Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-05 @ 5:24 PM
Study NCT ID:
NCT00546351
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2007-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia and Montenegro']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078334', 'term': 'Lacosamide'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-887-822-9493', 'title': 'UCB (Study Director)', 'organization': 'UCB Clinical Trial Call Center'}, 'certainAgreement': {'otherDetails': 'UCB has \\> 60 but \\<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).', 'description': 'Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.', 'eventGroups': [{'id': 'EG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.', 'otherNumAtRisk': 621, 'otherNumAffected': 169, 'seriousNumAtRisk': 621, 'seriousNumAffected': 132}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 44, 'numAffected': 34}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 63, 'numAffected': 49}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 41, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 49, 'numAffected': 45}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 45, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 45, 'numAffected': 40}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypertensive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Blindness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gastroduodenitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Perforated ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Superinfection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bronchitis fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Tubo-ovarian abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bronchitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Epicondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Traumatic brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'QRS axis abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 12, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Polyarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Toe deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pleural mesothelioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Thyroid adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Epithelioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Oropharyngeal cancer stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Drop attacks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Facial paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Apallic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Brain stem syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Psychosomatic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Snoring', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Neuropathic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Knee operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Coronary arterial stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Transurethral prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vitrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Coronary artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Femoral arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Diabetic macroangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Arterial stenosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 621, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '621', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '416', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From entry Visit 1 through end of treatment (approximately 6.5 years)', 'description': 'Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes all subjects (all 621) in the Safety Set (SS).'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '621', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From entry Visit 1 through end of treatment (approximately 6.5 years)', 'description': 'A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:\n\n* Is fatal\n* Is life-threatening\n* Results in persistent or significant disability/incapacity\n* Requires inpatient hospitalization\n* Prolongs existing inpatient hospitalization\n* Is a congenital anomaly/birth defect\n* Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes all subjects (all 621) in the Safety Set (SS).'}, {'type': 'SECONDARY', 'title': 'Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.45', 'spread': '1.371', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'On the Likert Scale, 0 = no pain and 10 = worst possible pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.\n\nData was not available for 1 subject at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.01', 'spread': '2.246', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last Visit (approximately 2 years)', 'description': 'On the Likert Scale, 0 = no pain and 10 = worst possible pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.\n\nData was not available for 2 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.83', 'spread': '15.986', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 213 are included in this analysis.\n\nData was not available for 408 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.47', 'spread': '23.940', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last Visit (approximately 2 years)', 'description': 'On VAS 0 mm = no pain and 100 mm = worst possible pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 214 are included in this analysis.\n\nData was not available for 407 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': "Patient's Global Impression of Change (PGIC) at Last Visit.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'title': 'Better', 'categories': [{'measurements': [{'value': '82.6', 'groupId': 'OG000'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Last Visit (approximately 2 years)', 'description': 'The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse \\[score of 1\\] to much better \\[score of 7\\]).\n\nReported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 551 are included in this analysis.\n\nData was not available for 70 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '2.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = no pain and 10 = most intense pain sensation imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects of the Safety Set (SS), 195 are included in this analysis.\n\nData was not available for 426 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '2.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not sharp and 10 = most sharp sensation imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.\n\nData was not available for 426 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '2.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not hot and 10 = the most hot sensation imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.\n\nData was not available for 426 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '2.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not cold and 10 = the coldest sensation imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.\n\nData was not available for 426 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '2.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not dull and 10 = most dull sensation imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.\n\nData was not available for 426 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '2.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not unpleasant and 10 = most unpleasant sensation imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.\n\nData was not available for 428 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '2.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = no surface pain and 10 = most intense surface pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.\n\nData was not available for 428 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '2.39', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = no deep pain and 10 = most intense deep pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.\n\nData was not available for 428 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '2.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not itchy and 10 = most itchy sensation imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.\n\nData was not available for 426 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '2.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not sensitive and 10 = most sensitive sensation imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.\n\nData was not available for 426 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.98', 'spread': '1.850', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': '0 = no interference with sleep and 10 = worst possible interference with sleep.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.\n\nData was not available for 1 subject at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.73', 'spread': '2.281', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last Visit', 'description': '0 = no interference with sleep and 10 = worst possible interference with sleep.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.\n\nData was not available for 2 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Average Pain Interference With Activity (11-point Likert Scale) at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '620', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.11', 'spread': '1.660', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': '0 = no interference with activity and 10 = worst possible interference with activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.\n\nData was not available for 1 subject at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.89', 'spread': '2.349', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last Visit', 'description': '0 = no interference with activity and 10 = worst possible interference with activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.\n\nData was not available for 2 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '588', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '8.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis.\n\nData was not available for 33 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '552', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'spread': '9.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last Visit', 'description': 'The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis.\n\nData was not available for 69 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '588', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.8', 'spread': '11.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis.\n\nData was not available for 33 subjects at the time of this measurement.'}, {'type': 'SECONDARY', 'title': 'Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '552', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'spread': '10.90', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Last Visit', 'description': 'The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis.\n\nData was not available for 69 subjects at the time of this measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '621'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '385'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '76'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '109'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Unsatisfactory compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Other reasons for premature termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}]}], 'recruitmentDetails': 'The study started in May 2004 with subjects from Austria, Belgium, Bulgaria, Czech Republic, Finland, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, and United Kingdom. The primary completion date occurred in January 2011, with study completion in January 2011.', 'preAssignmentDetails': 'Participant Flow and Baseline Characteristics refer to the Safety Set (SS).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '621', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '500', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '121', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '9.51', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '296', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '325', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Serbia', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 621}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2007-10-16', 'resultsFirstSubmitDate': '2011-12-21', 'studyFirstSubmitQcDate': '2007-10-17', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-03-26', 'studyFirstPostDateStruct': {'date': '2007-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).', 'timeFrame': 'From entry Visit 1 through end of treatment (approximately 6.5 years)', 'description': 'Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.'}, {'measure': 'Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).', 'timeFrame': 'From entry Visit 1 through end of treatment (approximately 6.5 years)', 'description': 'A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:\n\n* Is fatal\n* Is life-threatening\n* Results in persistent or significant disability/incapacity\n* Requires inpatient hospitalization\n* Prolongs existing inpatient hospitalization\n* Is a congenital anomaly/birth defect\n* Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above'}], 'secondaryOutcomes': [{'measure': 'Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.', 'timeFrame': 'Baseline', 'description': 'On the Likert Scale, 0 = no pain and 10 = worst possible pain.'}, {'measure': 'Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.', 'timeFrame': 'Last Visit (approximately 2 years)', 'description': 'On the Likert Scale, 0 = no pain and 10 = worst possible pain.'}, {'measure': 'Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.', 'timeFrame': 'Baseline', 'description': 'Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.'}, {'measure': 'Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.', 'timeFrame': 'Last Visit (approximately 2 years)', 'description': 'On VAS 0 mm = no pain and 100 mm = worst possible pain.'}, {'measure': "Patient's Global Impression of Change (PGIC) at Last Visit.", 'timeFrame': 'Last Visit (approximately 2 years)', 'description': 'The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse \\[score of 1\\] to much better \\[score of 7\\]).\n\nReported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).'}, {'measure': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit.', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = no pain and 10 = most intense pain sensation imaginable.'}, {'measure': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit.', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not sharp and 10 = most sharp sensation imaginable.'}, {'measure': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit.', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not hot and 10 = the most hot sensation imaginable.'}, {'measure': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit.', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not cold and 10 = the coldest sensation imaginable.'}, {'measure': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit.', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not dull and 10 = most dull sensation imaginable.'}, {'measure': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit.', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not unpleasant and 10 = most unpleasant sensation imaginable.'}, {'measure': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit.', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = no surface pain and 10 = most intense surface pain imaginable.'}, {'measure': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit.', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = no deep pain and 10 = most intense deep pain imaginable.'}, {'measure': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit.', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not itchy and 10 = most itchy sensation imaginable.'}, {'measure': 'Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit.', 'timeFrame': 'Baseline Visit; Last Visit (approximately 2 years)', 'description': '0 = not sensitive and 10 = most sensitive sensation imaginable.'}, {'measure': 'Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.', 'timeFrame': 'Baseline', 'description': '0 = no interference with sleep and 10 = worst possible interference with sleep.'}, {'measure': 'Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.', 'timeFrame': 'Last Visit', 'description': '0 = no interference with sleep and 10 = worst possible interference with sleep.'}, {'measure': 'Average Pain Interference With Activity (11-point Likert Scale) at Baseline.', 'timeFrame': 'Baseline', 'description': '0 = no interference with activity and 10 = worst possible interference with activity.'}, {'measure': 'Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.', 'timeFrame': 'Last Visit', 'description': '0 = no interference with activity and 10 = worst possible interference with activity.'}, {'measure': 'Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline.', 'timeFrame': 'Baseline', 'description': 'The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.'}, {'measure': 'Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit.', 'timeFrame': 'Last Visit', 'description': 'The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.'}, {'measure': 'Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline.', 'timeFrame': 'Baseline', 'description': 'The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.'}, {'measure': 'Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit.', 'timeFrame': 'Last Visit', 'description': 'The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lacosamide'], 'conditions': ['Painful Diabetic Neuropathy']}, 'descriptionModule': {'briefSummary': 'SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who completed Study SP743 (NCT00238524) or SP874 (NCT00350103) and, in the investigator's opinion, might benefit from long-term administration of SP746 (NCT00546351). Exception: subjects who prematurely discontinued\n* SP743 (NCT00238524) or SP874 (NCT00350103) due to lack of efficacy or due to intolerability to trial medication (after Visit 5but prior to entering the Maintenance Phase) may be eligible to participate in SP746 (NCT00546351), after consultation with the medical monitor\n\nExclusion Criteria:\n\n* Subject has clinically relevant ECG abnormalities, or a QTc interval ≥500 ms, and/or a QTc interval increase of ≥60 ms from the mean pre-dose QTc value at Visit 2 of SP743 (NCT00238524) or SP874 (NCT00350103)\n* Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥3 times the upper limit of the normal range (ULN) with total bilirubin ≥2 times ULN or transaminases (AST and/or ALT) ≥5 times ULN\n* Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial\n* Subject is a pregnant or nursing female, or is of childbearing potential and is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception"}, 'identificationModule': {'nctId': 'NCT00546351', 'briefTitle': 'Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Multi-center, Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial.', 'orgStudyIdInfo': {'id': 'SP0746'}, 'secondaryIdInfos': [{'id': '2004-000551-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lacosamide', 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.', 'interventionNames': ['Drug: Lacosamide']}], 'interventions': [{'name': 'Lacosamide', 'type': 'DRUG', 'otherNames': ['Vimpat'], 'description': '50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years', 'armGroupLabels': ['Lacosamide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': '180', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'country': 'Austria', 'facility': '183', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': '003', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Bonheiden', 'country': 'Belgium', 'facility': '006', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'city': 'Genk', 'country': 'Belgium', 'facility': '002', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': '001', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Merksem', 'country': 'Belgium', 'facility': '005', 'geoPoint': 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{'city': 'Győr', 'country': 'Hungary', 'facility': '061', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'city': 'Kecskemét', 'country': 'Hungary', 'facility': '262', 'geoPoint': {'lat': 46.90618, 'lon': 19.69128}}, {'city': 'Makó', 'country': 'Hungary', 'facility': '260', 'geoPoint': {'lat': 46.21667, 'lon': 20.48333}}, {'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': '266', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'city': 'Szeged', 'country': 'Hungary', 'facility': '064', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Székesfehérvár', 'country': 'Hungary', 'facility': '265', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'city': 'Szolnok', 'country': 'Hungary', 'facility': '264', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'city': 'Tatabánya', 'country': 'Hungary', 'facility': '263', 'geoPoint': {'lat': 47.59247, 'lon': 18.38099}}, {'city': 'Veszprém', 'country': 'Hungary', 'facility': '261', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}, {'city': 'Pavia', 'country': 'Italy', 'facility': '270', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Pavia', 'country': 'Italy', 'facility': '273', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Pozzilli', 'country': 'Italy', 'facility': '272', 'geoPoint': {'lat': 41.51142, 'lon': 14.06252}}, {'city': 'Bialystok', 'country': 'Poland', 'facility': '092', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Bialystok', 'country': 'Poland', 'facility': '293', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'city': 'Bydgoszcz', 'country': 'Poland', 'facility': '094', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'city': 'Częstochowa', 'country': 'Poland', 'facility': '095', 'geoPoint': {'lat': 50.79646, 'lon': 19.12409}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': '091', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': '093', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Krakow', 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