Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-06 @ 9:38 AM
Study NCT ID:
NCT01964560
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2013-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
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': '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': {'email': 'UCBCares@ucb.com', 'phone': '001 844 599 2273', 'title': 'UCB', 'organization': 'Cares'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Week 0 to the End of Safety Follow-Up (up to Week 104)', 'description': 'TEAEs were events which started on or after date of first EP0034 dose of LCM, or whose intensity worsened on or after date of first EP0034 dose of LCM. AEs occurring within 30 days after last dose of LCM were considered treatment-emergent. SS included all enrolled study participants who took at least 1 dose of LCM in the long-term extension study.', 'eventGroups': [{'id': 'EG000', 'title': 'Lacosamide (All Subjects)', 'description': 'Participants who participated in primary study \\[SP0967 (NCT02477839) or SP0969 (NCT01921205)\\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \\<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \\>=30 kg to \\<50 kg, and LCM 300 mg/day as tablets for study participants weighing \\>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.', 'otherNumAtRisk': 540, 'deathsNumAtRisk': 540, 'otherNumAffected': 289, 'seriousNumAtRisk': 540, 'deathsNumAffected': 7, 'seriousNumAffected': 111}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 113, 'numAffected': 56}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 54, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 149, 'numAffected': 86}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 167, 'numAffected': 83}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 92, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 68, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 46, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 35, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 42, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 89, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 33, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 49, 'numAffected': 38}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}], 'seriousEvents': [{'term': 'Idiopathic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Cerebral palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Talipes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Parophthalmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Gastrointestinal motility disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Amoebic dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Corona virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Enterovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Pneumonia influenzal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Lip injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Post procedural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Urine output decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Acetonaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Enteral feeding intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Muscle haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Partial seizures with secondary generalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Hypotonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Intracranial haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Motor dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Myoclonic epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Subdural hygroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Tonic convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Emotional disorder of childhood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Pyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Vesicoureteric reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Chylothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Hypoventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Drug reaction with eosinophilia and systemic symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Brain operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 540, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '540', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide (All Subjects)', 'description': 'Participants who participated in primary study \\[SP0967 (NCT02477839) or SP0969 (NCT01921205)\\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \\<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \\>=30 kg to \\<50 kg, and LCM 300 mg/day as tablets for study participants weighing \\>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 0 to the End of Safety Follow-Up (up to Week 104)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set (SS) included all enrolled study participants who took at least 1 dose of LCM in this long-term extension study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '540', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide (All Subjects)', 'description': 'Participants who participated in primary study \\[SP0967 (NCT02477839) or SP0969 (NCT01921205)\\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \\<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \\>=30 kg to \\<50 kg, and LCM 300 mg/day as tablets for study participants weighing \\>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 0 to the End of Safety Follow-Up (up to Week 104)', 'description': 'A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatient hospitalization or prolongation of hospitalization. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SS included all enrolled study participants who took at least 1 dose of LCM in this long-term extension study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With TEAEs Leading to Study Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '540', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide (All Subjects)', 'description': 'Participants who participated in primary study \\[SP0967 (NCT02477839) or SP0969 (NCT01921205)\\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \\<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \\>=30 kg to \\<50 kg, and LCM 300 mg/day as tablets for study participants weighing \\>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 0 to the End of Safety Follow-Up (up to Week 104)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to study discontinuation. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SS included all enrolled study participants who took at least 1 dose of LCM in this long-term extension study. Here, only those participants who discontinued the study due to TEAEs starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose of LCM are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Seizure-free Days During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '537', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide (All Subjects)', 'description': 'Participants who participated in primary study \\[SP0967 (NCT02477839) or SP0969 (NCT01921205)\\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \\<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \\>=30 kg to \\<50 kg, and LCM 300 mg/day as tablets for study participants weighing \\>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.96', 'spread': '36.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Week 0 to End of Treatment (up to Week 96)', 'description': 'The number of seizure-free days was the total number of days within an interval for which daily diary data were available and no seizures were reported. The percentage of seizure-free days was computed as 100 times the number of seizure-free days in the interval divided by the number of days in the interval for which daily diary data were available. Percentage of seizure-free days was measured using data obtained from participant diaries from EP0034 and is presented for the overall Treatment only.', 'unitOfMeasure': 'percentage of seizure free days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) was used for the analysis of seizure data and included all study participants in the SS who had at least 1 completed post-Baseline seizure diary. Study participants whose efficacy data could not be source verified were excluded from the FAS. Here, Number of participants analyzed included those participants who were evaluable for the assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lacosamide (All Subjects)', 'description': 'Participants who participated in primary study \\[SP0967 (NCT02477839) or SP0969 (NCT01921205)\\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \\<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \\>=30 kg to \\<50 kg, and LCM 300 mg/day as tablets for study participants weighing \\>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '540'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '395'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '64'}]}, {'type': 'Surgery-hemispherotomy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Seizures appeared resolved with epilepsy surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Patient and Investigator choice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Patient was prescribed CBD', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Participant moved to another country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study started to enroll participants in August 2014 and concluded in April 2022.', 'preAssignmentDetails': 'The Participant Flow refers to the Safety Set (SS). The SS included all enrolled study participants who took at least 1 dose of lacosamide (LCM) in this long-term extension study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '540', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lacosamide (All Subjects)', 'description': 'Participants who participated in primary study \\[SP0967 (NCT02477839) or SP0969 (NCT01921205)\\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \\<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \\>=30 kg to \\<50 kg, and LCM 300 mg/day as tablets for study participants weighing \\>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.486', 'spread': '5.415', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '>=28 days - <24 months', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}, {'title': '>=24 months - <12 years', 'measurements': [{'value': '287', 'groupId': 'BG000'}]}, {'title': '>=12 - <18 years', 'measurements': [{'value': '150', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '236', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '304', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian/Alaskan native', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '414', 'groupId': 'BG000'}]}]}, {'title': 'Other/mixed', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '472', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics refer to the Safety Set which consisted of all enrolled study participants who took at least 1 dose of LCM in this long-term extension study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-03', 'size': 2339118, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-30T01:44', 'hasProtocol': True}, {'date': '2021-06-03', 'size': 2002530, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-30T01:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 540}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03559673', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2013-10-14', 'resultsFirstSubmitDate': '2022-09-30', 'studyFirstSubmitQcDate': '2013-10-14', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-30', 'studyFirstPostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From Week 0 to the End of Safety Follow-Up (up to Week 104)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.'}, {'measure': 'Percentage of Participants With Serious TEAEs', 'timeFrame': 'From Week 0 to the End of Safety Follow-Up (up to Week 104)', 'description': 'A serious adverse event (SAE) must meet 1 or more of the following criteria: • Death, • Life-threatening (Life-threatening does not include a reaction that might have caused death had it occurred in a more severe form.), • Significant or persistent disability/incapacity, • Congenital anomaly/birth defect (including that occurring in a fetus), • Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious., • Initial inpatient hospitalization or prolongation of hospitalization. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.'}, {'measure': 'Percentage of Participants With TEAEs Leading to Study Discontinuation', 'timeFrame': 'From Week 0 to the End of Safety Follow-Up (up to Week 104)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to study discontinuation. Treatment-emergent is defined as starting on or after the date of first dose of LCM in EP0034, and within 30 days of last dose.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Seizure-free Days During the Study', 'timeFrame': 'From Week 0 to End of Treatment (up to Week 96)', 'description': 'The number of seizure-free days was the total number of days within an interval for which daily diary data were available and no seizures were reported. The percentage of seizure-free days was computed as 100 times the number of seizure-free days in the interval divided by the number of days in the interval for which daily diary data were available. Percentage of seizure-free days was measured using data obtained from participant diaries from EP0034 and is presented for the overall Treatment only.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lacosamide', 'Vimpat', 'UCB', 'Epilepsy', 'Partial-Onset Seizures', 'Pediatric'], 'conditions': ['Epilepsy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ucb.com/_up/ucb_com_products/documents/Vimpat_Labeling_Oct_2021.pdf', 'label': 'Product Information'}, {'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors\n* Subject has completed the Transition Period of SP0967 \\[NCT02477839\\] or SP0969 \\[NCT01921205\\] for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy\n* Subject is expected to benefit from participation, in the opinion of the investigator\n* Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator\n* Subject is male or female aged 1 month to ≤17 years\n* Subject has a diagnosis of epilepsy with partial-onset seizures\n\nExclusion Criteria:\n\n* Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)\n* Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing serious adverse event (SAE)\n* For subjects ≥6 years of age, subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1\n* Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception"}, 'identificationModule': {'nctId': 'NCT01964560', 'briefTitle': 'A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Multicenter, Open-label, Long-term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects With Epilepsy With Partial-Onset Seizures', 'orgStudyIdInfo': {'id': 'EP0034'}, 'secondaryIdInfos': [{'id': '2012-005012-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lacosamide', 'description': 'In the first week after enrollment into EP0034 subjects will be dosed according to their weight:\n\n* Lacosamide (LCM) 10 mg/kg/day (oral solution) for subjects weighing \\<30 kg\n* LCM 6 mg/kg/day (oral solution) for subjects weighing ≥30 kg to \\<50 kg\n* LCM 300 mg/day (tablets) for subjects weighing ≥50 kg\n\nAfter 1 week the investigator may adjust the LCM dose during the Treatment Period based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.', 'interventionNames': ['Drug: Lacosamide']}], 'interventions': [{'name': 'Lacosamide', 'type': 'DRUG', 'otherNames': ['VIMPAT'], 'description': 'Pharmaceutical form: oral solution\n\nConcentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day)\n\nRoute of administration: oral use', 'armGroupLabels': ['Lacosamide']}, {'name': 'Lacosamide', 'type': 'DRUG', 'otherNames': ['VIMPAT'], 'description': 'Pharmaceutical form: tablet\n\nConcentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day)\n\nRoute of administration: oral use', 'armGroupLabels': ['Lacosamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233-1711', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Ep0034 638', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '32819', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Ep0034 105', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Ep0034 117', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '40536-0284', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Ep0034 124', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Ep0034 115', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Ep0034 120', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Ep0034 102', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '97477', 'city': 'Springfield', 'state': 'Oregon', 'country': 'United States', 'facility': 'Ep0034 640', 'geoPoint': {'lat': 44.04624, 'lon': -123.02203}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Ep0034 129', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Ep0034 630', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98105-0371', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Ep0034 114', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Ciudad Autonoma de Buenos AIRE', 'country': 'Argentina', 'facility': 'Ep0034 143'}, {'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Ep0034 142', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': 'Ep0034 200', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Parkville', 'country': 'Australia', 'facility': 'Ep0034 203', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'South Brisbane', 'country': 'Australia', 'facility': 'Ep0034 205', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Ep0034 304', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Passo Fundo', 'country': 'Brazil', 'facility': 'Ep0034 158', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Ep0034 150', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Ep0034 154', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Ep0034 310', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Ep0034 530', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'country': 'China', 'facility': 'Ep0034 535', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'Ep0034 532', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Nanchang', 'country': 'China', 'facility': 'Ep0034 536', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Ep0034 531', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenzhen', 'country': 'China', 'facility': 'Ep0034 537', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Medellín', 'country': 'Colombia', 'facility': 'Ep0034 171', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'city': 'Osijek', 'country': 'Croatia', 'facility': 'Ep0034 613', 'geoPoint': {'lat': 45.55066, 'lon': 18.6942}}, {'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Ep0034 610', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Ep0034 612', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Ep0034 321', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Ostrava-poruba', 'country': 'Czechia', 'facility': 'Ep0034 320'}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Ep0034 323', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Praha 4 - KRC', 'country': 'Czechia', 'facility': 'Ep0034 322'}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Ep0034 331', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tartu', 'country': 'Estonia', 'facility': 'Ep0034 330', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Ep0034 346', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Ep0034 344', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Ep0034 620', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Ep0034 621', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Ep0034 622', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Ep0034 623', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Ep0034 542', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Ep0034 361', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Ep0034 362', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Ep0034 363', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Ep0034 364', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Ep0034 368', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Ep0034 360', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Miskolc', 'country': 'Hungary', 'facility': 'Ep0034 367', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'city': 'Pécs', 'country': 'Hungary', 'facility': 'Ep0034 366', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Ep0034 374', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Ep0034 397', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Mantova', 'country': 'Italy', 'facility': 'Ep0034 380', 'geoPoint': {'lat': 45.16031, 'lon': 10.79784}}, {'city': 'Messina', 'country': 'Italy', 'facility': 'Ep0034 398', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ep0034 381', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'Ep0034 393', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Ep0034 383', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Ep0034 392', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Ep0034 395', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Verona', 'country': 'Italy', 'facility': 'Ep0034 386', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Riga', 'country': 'Latvia', 'facility': 'Ep0034 400', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Valmiera', 'country': 'Latvia', 'facility': 'Ep0034 402', 'geoPoint': {'lat': 57.54108, 'lon': 25.42751}}, {'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Ep0034 411', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Aguascalientes', 'country': 'Mexico', 'facility': 'Ep0034 694', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'city': 'Culiacán', 'country': 'Mexico', 'facility': 'Ep0034 569', 'geoPoint': {'lat': 24.80209, 'lon': -107.39421}}, {'city': 'Culiacán', 'country': 'Mexico', 'facility': 'Ep0034 693', 'geoPoint': {'lat': 24.80209, 'lon': -107.39421}}, {'city': 'Guadalajara', 'country': 'Mexico', 'facility': 'Ep0034 563', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'city': 'México', 'country': 'Mexico', 'facility': 'Ep0034 564', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Monterrey', 'country': 'Mexico', 'facility': 'Ep0034 568', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Ep0034 650', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'city': 'Podgorica', 'country': 'Montenegro', 'facility': 'Ep0034 660', 'geoPoint': {'lat': 42.44124, 'lon': 19.26309}}, {'city': 'Cebu', 'country': 'Philippines', 'facility': 'Ep0034 724', 'geoPoint': {'lat': 16.75187, 'lon': 121.5961}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'Ep0034 721', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'Ep0034 433', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Kielce', 'country': 'Poland', 'facility': 'Ep0034 420', 'geoPoint': {'lat': 50.87033, 'lon': 20.62752}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Ep0034 422', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Ep0034 431', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Ep0034 423', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Ep0034 425', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Tyniec Mały', 'country': 'Poland', 'facility': 'Ep0034 429', 'geoPoint': {'lat': 51.01948, 'lon': 16.91998}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Ep0034 430', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Ep0034 428', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Ep0034 750', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Ep0034 574', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Ep0034 581', 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18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.', 'accessCriteria': 'Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB BIOSCIENCES, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'UCB Biopharma SRL', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}