Viewing Study NCT00552305

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 3:22 AM
Ignite Modification Date: 2026-03-13 @ 2:53 AM
Study NCT ID: NCT00552305
Status: COMPLETED
Last Update Posted: 2018-07-17
First Post: 2007-10-30
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078334', 'term': 'Lacosamide'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 887 822 9493', 'title': 'UCB (Study Director)', 'organization': 'UCB Clinical Trial Call Center'}, 'certainAgreement': {'otherDetails': 'UCB has \\> 60 but \\<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients', 'eventGroups': [{'id': 'EG000', 'title': 'Lacosamide', 'description': '50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)', 'otherNumAtRisk': 370, 'otherNumAffected': 307, 'seriousNumAtRisk': 370, 'seriousNumAffected': 125}], 'otherEvents': [{'term': 'DIPLOPIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 92, 'numAffected': 63}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'VISION BLURRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 60, 'numAffected': 47}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 89, 'numAffected': 64}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 71, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 40, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 77, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 108, 'numAffected': 61}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 111, 'numAffected': 60}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 62, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 42, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 48, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 34, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 129, 'numAffected': 57}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SKIN LACERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 117, 'numAffected': 50}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'EXCORIATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 50, 'numAffected': 27}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'JOINT SPRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 23, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 63, 'numAffected': 43}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 49, 'numAffected': 33}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 42, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 30, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 254, 'numAffected': 147}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 145, 'numAffected': 77}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'COORDINATION ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 69, 'numAffected': 53}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 50, 'numAffected': 41}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'TREMOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 55, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MEMORY IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 29, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 32, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'BALANCE DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 34, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'NYSTAGMUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 26, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 35, 'numAffected': 33}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 36, 'numAffected': 33}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 33, 'numAffected': 29}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PHARYNGOLARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 34, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 33, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'seriousEvents': [{'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SINUS BRADYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ATRIOVENTRICULAR BLOCK FIRST DEGREE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ACUTE CORONARY SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'BRADYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CARDIAC FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CARDIOMYOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CORONARY ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'VISION BLURRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'COLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HAEMORRHOIDS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'IRRITABLE BOWEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'RECTAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'COLONIC POLYP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ILEUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ENTEROCELE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'NON-CARDIAC CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'IRRITABILITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CHOLELITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'BACTERIAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'GASTROINTESTINAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HAND FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DRUG TOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HEAD INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'INTENTIONAL OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CEREBRAL HAEMORRHAGE TRAUMATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PELVIC FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'POST-TRAUMATIC PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'TREATMENT NONCOMPLIANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'UPPER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CERVICAL VERTEBRAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'LOWER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PNEUMOTHORAX TRAUMATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'RIB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ROAD TRAFFIC ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'THORACIC VERTEBRAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'TIBIA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HIP FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MEDICAL DEVICE COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SPINAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'THERMAL BURN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'JOINT INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'THERAPEUTIC AGENT TOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ELECTROENCEPHALOGRAM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ELECTROCARDIOGRAM QRS COMPLEX PROLONGED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'BIOPSY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'INVESTIGATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ELECTROCARDIOGRAM ST SEGMENT ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SINGLE PHOTON EMISSION COMPUTERISED TOMOGRAM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'BLOOD CREATINE PHOSPHOKINASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ELECTROCARDIOGRAM CHANGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HEART RATE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'URINARY CASTS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HYPOCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HYPERCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'FLANK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SPINAL COLUMN STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'LUMBAR SPINAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CHRONIC LYMPHOCYTIC LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HEPATIC NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HAEMANGIOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'GLIOBLASTOMA MULTIFORME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'THYROID NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'OVARIAN CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'COLON NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 26, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'STATUS EPILEPTICUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HEMIPARESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'GRAND MAL CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'EPILEPSY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PARTIAL SEIZURES WITH SECONDARY GENERALISATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CEREBRAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'METABOLIC ENCEPHALOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MYASTHENIA GRAVIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MYASTHENIA GRAVIS CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'COGNITIVE DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'COORDINATION ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'BALANCE DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PSYCHOMOTOR HYPERACTIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'OPTIC NEURITIS RETROBULBAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'COMPLEX PARTIAL SEIZURES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PREGNANCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CONFUSIONAL STATE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'MAJOR DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'AGGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SUICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'EPILEPTIC PSYCHOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HALLUCINATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PARANOIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SUICIDE ATTEMPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ACUTE PSYCHOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HALLUCINATION, AUDITORY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'NIGHTMARE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'NEPHROLITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HAEMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PROTEINURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DYSFUNCTIONAL UTERINE BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'UTERINE HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PULMONARY FIBROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ASPHYXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'PNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'ABORTION INDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'THERAPY REGIMEN CHANGED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'BRAIN OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'HYSTERECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'SURGERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'BRAIN LOBECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'STENT PLACEMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'VAGAL NERVE STIMULATOR REMOVAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'NASAL SEPTAL OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'CIRCULATORY COLLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)'}], 'classes': [{'categories': [{'measurements': [{'value': '343', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the Treatment Period (up to 8 years)', 'description': 'Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the Treatment Period (up to 8 years)', 'description': 'Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)'}], 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the Treatment Period (up to 8 years)', 'description': 'A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.'}, {'type': 'SECONDARY', 'title': 'Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.8', 'groupId': 'OG000', 'lowerLimit': '-100.0', 'upperLimit': '408.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, End of Treatment Period (up to 8 years)', 'description': 'Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.\n\nNegative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.'}, {'type': 'SECONDARY', 'title': 'Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)'}], 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment Period (up to 8 years)', 'description': 'At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lacosamide', 'description': '50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '370'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'Lack of efficacy/withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of efficacy (LoE)/adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Adverse event (AE)/withdrew (WD) consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Unsatisfactory compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Poor compliance/lost to follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'AE/Other: prohibited drug required', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'LoE/WD consent/Other: cannot make visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other: Site closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Other: Personal problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other: Unable to attend visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other: Subject underwent surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Other: Subject became pregnant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other: Health problems, not drug related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other: Subject moved from area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Other: Subject incarcerated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other: Subject went to rehab', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was started in August of 2001 with recruitment occurring in the United States, Germany, Hungary, Lithuania, Poland, Sweden, Switzerland, and the United Kingdom. The study had last patient last visit in February of 2010.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lacosamide', 'description': '50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '364', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.8', 'spread': '11.01', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '192', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '178', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '248', 'groupId': 'BG000'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'nctId': 'NCT03559673', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-20', 'studyFirstSubmitDate': '2007-10-30', 'resultsFirstSubmitDate': '2011-02-23', 'studyFirstSubmitQcDate': '2007-10-31', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-08-02', 'studyFirstPostDateStruct': {'date': '2007-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)', 'timeFrame': 'During the Treatment Period (up to 8 years)', 'description': 'Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.'}, {'measure': 'Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)', 'timeFrame': 'During the Treatment Period (up to 8 years)', 'description': 'Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.'}, {'measure': 'Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)', 'timeFrame': 'During the Treatment Period (up to 8 years)', 'description': 'A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.'}], 'secondaryOutcomes': [{'measure': 'Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)', 'timeFrame': 'Baseline, End of Treatment Period (up to 8 years)', 'description': 'Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.\n\nNegative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.'}, {'measure': 'Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)', 'timeFrame': 'Treatment Period (up to 8 years)', 'description': 'At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency'}]}, 'conditionsModule': {'conditions': ['Partial Epilepsies']}, 'referencesModule': {'references': [{'pmid': '25461210', 'type': 'DERIVED', 'citation': 'Rosenfeld W, Fountain NB, Kaubrys G, Ben-Menachem E, McShea C, Isojarvi J, Doty P; SP615 Study Investigators. Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years. Epilepsy Behav. 2014 Dec;41:164-70. doi: 10.1016/j.yebeh.2014.09.074. Epub 2014 Oct 27.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of parent clinical trial for treatment of partial seizures.\n\nExclusion Criteria:\n\n* Receiving any study drug or experimental device other than lacosamide.\n* Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event.'}, 'identificationModule': {'nctId': 'NCT00552305', 'briefTitle': 'To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'An Open-label Extension Trial to Determine Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures', 'orgStudyIdInfo': {'id': 'SP0615'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lacosamide', 'description': '50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing', 'interventionNames': ['Drug: lacosamide']}], 'interventions': [{'name': 'lacosamide', 'type': 'DRUG', 'otherNames': ['Vimpat'], 'description': '50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial', 'armGroupLabels': ['Lacosamide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Ponte Vedra Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.23969, 'lon': -81.38564}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'city': 'Crestview Hills', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 39.02728, 'lon': -84.58494}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Frederick', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Somerset', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.4976, 'lon': -74.48849}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'city': 'Wichita Falls', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.91371, 'lon': -98.49339}}, {'city': 'Bennington', 'state': 'Vermont', 'country': 'United States', 'geoPoint': {'lat': 42.87813, 'lon': -73.19677}}, {'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Bonn', 'country': 'Germany', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Erlangen', 'country': 'Germany', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Kehl Kork', 'country': 'Germany'}, {'city': 'Schwalmstedt-Treysa', 'country': 'Germany'}, {'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Zalaegerszeg', 'country': 'Hungary', 'geoPoint': {'lat': 46.83695, 'lon': 16.84401}}, {'city': 'Kaunas', 'country': 'Lithuania', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Vilnius', 'country': 'Lithuania', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Gothenburg', 'country': 'Sweden', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Stockholm', 'country': 'Sweden', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Bern/Biel', 'country': 'Switzerland'}, {'city': 'Zurich', 'country': 'Switzerland', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Bucks/London', 'country': 'United Kingdom'}, {'city': 'Glasgow', 'country': 'United Kingdom', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}