Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT00438451
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2007-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs
Sponsor:
Organization:
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': 'D000077287', 'term': 'Levetiracetam'}, {'id': 'D002220', 'term': 'Carbamazepine'}, {'id': 'D000077213', 'term': 'Lamotrigine'}], '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'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D014227', 'term': 'Triazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ruckes@izks-mainz.de', 'phone': '+49 (0) 6131 17', 'title': 'C. Ruckes', 'phoneExt': '9919', 'organization': 'Interdisciplinary Center for Clinical Trials (IZKS Mainz)'}, 'certainAgreement': {'otherDetails': 'This study was supported (as investigator-initated trial) by an educational grant from UCB GmbH, Germany. A disclosure restriction applies on the PI in that UCB can review results communications prior to public release and can embargo communications regarding trial results for a period of 90 days from the time submitted. As of Jan-01-2012 the study chair is an employee to UCB Biosciences GmbH working as Medical Director in the Therapeutic Area CNS within Global Projects and Development.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded from day 1 of treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg', 'otherNumAtRisk': 122, 'otherNumAffected': 108, 'seriousNumAtRisk': 122, 'seriousNumAffected': 33}, {'id': 'EG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg', 'otherNumAtRisk': 121, 'otherNumAffected': 108, 'seriousNumAtRisk': 121, 'seriousNumAffected': 36}, {'id': 'EG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg', 'otherNumAtRisk': 117, 'otherNumAffected': 110, 'seriousNumAtRisk': 117, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 23, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 48, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 51, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 29, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 26, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 23, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 52, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 35, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 44, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 35, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 22, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 46, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 39, 'numAffected': 29}, 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'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 5, 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'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute mycardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 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'MedDRA 14.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastric ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 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'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Complex partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 2, 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'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 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'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Stupor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 121, 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'MedDRA 14.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bursa removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Meningioma surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Radiotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Temporal arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg'}, {'id': 'OG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000', 'lowerLimit': '0.53', 'upperLimit': '0.70'}, {'value': '0.46', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '0.55'}, {'value': '0.56', 'groupId': 'OG002', 'lowerLimit': '0.47', 'upperLimit': '0.65'}]}]}], 'analyses': [{'pValue': '0.0201', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1536', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3615', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0478', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0578', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.838', 'ciLowerLimit': '1.092', 'ciUpperLimit': '3.093', 'estimateComment': 'Odds ratio given here is for comparison "LEV vs CBZ": OR=1.838 KI=(1.092-3.093) "LEV vs LTG": OR=1.169 KI=(0.689-1.984) "CBZ vs LTG": OR=0.636 KI=(0.377-1.073) "Number of concurrent diseases": OR=0.921 KI=(0.859-0.987)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for treatment (p=0.0578), country (p=0.4649), pooled sites (p=0.4420) and number of concurrent diseases (p=0.0192)', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '58 weeks', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population:\n\nAll randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements.'}, {'type': 'SECONDARY', 'title': 'Time to Drop Out', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg'}, {'id': 'OG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'less than 50% of patients dropped out', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '265', 'comment': 'not enough patients dropped out', 'groupId': 'OG001', 'lowerLimit': '119', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'less than 50% of patients dropped out', 'groupId': 'OG002', 'lowerLimit': '270', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0596', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '58 weeks', 'description': 'number of days between randomization and premature discontinuation of the study', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population:\n\nAll randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg'}, {'id': 'OG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2517', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 30', 'description': 'Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population:\n\nAll randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg'}, {'id': 'OG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3303', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'week 58', 'description': 'Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population:\n\nAll randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements.'}, {'type': 'SECONDARY', 'title': 'The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg'}, {'id': 'OG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'could not be estimated since there were less than 50% events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'could not be estimated since there were less than 50% events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'could not be estimated since there were less than 50% events', 'groupId': 'OG002', 'lowerLimit': '308', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.5022', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'over the whole duration of 58 weeks', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population:\n\nAll randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements.'}, {'type': 'SECONDARY', 'title': 'The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg'}, {'id': 'OG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg'}], 'classes': [{'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'over 52 weeks', 'description': 'Seizure frequency was assessed by investigators in the CRF at the Visits V3, V4, V5 and V6.\n\nThe absolute seizure frequency during the maintenance phase was defined as the sum of those entries.', 'unitOfMeasure': 'number of seizures', 'reportingStatus': 'POSTED', 'populationDescription': 'Completer population:\n\nThe completer population comprises all patients still being in the study at week 58 (This definition deviates minimally from the protocol. It could not be assessed from the CRF data, if patients were on treatment).'}, {'type': 'SECONDARY', 'title': 'Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg'}, {'id': 'OG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000'}, {'value': '0.99', 'groupId': 'OG001'}, {'value': '0.99', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'unitOfMeasure': 'proportion of seizure-free days', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients of ITT population who reached the maintenance phase'}, {'type': 'SECONDARY', 'title': 'QOLIE-31 (Quality Of Life In Epilepsy) Results at V6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg'}, {'id': 'OG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg'}], 'classes': [{'title': 'Seizure worry', 'categories': [{'measurements': [{'value': '85.1', 'spread': '19.89', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '100'}, {'value': '75.4', 'spread': '26.87', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '75.0', 'spread': '26.26', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Overall quality of life', 'categories': [{'measurements': [{'value': '67.2', 'spread': '21.76', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '100'}, {'value': '65.0', 'spread': '20.65', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '100'}, {'value': '67.1', 'spread': '20.96', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '100'}]}]}, {'title': 'Emotional well-being', 'categories': [{'measurements': [{'value': '72.0', 'spread': '19.42', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '100'}, {'value': '69.8', 'spread': '18.76', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '100'}, {'value': '67.4', 'spread': '20.25', 'groupId': 'OG002', 'lowerLimit': '16', 'upperLimit': '100'}]}]}, {'title': 'Energy/fatigue', 'categories': [{'measurements': [{'value': '60.8', 'spread': '21.03', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '100'}, {'value': '54.5', 'spread': '21.33', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '95'}, {'value': '59.8', 'spread': '22.07', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '100'}]}]}, {'title': 'Cognitive functioning', 'categories': [{'measurements': [{'value': '75.1', 'spread': '19.48', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '100'}, {'value': '68.9', 'spread': '20.96', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '100'}, {'value': '68.0', 'spread': '21.11', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '100'}]}]}, {'title': 'Medication effects', 'categories': [{'measurements': [{'value': '77.6', 'spread': '26.78', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '70.6', 'spread': '28.21', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '72.6', 'spread': '30.34', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Social functioning', 'categories': [{'measurements': [{'value': '81.1', 'spread': '19.23', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '100'}, {'value': '76.3', 'spread': '25.49', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '100'}, {'value': '76.7', 'spread': '24.28', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '100'}]}]}, {'title': 'Total Score', 'categories': [{'measurements': [{'value': '73.9', 'spread': '15.89', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '100'}, {'value': '68.9', 'spread': '17.80', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '96'}, {'value': '69.1', 'spread': '17.12', 'groupId': 'OG002', 'lowerLimit': '17', 'upperLimit': '96'}]}]}, {'title': 'Health Scale', 'categories': [{'measurements': [{'value': '69.5', 'spread': '19.28', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '100'}, {'value': '65.7', 'spread': '21.21', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '100'}, {'value': '67.5', 'spread': '19.84', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '58 weeks, final visit', 'description': 'The QOLIE-31 is a 31 item score that measures the quality of life in epilepsy (each item with a range of 0 to 100). There are 7 sub-scores seizure worry (items 11,21,22,23,25), overall quality of life (items 1,14), emotional well-being (items 3,4,5,7,9), energy/fatigue (items 2,6,8,10), cognitive functioning (items 12,15,16,17,18,26), medication effects (items 24,29,30) and social functioning (13,19,20,27,28). These scores were combined to a total score by Total score = seizure worry\\*0.08 + overall quality of life\\*0.14 + emotional well-being\\*0.15 + energy/fatigue\\*0.12 + cognitive functioning\\*0.27 + medication effects\\*0.03 + social functioning\\*0.21 For all scores, higher values indicate better quality of life. Each score has a possible range from 0 to 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients of ITT population who filled out QOLIE-31 at V6'}, {'type': 'SECONDARY', 'title': 'Portland Neurotoxicity Scale (PNS) at V6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg'}, {'id': 'OG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg'}], 'classes': [{'title': 'Cognitive toxicity subscore', 'categories': [{'measurements': [{'value': '22.2', 'spread': '12.52', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '79'}, {'value': '27.3', 'spread': '15.71', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '82'}, {'value': '23.7', 'spread': '11.44', 'groupId': 'OG002', 'lowerLimit': '10', 'upperLimit': '66'}]}]}, {'title': 'Somatomotor subscore', 'categories': [{'measurements': [{'value': '10.5', 'spread': '5.53', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '28'}, {'value': '11.4', 'spread': '6.96', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '35'}, {'value': '10.8', 'spread': '5.42', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '31'}]}]}, {'title': 'Total Score', 'categories': [{'measurements': [{'value': '32.7', 'spread': '16.81', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '107'}, {'value': '38.7', 'spread': '21.73', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '110'}, {'value': '34.5', 'spread': '15.67', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '83'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at week 58', 'description': 'The PNS is a 15-item scale. Each item can be scored from 1 to 9. There are a total score (includes all items, range:15 to 135) and two subscores: The cognitive toxicity subscore (10 items: Energy Level, Memory, Interest, Concentration, Forgetfulness, Sleepliness, Moodiness, Alertness, Attention Span, Motivation, range:10 to 90) and the somatomoto subscore (5 items: Vision, Walking, Coordination, Tremor, Speech, range:5-45). The score is calculated by taking the mean of all non-missing values times the number of items.\n\nLower values indicate better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients of ITT population who filled out PNS at V6'}, {'type': 'SECONDARY', 'title': 'Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg'}, {'id': 'OG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg'}], 'classes': [{'categories': [{'measurements': [{'value': '26.0', 'spread': '7.22', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '38'}, {'value': '26.0', 'spread': '7.05', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '39'}, {'value': '25.4', 'spread': '6.82', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '39'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 58', 'description': 'EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. The results of EPITrack Score ranges between 7 and 45.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients of ITT population who had data at V6'}, {'type': 'SECONDARY', 'title': 'Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg'}, {'id': 'OG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg'}], 'classes': [{'title': 'Without pathological findings', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Borderline', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Impaired', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '58 weeks', 'description': 'Evaluation of current testing at V6:\n\n≥29 score points: Inconspicuous; 26 to 28 score points: Borderline;\n\n≤25 score points: Impaired', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients of ITT population with data at V6'}, {'type': 'SECONDARY', 'title': 'Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg'}, {'id': 'OG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg'}, {'id': 'OG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Unchanged', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 58', 'description': 'Evaluation of Changes\n\nChanges in the EpiTrack® Score were categorized as follows:\n\n≥5 score points: Improved;\n\n-3 to 4 score points: Unchanged;\n\n≤-4 score points: Worsened', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients of ITT population with data at V6 and V0'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg: capsules, each containing one Levetiracetam 250mg film-coated tablet.\n\nDuring titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed.'}, {'id': 'FG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg: capsules, each containing half of one Carbamazepine 200mg slow release tablet.\n\nDuring titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed.'}, {'id': 'FG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg: capsules, each containing one Lamotrigine 25mg tablet. During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '121'}, {'groupId': 'FG002', 'numSubjects': '118'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '121'}, {'groupId': 'FG002', 'numSubjects': '117'}]}, {'type': 'ITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '117'}]}, {'type': 'Maintenance Phase (Week 7-58)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '53'}]}]}], 'recruitmentDetails': '43 study centres in three countries participated in this study (31 in Germany, 5 in Austria, 7 in Switzerland). The number of patients recruited in each country (242 Germany, 55 Austria, 29 Switzerland) and per centre (range from 1 to 53) was heterogeneous.\n\nTherefore, centre effects were explored by pooling the centres with less than 20 subjects.', 'preAssignmentDetails': 'In total, 361 patients were randomized. 359 patients were analysed ITT (patient 0213 did not suffer from epilepsy, patient 3604 should not have been asked for informed consent, because of his legal guardianship).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Levetiracetam', 'description': 'Levetiracetam 250mg'}, {'id': 'BG001', 'title': 'Carbamazepine', 'description': 'Carbamazepine 100mg'}, {'id': 'BG002', 'title': 'Lamotrigine', 'description': 'Lamotrigine 25mg'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.8', 'spread': '7.49', 'groupId': 'BG000'}, {'value': '71.7', 'spread': '6.66', 'groupId': 'BG001'}, {'value': '70.7', 'spread': '7.43', 'groupId': 'BG002'}, {'value': '71.4', 'spread': '7.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Age is shown for ITT population', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '215', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender is shown for ITT population', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race is shown for ITT population', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '278', 'groupId': 'BG003'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Region of enrollment is shown for ITT population', 'unitOfMeasure': 'participants'}, {'title': 'Epilepsy history - number of seizures', 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '9.85', 'groupId': 'BG000'}, {'value': '4.8', 'spread': '10.78', 'groupId': 'BG001'}, {'value': '2.7', 'spread': '3.14', 'groupId': 'BG002'}, {'value': '3.75', 'spread': '8.69', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'is shown for ITT population', 'unitOfMeasure': 'number of seizures', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Epilepsy history - Aura', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '286', 'groupId': 'BG003'}]}]}, {'title': 'NA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'is shown for ITT population "NA" refer to the fact that the epilepsy history - Aura is unknown', 'unitOfMeasure': 'participants'}, {'title': 'Epilepsy history - Autonomic seizure', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '356', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'is shown for ITT population', 'unitOfMeasure': 'participants'}, {'title': 'Epilepsy history - Dialeptic seizure', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '313', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'is shown for ITT population', 'unitOfMeasure': 'participants'}, {'title': 'Epilepsy history - Motor seizure', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '291', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'is shown for ITT population', 'unitOfMeasure': 'participants'}, {'title': 'Epileptic history - Special seizure', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '326', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'is shown for ITT population', 'unitOfMeasure': 'participants'}, {'title': 'EEG (electroencephalogram) pathological', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '241', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'is shown for ITT population', 'unitOfMeasure': 'participants'}, {'title': 'MRT (Magnetic Resonance Tomograhy) pathological', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'is shown for ITT population', 'unitOfMeasure': 'participants'}, {'title': 'CCT (Cranial Computed Tomography) pathological', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'is shown for ITT population', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 361}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-24', 'studyFirstSubmitDate': '2007-02-21', 'resultsFirstSubmitDate': '2012-09-24', 'studyFirstSubmitQcDate': '2007-02-21', 'lastUpdatePostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-24', 'studyFirstPostDateStruct': {'date': '2007-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment', 'timeFrame': '58 weeks'}], 'secondaryOutcomes': [{'measure': 'Time to Drop Out', 'timeFrame': '58 weeks', 'description': 'number of days between randomization and premature discontinuation of the study'}, {'measure': 'Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4)', 'timeFrame': 'Week 30', 'description': 'Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30.'}, {'measure': 'Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6)', 'timeFrame': 'week 58', 'description': 'Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58.'}, {'measure': 'The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment)', 'timeFrame': 'over the whole duration of 58 weeks'}, {'measure': 'The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58)', 'timeFrame': 'over 52 weeks', 'description': 'Seizure frequency was assessed by investigators in the CRF at the Visits V3, V4, V5 and V6.\n\nThe absolute seizure frequency during the maintenance phase was defined as the sum of those entries.'}, {'measure': 'Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase', 'timeFrame': '52 weeks'}, {'measure': 'QOLIE-31 (Quality Of Life In Epilepsy) Results at V6', 'timeFrame': '58 weeks, final visit', 'description': 'The QOLIE-31 is a 31 item score that measures the quality of life in epilepsy (each item with a range of 0 to 100). There are 7 sub-scores seizure worry (items 11,21,22,23,25), overall quality of life (items 1,14), emotional well-being (items 3,4,5,7,9), energy/fatigue (items 2,6,8,10), cognitive functioning (items 12,15,16,17,18,26), medication effects (items 24,29,30) and social functioning (13,19,20,27,28). These scores were combined to a total score by Total score = seizure worry\\*0.08 + overall quality of life\\*0.14 + emotional well-being\\*0.15 + energy/fatigue\\*0.12 + cognitive functioning\\*0.27 + medication effects\\*0.03 + social functioning\\*0.21 For all scores, higher values indicate better quality of life. Each score has a possible range from 0 to 100.'}, {'measure': 'Portland Neurotoxicity Scale (PNS) at V6', 'timeFrame': 'at week 58', 'description': 'The PNS is a 15-item scale. Each item can be scored from 1 to 9. There are a total score (includes all items, range:15 to 135) and two subscores: The cognitive toxicity subscore (10 items: Energy Level, Memory, Interest, Concentration, Forgetfulness, Sleepliness, Moodiness, Alertness, Attention Span, Motivation, range:10 to 90) and the somatomoto subscore (5 items: Vision, Walking, Coordination, Tremor, Speech, range:5-45). The score is calculated by taking the mean of all non-missing values times the number of items.\n\nLower values indicate better quality of life.'}, {'measure': 'Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6', 'timeFrame': 'week 58', 'description': 'EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. The results of EPITrack Score ranges between 7 and 45.'}, {'measure': 'Results of Cognitive Testing (EpiTrack© by UCB) - Categories at V6', 'timeFrame': '58 weeks', 'description': 'Evaluation of current testing at V6:\n\n≥29 score points: Inconspicuous; 26 to 28 score points: Borderline;\n\n≤25 score points: Impaired'}, {'measure': 'Results of Cognitive Testing (EpiTrack© by UCB) - Changes to Baseline (V0) at Week 58 (V6)', 'timeFrame': 'week 58', 'description': 'Evaluation of Changes\n\nChanges in the EpiTrack® Score were categorized as follows:\n\n≥5 score points: Improved;\n\n-3 to 4 score points: Unchanged;\n\n≤-4 score points: Worsened'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['elderly', 'focal epilepsy', 'anticonvulsive', 'treatment', 'levetiracetam', 'lamotrigine', 'carbamazepine'], 'conditions': ['Focal Epilepsy']}, 'referencesModule': {'references': [{'pmid': '15955935', 'type': 'BACKGROUND', 'citation': 'Rowan AJ, Ramsay RE, Collins JF, Pryor F, Boardman KD, Uthman BM, Spitz M, Frederick T, Towne A, Carter GS, Marks W, Felicetta J, Tomyanovich ML; VA Cooperative Study 428 Group. New onset geriatric epilepsy: a randomized study of gabapentin, lamotrigine, and carbamazepine. Neurology. 2005 Jun 14;64(11):1868-73. doi: 10.1212/01.WNL.0000167384.68207.3E.'}, {'pmid': '12199724', 'type': 'BACKGROUND', 'citation': 'Brodie MJ, Chadwick DW, Anhut H, Otte A, Messmer SL, Maton S, Sauermann W, Murray G, Garofalo EA; Gabapentin Study Group 945-212. Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy. Epilepsia. 2002 Sep;43(9):993-1000. doi: 10.1046/j.1528-1157.2002.45401.x.'}, {'pmid': '25684224', 'type': 'DERIVED', 'citation': 'Werhahn KJ, Trinka E, Dobesberger J, Unterberger I, Baum P, Deckert-Schmitz M, Kniess T, Schmitz B, Bernedo V, Ruckes C, Ehrlich A, Kramer G. A randomized, double-blind comparison of antiepileptic drug treatment in the elderly with new-onset focal epilepsy. Epilepsia. 2015 Mar;56(3):450-9. doi: 10.1111/epi.12926. Epub 2015 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'In this clinical trial patients with newly diagnosed focal epilepsy aged 60 years or older receive three different antiepileptic drugs in a double-blind, randomized design over a period of 58 weeks. All drugs are licensed for the treatment of epilepsy. The primary endpoint of this study will be retention rate at 58-weeks, since it reflects both efficacy and tolerability.', 'detailedDescription': 'Indication: Focal Epilepsy Objectives: To evaluate the tolerability and efficacy of levetiracetam (LEV) in newly diagnosed elderly patients (aged 60 yrs or above) with focal epilepsy compared to lamotrigine (LTG) or carbamazepine slow release (CBZ).\n\nPrimary Outcome: The primary outcome will be the 58-week retention rate measured by the number of drop outs due to adverse events or seizures from day 1 of treatment.\n\nSecondary Outcome: Proportion of patients remaining seizure-free at week 30 (Visit 4); proportion of patients remaining seizure free at week 58 (Visit 6); the time (in days) to first break-through seizure (from day 1 of treatment); the absolute seizure frequency during the maintenance (over 52 weeks) phase; proportion of seizure-free days during the maintenance phase for subjects who enter the maintenance phase; the frequency of adverse events (from day 1 of treatment); QOLIE-31 results at V6; Portland Neurotoxicity scale at V6; results of cognitive testing (EpiTrack© by UCB).\n\nTrial Design: This is a randomized, double-blind, multicenter Phase IV study using a parallel group design with three treatment groups. The study will consist of a 6-week titration-phase and a 52-week maintenance phase. Patients who successfully complete the trial (final visit, V6) will be unblinded and offered either to continue on their current drug or be changed to an alternative antiepileptic drug (AED) treatment of choice.\n\nPopulation: Patients aged 60 years or above with new onset focal epilepsy i.e. either at least one epileptic seizure in the last 6 months and focal epileptiform discharges on EEG or a relevant lesion on CT/MRI or a total of 2 epileptic seizures, one of which occurring in the last 6 months prior inclusion. Patients with acute (\\< 2 weeks) symptomatic epileptic seizures due to acute brain abnormalities (i.e. haemorrhage or cerebral infarct), or contraindications against any of the drugs in trial will be excluded.\n\nSample Size: 360 patients to be included, 120 patients per treatment arm. Investigational Medicinal Product(s): Levetiracetam, lamotrigine, carbamazepine-slow release Trial Duration and Dates: Duration of treatment: 6 weeks titration phase, 52 weeks maintenance phase.\n\nFollow up: At the end of trial subjects will be unblinded and may choose to continue on the medication or taper the trial medication and be treated with an alternative drug at the investigators discretion. The patient will receive a dosing schedule and a referral letter for his/her physician.\n\nDuration of trial: approximately 2 years. Start of recruitment: January 2007 Projected number of centres: 75 Number of countries: 3 (Germany, Switzerland, Austria).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 60 yrs or above.\n* New onset focal epilepsy i.e. either at least one epileptic seizure in the last 6 months and focal epileptiform discharges on EEG or a relevant lesion on CT/MRI or at least 2 epileptic seizures, one of which occurring in the last 6 months prior inclusion.\n* No previous AED treatment, except for a period not longer than 4 weeks prior to inclusion (V0).\n* Ability of subject to understand verbal and written instructions, to comply with all study requirements, and to comprehend character and individual consequences of the clinical trial.\n* Written informed consent before enrolment in the trial.\n\nExclusion Criteria:\n\n* Acute symptomatic epileptic seizures occurring acutely within a 2 week period after the onset of an acute illness such as cerebral haemorrhage, cerebral infarct, rapid progressive malignancy or other acute brain abnormalities (i.e. encephalitis, hypoxic brain damage, trauma, metabolic derangement, following brain surgery).\n* Dementia (as defined by history)\n* Renal insufficiency as defined by GFR \\< 50 mL/min.\n* Increased liver enzymes (GOT, GPT, gGT) or increased bilirubin ≥ 2-fold the upper limit of normal (ULN).\n* Pre-treatment with valproic acid within the four weeks prior inclusion (V0).\n* Contraindication against or history of hypersensitivity to any of the investigational medicinal products or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal products.\n* Participation in other clinical trials and observation period of competing trials within the last 2 months, respectively.\n* History of drug or alcohol abuse within the last 2 years.\n* Medical condition which interferes with the participation in the trial according to the opinion of the investigator.\n* Patients with life expectancy \\< 1 year due to malignant disease\n* Psychiatric morbidity requiring legal guardianship.'}, 'identificationModule': {'nctId': 'NCT00438451', 'acronym': 'STEP-ONE', 'briefTitle': 'Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'A Multicentre, Double-blind, Randomized, Phase IV Clinical Trial Comparing the Safety, Tolerability and Efficacy of Levetiracetam Versus Lamotrigine and Carbamazepine in the Oral Antiepileptic Therapy of Newly Diagnosed Elderly Patients With Focal Epilepsy.', 'orgStudyIdInfo': {'id': 'STEPONE05'}, 'secondaryIdInfos': [{'id': 'ISRCTN: 94839639'}, {'id': 'EudraCT Number:2005-003324-19'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levetiracetam', 'description': 'Levetiracetam', 'interventionNames': ['Drug: Levetiracetam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carbamazepine', 'description': 'Carbamazepine', 'interventionNames': ['Drug: Carbamazepine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lamotrigine', 'description': 'Lamotrigine', 'interventionNames': ['Drug: Lamotrigine']}], 'interventions': [{'name': 'Levetiracetam', 'type': 'DRUG', 'description': 'LEV 250 mg capusles: week 1 and 2 0-0-1, week 3 and 4 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (500 - 3000 mg)during maintenance.', 'armGroupLabels': ['Levetiracetam']}, {'name': 'Carbamazepine', 'type': 'DRUG', 'description': 'CBZ 100 mg capusles: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 per day (200 - 1200 mg) during maintenance depending on tolerance and efficacy.', 'armGroupLabels': ['Carbamazepine']}, {'name': 'Lamotrigine', 'type': 'DRUG', 'description': 'LTG 25 mg encapsulated: week 1 and 2: 0-0-1, week 3 and 4: 1-0-1, week 5: 1-0-2, week 6: 2-0-2. Patients may take 2 to 12 caps. per day (50 - 300 mg)during maintenance depending on tolerance and efficacy.', 'armGroupLabels': ['Lamotrigine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55101', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Department of Neurology, University of Mainz Medical Centre', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Konrad J Werhahn, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Johannes Gutenberg University, Department od Neurology'}, {'name': 'Günter Kraemer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Swiss Epilepy Centre'}, {'name': 'Eugen Trinka, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University of Salzburg, Department of Neurology, Austria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'collaborators': [{'name': 'UCB Pharma GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof of Neurology, Head Section on Epilepsy', 'investigatorFullName': 'Konrad J. Werhahn', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}