Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-30 @ 12:36 AM
Study NCT ID:
NCT01339559
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2011-04-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C482793', 'term': 'brivaracetam'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'UCBCares@ucb.com', 'phone': '+1844 599', 'title': 'UCB', 'phoneExt': '2273', 'organization': 'Cares'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Entry Visit (Month 0) until the Last Visit (up to 84 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Brivaracetam (SS)', 'description': 'Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).', 'otherNumAtRisk': 766, 'deathsNumAtRisk': 766, 'otherNumAffected': 421, 'seriousNumAtRisk': 766, 'deathsNumAffected': 5, 'seriousNumAffected': 140}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 67, 'numAffected': 59}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 102, 'numAffected': 65}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 101, 'numAffected': 59}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 86, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 47, 'numAffected': 40}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 71, 'numAffected': 44}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 60, 'numAffected': 43}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 59, 'numAffected': 46}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 56, 'numAffected': 41}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 187, 'numAffected': 102}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 123, 'numAffected': 100}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 88, 'numAffected': 73}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 53, 'numAffected': 45}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 48, 'numAffected': 42}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}], 'seriousEvents': [{'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Hypoplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Sickle cell anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Oesophageal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Gastroenteritis escherichia coli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Infected cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Otitis media chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Perineal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Pharyngitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Typhoid fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Brain contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Eye injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Nail injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Pubis fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Skeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Spinal cord injury cervical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Diagnostic procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Gliomatosis cerebri', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Thymoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Seizure cluster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Partial seizures with secondary generalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Cerebellar syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Cervical cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Complex partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': "Dementia Alzheimer's type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Simple partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Imminent abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Delirium febrile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Emotional disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Menometrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Spermatic cord haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Intervertebral disc operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Tenodesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 766, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '766', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brivaracetam (SS)', 'description': 'Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).'}], 'classes': [{'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Entry Visit (Month 0) until the Last Visit (up to 84 months)', 'description': 'Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Withdrew Due to Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '766', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brivaracetam (SS)', 'description': 'Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Entry Visit (Month 0) until the Last Visit (up to 84 months)', 'description': 'An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '766', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brivaracetam (SS)', 'description': 'Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Entry Visit (Month 0) until the Last Visit (up to 84 months)', 'description': 'A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:\n\n* Results in death\n* Is life-threatening\n* Requires in patient hospitalization or prolongation of existing hospitalization\n* Is a congenital anomaly or birth defect\n* Is as infection that requires treatment parenteral antibiotics\n* Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brivaracetam (POS Efficacy)', 'description': 'Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Partial Onset Seizure Efficacy Set (POS Efficacy).'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '23.7'}]}]}, {'title': 'On Treatment', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '12.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline of the previous study until the Last Visit (up to 84 months)', 'description': 'The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.', 'unitOfMeasure': 'Seizures per 28 days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brivaracetam (POS Efficacy)', 'description': 'Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Partial Onset Seizure Efficacy Set (POS Efficacy).'}], 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'groupId': 'OG000', 'lowerLimit': '16.8', 'upperLimit': '81.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline of the previous study until the Last Visit (up to 84 months)', 'description': 'The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as:\n\n(the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines.\n\nNote: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of percent change in POS frequency.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.\n\nParticipants from N01258 were excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Responder Rate in POS (Type I) Frequency Over the Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brivaracetam (POS Efficacy)', 'description': 'Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Partial Onset Seizure Efficacy Set (POS Efficacy).'}], 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of the previous study until the Last Visit (up to 84 months)', 'description': 'A responder is defined as a subject with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study.\n\nNote: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of responder rates in POS frequency.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all subjects with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.\n\nParticipants from N01258 were excluded from this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brivaracetam', 'description': 'Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '766'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '368'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '398'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '92'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '164'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Subject choice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '89'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Study closure at site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Incarcerated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Epilepsy surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Pregnancy planned', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Left the country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': "Patient didn't wish to continue", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'PI decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study started to enroll patients in May 2011 and concluded in April 2019. 767 participants were included in the Enrolled Set but 1 participant from the United States of America was lost to follow-up and was excluded from the Safety Analysis Set.', 'preAssignmentDetails': 'Participants Flow refers to the Safety Set (SS).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '766', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Brivaracetam', 'description': 'Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down-Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '722', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'spread': '12.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '396', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '370', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '561', 'groupId': 'BG000'}]}, {'title': 'African-American', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '77', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics refer to the Safety Set which consisted of all participants who took at least 1 dose of study medication.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-15', 'size': 5167645, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-07T10:07', 'hasProtocol': True}, {'date': '2019-01-28', 'size': 2241592, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-07T10:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 767}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03532516', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-16', 'studyFirstSubmitDate': '2011-04-19', 'resultsFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2011-04-19', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-25', 'studyFirstPostDateStruct': {'date': '2011-04-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)', 'timeFrame': 'From Entry Visit (Month 0) until the Last Visit (up to 84 months)', 'description': 'Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.'}, {'measure': 'Percentage of Participants Who Withdrew Due to Adverse Events (AEs)', 'timeFrame': 'From Entry Visit (Month 0) until the Last Visit (up to 84 months)', 'description': 'An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.'}, {'measure': 'Percentage of Participants With at Least One Serious Adverse Event (SAE)', 'timeFrame': 'From Entry Visit (Month 0) until the Last Visit (up to 84 months)', 'description': 'A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:\n\n* Results in death\n* Is life-threatening\n* Requires in patient hospitalization or prolongation of existing hospitalization\n* Is a congenital anomaly or birth defect\n* Is as infection that requires treatment parenteral antibiotics\n* Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.'}], 'secondaryOutcomes': [{'measure': 'Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period', 'timeFrame': 'From Baseline of the previous study until the Last Visit (up to 84 months)', 'description': 'The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.'}, {'measure': 'Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period', 'timeFrame': 'From Baseline of the previous study until the Last Visit (up to 84 months)', 'description': 'The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as:\n\n(the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines.\n\nNote: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of percent change in POS frequency.'}, {'measure': 'Responder Rate in POS (Type I) Frequency Over the Evaluation Period', 'timeFrame': 'From Baseline of the previous study until the Last Visit (up to 84 months)', 'description': 'A responder is defined as a subject with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study.\n\nNote: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of responder rates in POS frequency.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Brivaracetam', 'Partial Onset Seizures', 'Adjunctive treatment'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '34218211', 'type': 'RESULT', 'citation': 'Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.'}, {'pmid': '36435010', 'type': 'DERIVED', 'citation': 'Brandt C, Dimova S, Elmoufti S, Laloyaux C, Nondonfaz X, Klein P. Retention, efficacy, tolerability, and quality of life during long-term adjunctive brivaracetam treatment by number of lifetime antiseizure medications: A post hoc analysis of phase 3 trials in adults with focal seizures. Epilepsy Behav. 2023 Jan;138:108967. doi: 10.1016/j.yebeh.2022.108967. Epub 2022 Nov 23.'}, {'pmid': '26899665', 'type': 'DERIVED', 'citation': 'Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.'}, {'pmid': '26471380', 'type': 'DERIVED', 'citation': 'Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212. Epub 2015 Oct 16.'}], 'seeAlsoLinks': [{'url': 'http://www.briviact.com/briviact-PI.pdf?v=1479491757', 'label': 'Product Information'}, {'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).', 'detailedDescription': 'The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject completed the Treatment Period of N01358 or the evaluation period of N01258\n* Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted\n* Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected\n* Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible\n\nExclusion Criteria:\n\n* Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies\n* Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject\n* Poor compliance with the visit schedule or medication intake in the previous BRV study\n* Planned participation in any other clinical study of another investigational drug or device during this study\n* Pregnant or lactating woman\n* Any medical condition which, in the Investigator's opinion, warrants exclusion\n* Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months"}, 'identificationModule': {'nctId': 'NCT01339559', 'acronym': 'BRITE™', 'briefTitle': 'Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy', 'orgStudyIdInfo': {'id': 'N01379'}, 'secondaryIdInfos': [{'id': '2010-020345-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brivaracetam', 'description': 'Brivaracetam with a maximum of 200 mg/day', 'interventionNames': ['Drug: Brivaracetam']}], 'interventions': [{'name': 'Brivaracetam', 'type': 'DRUG', 'otherNames': ['UCB34714'], 'description': 'Tablet, Flexible dosing up to 200 mg/day, twice daily.\n\nThe study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.', 'armGroupLabels': ['Brivaracetam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': '001', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': '013', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85718', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': '006', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': '775', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': '025', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': '060', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': '071', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32819', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': '027', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': '064', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': '023', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30165', 'city': 'Rome', 'state': 'Georgia', 'country': 'United States', 'facility': '048', 'geoPoint': {'lat': 34.25704, 'lon': -85.16467}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': '039', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': '029', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': '005', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '60190', 'city': 'Winfield', 'state': 'Illinois', 'country': 'United States', 'facility': '017', 'geoPoint': {'lat': 41.8617, 'lon': -88.1609}}, {'zip': '50010', 'city': 'Ames', 'state': 'Iowa', 'country': 'United States', 'facility': '020', 'geoPoint': {'lat': 42.03471, 'lon': -93.61994}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': '069', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': '780', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': '008', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '20603', 'city': 'Waldorf', 'state': 'Maryland', 'country': 'United States', 'facility': '068', 'geoPoint': {'lat': 38.62456, 'lon': -76.93914}}, {'zip': '55422', 'city': 'Golden Valley', 'state': 'Minnesota', 'country': 'United States', 'facility': '009', 'geoPoint': {'lat': 45.00969, 'lon': -93.34912}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': '032', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '08619', 'city': 'Hamilton', 'state': 'New Jersey', 'country': 'United States', 'facility': '042', 'geoPoint': {'lat': 40.20706, 'lon': -74.08125}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': '099', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': '022', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': '098', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '28806', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': '010', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': '003', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': '034', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': '778', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': '070', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': '002', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': '043', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': '091', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74136-83', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': '054', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': '015', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': '028', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29965', 'city': 'Port Royal', 'state': 'South Carolina', 'country': 'United States', 'facility': '021', 'geoPoint': {'lat': 32.37896, 'lon': -80.69265}}, {'zip': '37232-25', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': '776', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': '061', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75251', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': '011', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75251', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': '777', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': '035', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': '049', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76063', 'city': 'Mansfield', 'state': 'Texas', 'country': 'United States', 'facility': '050', 'geoPoint': {'lat': 32.56319, 'lon': -97.14168}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': '036', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': '056', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': '052', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': '057', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': '202', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Linz', 'country': 'Austria', 'facility': '201', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Vienna', 'country': 'Austria', 'facility': '203', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Hechtel-Eksel', 'country': 'Belgium', 'facility': '226', 'geoPoint': {'lat': 51.14166, 'lon': 5.37609}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': '227', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Belo Horizonte', 'country': 'Brazil', 'facility': '104', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'city': 'Florianópolis', 'country': 'Brazil', 'facility': '100', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': '101', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Blagoevgrad', 'country': 'Bulgaria', 'facility': '294', 'geoPoint': {'lat': 42.01457, 'lon': 23.09804}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': '286', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': '287', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': '075', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': '078', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': '076', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': '077', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': '080', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'city': 'Montreal', 'country': 'Canada', 'facility': '079', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Brno', 'country': 'Czechia', 'facility': '917', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Kroměříž', 'country': 'Czechia', 'facility': '916', 'geoPoint': {'lat': 49.29785, 'lon': 17.39312}}, {'city': 'Ostrava', 'country': 'Czechia', 'facility': '251', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'city': 'Ostrava', 'country': 'Czechia', 'facility': '256', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'city': 'Ostrava Poruba', 'country': 'Czechia', 'facility': '913'}, {'city': 'Prague', 'country': 'Czechia', 'facility': '252', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': '253', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Zlín', 'country': 'Czechia', 'facility': '250', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': '650', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': '652', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tartu', 'country': 'Estonia', 'facility': '651', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Kuopio', 'country': 'Finland', 'facility': '275', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Tampere', 'country': 'Finland', 'facility': '276', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Béthune', 'country': 'France', 'facility': '301', 'geoPoint': {'lat': 50.52965, 'lon': 2.64003}}, {'city': 'Montpellier', 'country': 'France', 'facility': '305', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Berlin', 'country': 'Germany', 'facility': '329', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bernau', 'country': 'Germany', 'facility': '326', 'geoPoint': {'lat': 47.80018, 'lon': 8.0383}}, {'city': 'Bielefeld', 'country': 'Germany', 'facility': '332', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': '902', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': '331', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Kiel', 'country': 'Germany', 'facility': '327', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Marburg', 'country': 'Germany', 'facility': '900', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'city': 'München', 'country': 'Germany', 'facility': '335', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Osnabrück', 'country': 'Germany', 'facility': '334', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'city': 'Ravensburg', 'country': 'Germany', 'facility': '330', 'geoPoint': {'lat': 47.78198, 'lon': 9.61062}}, {'city': 'Ulm', 'country': 'Germany', 'facility': '328', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': '700', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': '701', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': '410', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': '411', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': '412', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Hajdú-Bihar', 'country': 'Hungary', 'facility': '414'}, {'city': 'Szekszárd', 'country': 'Hungary', 'facility': '413', 'geoPoint': {'lat': 46.34723, 'lon': 18.71189}}, {'city': 'Nashik', 'state': 'Maharashtra', 'country': 'India', 'facility': '731', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'city': 'Bangalore', 'country': 'India', 'facility': '726', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Hyderabad', 'country': 'India', 'facility': '727', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Madurai', 'country': 'India', 'facility': '729', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}, {'city': 'Mumbai', 'country': 'India', 'facility': '725', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Mumbai', 'country': 'India', 'facility': '728', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Bari', 'country': 'Italy', 'facility': '378', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Florence', 'country': 'Italy', 'facility': '380', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Milan', 'country': 'Italy', 'facility': '379', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Monserrato', 'country': 'Italy', 'facility': '377', 'geoPoint': {'lat': 39.25642, 'lon': 9.1444}}, {'city': 'Napoli', 'country': 'Italy', 'facility': '386', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Perugia', 'country': 'Italy', 'facility': '376', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Pisa', 'country': 'Italy', 'facility': '375', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Pozzilli', 'country': 'Italy', 'facility': '383', 'geoPoint': {'lat': 41.51142, 'lon': 14.06252}}, {'city': 'Reggio Calabria', 'country': 'Italy', 'facility': '384', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'city': 'Itami', 'state': 'Hyōgo', 'country': 'Japan', 'facility': '852', 'geoPoint': {'lat': 34.78427, 'lon': 135.40126}}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': '855', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Osaka', 'country': 'Japan', 'facility': '850', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': '851', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Yokohama', 'country': 'Japan', 'facility': '854', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Daugavpils', 'country': 'Latvia', 'facility': '627', 'geoPoint': {'lat': 55.88333, 'lon': 26.53333}}, {'city': 'Jēkabpils', 'country': 'Latvia', 'facility': '629', 'geoPoint': {'lat': 56.49903, 'lon': 25.85735}}, {'city': 'Riga', 'country': 'Latvia', 'facility': '628', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Valmiera', 'country': 'Latvia', 'facility': '625', 'geoPoint': {'lat': 57.54108, 'lon': 25.42751}}, {'city': 'Alytus', 'country': 'Lithuania', 'facility': '425', 'geoPoint': {'lat': 54.39574, 'lon': 24.03885}}, {'city': 'Kaunas', 'country': 'Lithuania', 'facility': '427', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': '426', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': '126', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': '128', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'city': 'Aguascalientes', 'country': 'Mexico', 'facility': '129', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'city': 'Culiacán', 'country': 'Mexico', 'facility': '127', 'geoPoint': {'lat': 24.80209, 'lon': -107.39421}}, {'city': 'Distrito Federal', 'country': 'Mexico', 'facility': '125', 'geoPoint': {'lat': 16.59, 'lon': -93.02694}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': '130', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Heemstede', 'country': 'Netherlands', 'facility': '401', 'geoPoint': {'lat': 52.34992, 'lon': 4.62301}}, {'city': 'Heeze', 'country': 'Netherlands', 'facility': '400', 'geoPoint': {'lat': 51.3828, 'lon': 5.57145}}, {'city': 'Zwolle', 'country': 'Netherlands', 'facility': '403', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'city': 'Bialystok', 'country': 'Poland', 'facility': '475', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': '485', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': '791', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Katowice', 'country': 'Poland', 'facility': '478', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Katowice', 'country': 'Poland', 'facility': '480', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Katowice', 'country': 'Poland', 'facility': '481', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Katowice', 'country': 'Poland', 'facility': '795', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Krakow', 'country': 'Poland', 'facility': '476', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Krakow', 'country': 'Poland', 'facility': '793', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lublin', 'country': 'Poland', 'facility': '483', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Poznan', 'country': 'Poland', 'facility': '477', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Poznan', 'country': 'Poland', 'facility': '479', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Poznan', 'country': 'Poland', 'facility': '482', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': '488', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': '794', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'facility': '038', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'city': "Kazan'", 'country': 'Russia', 'facility': '501', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': "Kazan'", 'country': 'Russia', 'facility': '506', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Moscow', 'country': 'Russia', 'facility': '502', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': '503', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': '509', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'city': 'Smolensk', 'country': 'Russia', 'facility': '508', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'city': 'Busan', 'country': 'South Korea', 'facility': '753', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '750', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '751', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': '754', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': '528', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': '529', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': '535', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': '540', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Donostia / San Sebastian', 'country': 'Spain', 'facility': '539', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': '532', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Valencia', 'country': 'Spain', 'facility': '527', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': '537', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valladolid', 'country': 'Spain', 'facility': '526', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': '551', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Linköping', 'country': 'Sweden', 'facility': '552', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': '550', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': '806', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': '801', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': '800', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': '803', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'city': 'Morriston', 'state': 'Swansea', 'country': 'United Kingdom', 'facility': '602', 'geoPoint': {'lat': 51.66995, 'lon': -3.92941}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': '603', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'London', 'country': 'United Kingdom', 'facility': '600', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': '605', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': '607', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'city': 'Salford', 'country': 'United Kingdom', 'facility': '608', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'city': 'Truro', 'country': 'United Kingdom', 'facility': '601', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}], 'overallOfficials': [{'name': 'UCB Cares', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 844 599 2273 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB BIOSCIENCES, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}