participants who had received at least one dose of aducanumab in the study 221AD304.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-19', 'size': 3206733, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-31T09:21', 'hasProtocol': True}, {'date': '2024-05-10', 'size': 2789759, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-31T09:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1696}}, 'statusModule': {'whyStopped': "Sponsor's Decision", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2020-01-22', 'resultsFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2020-01-22', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-31', 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core Treatment Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs', 'timeFrame': 'From the first dose of study drug to end of follow-up (up to Week 118)', 'description': 'An AE is any untoward medical occurrence in a participant/clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal(investigational) product, whether or not related to medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in significant disability/incapacity or congenital anomaly, is medically important event. TEAE or Serious TEAEs are defined as any AE that has an onset date and time that is on or after date and time of first dose of study treatment, or that has worsened after date and time of first dose of study treatment.'}, {'measure': 'Core Treatment Period: Number of Participants With AEs Leading to Treatment Discontinuation (TD) and Study Withdrawal (SW)', 'timeFrame': 'From the first dose of study drug to end of follow-up (up to Week 118)', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.'}, {'measure': 'Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality-Edema (ARIA-E)', 'timeFrame': 'Up to Week 118', 'description': 'Number of participants diagnosed with ARIA edema are reported.'}, {'measure': 'Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H)', 'timeFrame': 'Up to Week 118', 'description': 'Number of participants diagnosed with ARIA hemmorrhage or superficial siderosis are reported.'}, {'measure': 'Core Treatment Period: Number of Participants With Positive Antidrug Antibodies (ADAs) in Serum', 'timeFrame': 'Up to Week 102', 'description': 'The presence of serum ADAs was determined using a validated assay. A standard 3-tiered approach was used including screening assay, confirmatory assay, and titration assay. The number of participants with a positive response to ADAs are reported.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\nCore Treatment Period:\n\n* Participant was participating in an aducanumab clinical study at the time of the announcement of early termination (feeder studies).\n* Has one care partner who, in the Investigator's opinion, has adequate contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities.\n\nLTE Treatment Period:\n\n* Participant must have completed the Core study period (Week 102) and adequately tolerated 10 mg/kg of aducanumab during the Core study period in the opinion of the Investigator.\n* Has one informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities.\n\nKey Exclusion Criteria:\n\nCore Treatment Period:\n\n* Any medical or neurological condition (other than Alzheimer's Disease) that might be a contributing cause of the participant's cognitive impairment.\n* Stroke or any unexplained loss of consciousness within 1 year prior to Screening.\n* Clinically significant unstable psychiatric illness in past 6 months.\n* History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening.\n* A seizure event that occurred after the last visit of the feeder study and before Screening for this study.\n* Evidence of impaired liver function as shown by an abnormal liver function profile at Screening.\n* History of or known seropositivity for HIV.\n* Clinically significant systemic illness or serious infection within 30 days prior to or during Screening.\n* Contraindications to having a brain magnetic resonance imaging (MRI).\n\nLTE Treatment Period:\n\n* Any medical or psychiatric contraindication or clinically significant abnormality that, in the opinion of the Investigator, will substantially increase the risk associated with the participant's enrollment in and completion of the study.\n\nNote- Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT04241068', 'briefTitle': "A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205", 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': "Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205", 'orgStudyIdInfo': {'id': '221AD304'}, 'secondaryIdInfos': [{'id': '2019-004368-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aducanumab', 'description': 'Participants will be administered aducanumab 10 milligrams per kilogram (mg/kg) by intravenous (IV) infusions every four weeks (Q4W) for a duration of 100 weeks during the Core Treatment Period. Eligible participants will continue to receive aducanumab 10 mg/kg IV infusion, Q4W, for 52 weeks during the Long-Term Extension (LTE) Treatment Period.', 'interventionNames': ['Drug: Aducanumab']}], 'interventions': [{'name': 'Aducanumab', 'type': 'DRUG', 'otherNames': ['BIIB037'], 'description': 'Administered as specified in the treatment arm.', 'armGroupLabels': ['Aducanumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Banner Alzheimer's Institute", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Dignity Health', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Sun Health Research Institute', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '85718', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Center for Neurosciences', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Neurology Center of North Orange County', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92607', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UCI MIND', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Senior Clinical Trials, Inc.', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC Keck School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Mary S. 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