Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-09 @ 7:36 PM
Study NCT ID:
NCT00280059
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2006-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D000077213', 'term': 'Lamotrigine'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014227', 'term': 'Triazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Cox proportional hazards model for time to event (TTE) analyses; three summary statistics were not generated as median TTE will not exist if survival function (Kaplan-Meier product limit estimates) does not fall below 0.5 (post-hoc analysis).'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.', 'otherNumAtRisk': 330, 'otherNumAffected': 186, 'seriousNumAtRisk': 330, 'seriousNumAffected': 44}, {'id': 'EG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.', 'otherNumAtRisk': 330, 'otherNumAffected': 171, 'seriousNumAtRisk': 330, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 47}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 73}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Multiple endocrine adenomatosis Type II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Parathyroid gland enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Entropion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Trichiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sudden unexplained death in epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vulvovaginitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Muscle haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Trigger finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'T-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': "Waldenstrom's macroglobulinaemia", 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Drug withdrawal convulsions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Partial seizures with secondary generalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Postictal headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Spinal cord disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': "Wernicke's encephalopathy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Conversion disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Delirium tremens', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vulval oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vocal cord cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Toxic epidermal necrolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Carpal tunnel decompression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ostectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Splenectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}, {'value': '67.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '-0.09', 'estimateComment': '95% confidence interval for the true difference in proportions, as well as a one-sided test at α=0.025; confidence interval adjusted for centers clustered within a geographical region, with upper and lower confidence limits.', 'groupDescription': 'Analysis of the binary response variable for 6 consecutive months seizure freedom analyzed by comparing the proportions of favorable responders between the two treatment groups after stratifying by clusters and correcting for skewness (Gart and Nam, 1990). Percentage can be obtained by multiplying proportion by 100.', 'statisticalMethod': 'Gart and Nam: correction of skewness', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority margin for the proportion of seizure free participants set at 10%; non-inferiority declared if the lower bound of the 95% confidence interval (CI) of the difference in seizure-free proportion between pregabalin and lamotrigine was no more than 10% in favor of lamotrigine, but 0 was contained within the lower bound of the CI. Interpretation of superiority required lower bound of CI did not contain 0 in favor of pregabalin.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 5 up to Week 56', 'description': 'Responders = participants who achieved any 6 consecutive months (\\>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) (intent to treat population): randomized participants who took at least 1 dose of study medication. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data. Analysis excludes participants who did not enter maintenance phase of study.'}, {'type': 'SECONDARY', 'title': 'Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000', 'lowerLimit': '199', 'upperLimit': '295'}, {'value': '183', 'groupId': 'OG001', 'lowerLimit': '183', 'upperLimit': '209'}]}]}], 'analyses': [{'pValue': '0.0034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.90', 'pValueComment': 'Nominal value for 2-sided test calculated using Cox proportional hazards model, adjusted for geographic regions.', 'groupDescription': 'Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \\> 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 4 up to Week 56', 'description': 'Time in days, from first day of study medication to the first 6 months of seizure freedom after Day 28. Participants who did not achieve 6 months seizure freedom after Day 28 were censored from analysis.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data.'}, {'type': 'SECONDARY', 'title': 'Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.74', 'pValueComment': 'Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.', 'groupDescription': 'Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \\< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 56', 'description': 'Number of participants who exited the study due to adverse events during the double-blind treatment period. Time in days, from first day of study treatment to day of exit from the study due to an adverse event (ie, last day on study medication) during the double blind treatment period (including dose escalation phase) was inestimable. Observations with other reasons for exiting or participants who did not exit the study were right censored as of the last day on study medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to adverse events was inestimable as survival estimate at end of maintenance phase was below 0.500.'}, {'type': 'SECONDARY', 'title': 'Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2537', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.60', 'pValueComment': 'Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.', 'groupDescription': 'Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \\< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 56', 'description': 'Number of participants who exited the study for any reason during the double blind treatment phase. Time in days, from first day of study treatment to day of exit from the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit the study were right censored as of the last day on study medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of participants who had at least 1 dose of study treatment and seizure efficacy data Time to exit for any reason during the double-blind treatment phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500.'}, {'type': 'SECONDARY', 'title': 'Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.52', 'ciLowerLimit': '1.93', 'ciUpperLimit': '22.04', 'pValueComment': 'Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.', 'groupDescription': 'Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \\< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 up to Week 56', 'description': 'Number of participants who exited the study due to lack of efficacy after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit due to lack of efficacy after Day 28 of the escalation phase (ie, last day on study medication) was inestimable. Participants who did not exit or exited for a different reason were right censored as of the last day on study medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit due to lack of efficacy after 4-week dose escalation phase was inestimable as survival estimate at end of maintenance phase was below 0.500.'}, {'type': 'SECONDARY', 'title': 'Exit Due to Any Reason After 4-week Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0744', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.91', 'pValueComment': 'Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.', 'groupDescription': 'Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \\< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 up to Week 56', 'description': 'Number of participants who exited the study due to any reason after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit after Day 28 of the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit or did not reach this phase were right censored as of the last day on study medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data. Time to exit for any reason after the 4-week dose escalation phase was inestimable as the survival estimate at the end of the maintenance phase was below 0.500.'}, {'type': 'SECONDARY', 'title': 'Time to First Seizure After the 4-Week Dose Escalation Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '120'}, {'value': '211', 'groupId': 'OG001', 'lowerLimit': '145', 'upperLimit': '342'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '1.19', 'ciUpperLimit': '1.80', 'pValueComment': 'Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.', 'groupDescription': 'Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \\< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 4 up to Week 56', 'description': 'Time in days, from first day of study treatment to the day of first seizure after Day 28 of the escalation phase (ie, last day on study medication). Participants who did not reach this phase or who did not have a seizure after Day 28 were right censored from the analysis as of the last day on study medication.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of participants who entered maintenance phase of study and had seizure efficacy data.'}, {'type': 'SECONDARY', 'title': 'Median Monthy Seizure Frequency: All Partial Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'title': 'Dose-escalation phase (Weeks 1 - 4) (n=329, 330)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '9.348', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '27.118', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 (n=314, 308)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '6.139', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '31.453', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 (n=300, 295)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.382', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '28.839', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (n=287, 288)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.568', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '32.783', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (n=279, 278)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.313', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '16.046', 'groupId': 'OG001'}]}]}, {'title': 'Month 5 (n=274, 276)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.270', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '15.254', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=266, 272)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.702', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '15.126', 'groupId': 'OG001'}]}]}, {'title': 'Month 7 (n=260, 270)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.839', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '16.855', 'groupId': 'OG001'}]}]}, {'title': 'Month 8 (n=256, 266)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.247', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '19.111', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (n=253, 262)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.538', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '17.204', 'groupId': 'OG001'}]}]}, {'title': 'Month 10 (n=250, 257)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '4.935', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '16.905', 'groupId': 'OG001'}]}]}, {'title': 'Month 11 (n=242, 254)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.082', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '19.268', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=238, 252)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '7.018', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '19.590', 'groupId': 'OG001'}]}]}, {'title': 'Month 13 (n=210, 227)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.247', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '19.462', 'groupId': 'OG001'}]}]}, {'title': 'Taper (Week 57 to Week 60) (n=71, 45)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '6.418', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '97.196', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Week 60', 'description': 'All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Month of time = number of months after Week 4 (Dose Escalation).', 'unitOfMeasure': 'seizures/28 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.'}, {'type': 'SECONDARY', 'title': 'Mean Monthy Seizure Frequency: All Partial Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'title': 'Dose escalation phase (n=329, 330)', 'categories': [{'measurements': [{'value': '2.56', 'spread': '9.348', 'groupId': 'OG000'}, {'value': '5.08', 'spread': '27.118', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 (n=314, 308)', 'categories': [{'measurements': [{'value': '2.23', 'spread': '6.139', 'groupId': 'OG000'}, {'value': '4.21', 'spread': '31.453', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 (n=300, 295)', 'categories': [{'measurements': [{'value': '1.18', 'spread': '3.382', 'groupId': 'OG000'}, {'value': '3.21', 'spread': '28.839', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (n=287, 288)', 'categories': [{'measurements': [{'value': '0.94', 'spread': '2.568', 'groupId': 'OG000'}, {'value': '3.54', 'spread': '32.783', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (n=279, 278)', 'categories': [{'measurements': [{'value': '0.89', 'spread': '2.313', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '16.046', 'groupId': 'OG001'}]}]}, {'title': 'Month 5 (n=274, 276)', 'categories': [{'measurements': [{'value': '0.78', 'spread': '2.270', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '15.254', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=266, 272)', 'categories': [{'measurements': [{'value': '0.82', 'spread': '2.702', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '15.126', 'groupId': 'OG001'}]}]}, {'title': 'Month 7 (n=260, 270)', 'categories': [{'measurements': [{'value': '0.78', 'spread': '2.839', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '16.855', 'groupId': 'OG001'}]}]}, {'title': 'Month 8 (n=256, 266)', 'categories': [{'measurements': [{'value': '0.77', 'spread': '3.247', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '19.111', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (n=253, 262)', 'categories': [{'measurements': [{'value': '0.71', 'spread': '2.538', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '17.204', 'groupId': 'OG001'}]}]}, {'title': 'Month 10 (n=250, 257)', 'categories': [{'measurements': [{'value': '1.05', 'spread': '4.935', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '16.905', 'groupId': 'OG001'}]}]}, {'title': 'Month 11 (n=242, 254)', 'categories': [{'measurements': [{'value': '0.79', 'spread': '3.082', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '19.268', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=238, 252)', 'categories': [{'measurements': [{'value': '0.94', 'spread': '7.018', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '19.590', 'groupId': 'OG001'}]}]}, {'title': 'Month 13 (n=210, 227)', 'categories': [{'measurements': [{'value': '0.65', 'spread': '3.247', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '19.462', 'groupId': 'OG001'}]}]}, {'title': 'Taper (n=71, 45)', 'categories': [{'measurements': [{'value': '2.13', 'spread': '6.418', 'groupId': 'OG000'}, {'value': '19.97', 'spread': '97.196', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 60', 'description': 'All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Month of time = number of months after Week 4 (Dose Escalation).', 'unitOfMeasure': 'seizures/28 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.'}, {'type': 'SECONDARY', 'title': 'Median Monthy Seizure Frequency: All Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'title': 'Dose-escalation phase (Weeks 1 - 4)(n=329, 330)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '9.819', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '27.128', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 (n=314, 308)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '6.164', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '31.452', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 (n=300, 295)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '5.498', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '28.838', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (n=287, 288)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.702', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '32.782', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (n=279, 278)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.223', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '16.046', 'groupId': 'OG001'}]}]}, {'title': 'Month 5 (n=274, 276)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.458', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '15.254', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=266, 272)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.853', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '15.126', 'groupId': 'OG001'}]}]}, {'title': 'Month 7 (n=260, 270)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.898', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '16.855', 'groupId': 'OG001'}]}]}, {'title': 'Month 8 (n=256, 266)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.304', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '19.110', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (n=253, 262)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.636', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '17.204', 'groupId': 'OG001'}]}]}, {'title': 'Month 10 (n=250, 257)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '4.934', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '16.905', 'groupId': 'OG001'}]}]}, {'title': 'Month 11 (n=242, 254)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.224', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '19.268', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=238, 252)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '7.019', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '19.590', 'groupId': 'OG001'}]}]}, {'title': 'Month 13 (n=210, 227)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.247', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '19.462', 'groupId': 'OG001'}]}]}, {'title': 'Taper (Week 57 to Week 60) (n=71, 45)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '6.418', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '97.196', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Week 60', 'description': 'Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Month of time = number of months after Week 4 (Dose Escalation).', 'unitOfMeasure': 'seizures/28 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.'}, {'type': 'SECONDARY', 'title': 'Mean Monthy Seizure Frequency: All Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'title': 'Dose-escalation phase (n=329, 330)', 'categories': [{'measurements': [{'value': '2.74', 'spread': '9.819', 'groupId': 'OG000'}, {'value': '5.10', 'spread': '27.128', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 (n=314, 308)', 'categories': [{'measurements': [{'value': '2.31', 'spread': '6.164', 'groupId': 'OG000'}, {'value': '4.24', 'spread': '31.452', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 (n=300, 295)', 'categories': [{'measurements': [{'value': '1.53', 'spread': '5.498', 'groupId': 'OG000'}, {'value': '3.22', 'spread': '28.838', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (n=287, 288)', 'categories': [{'measurements': [{'value': '1.02', 'spread': '2.702', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '32.782', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (n=279, 278)', 'categories': [{'measurements': [{'value': '1.06', 'spread': '3.223', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '16.046', 'groupId': 'OG001'}]}]}, {'title': 'Month 5 (n=274, 276)', 'categories': [{'measurements': [{'value': '0.87', 'spread': '2.458', 'groupId': 'OG000'}, {'value': '1.59', 'spread': '15.254', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=266, 272)', 'categories': [{'measurements': [{'value': '0.89', 'spread': '2.853', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '15.126', 'groupId': 'OG001'}]}]}, {'title': 'Month 7 (n=260, 270)', 'categories': [{'measurements': [{'value': '0.83', 'spread': '2.898', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '16.855', 'groupId': 'OG001'}]}]}, {'title': 'Month 8 (n=256, 266)', 'categories': [{'measurements': [{'value': '0.82', 'spread': '3.304', 'groupId': 'OG000'}, {'value': '1.37', 'spread': '19.110', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (n=253, 262)', 'categories': [{'measurements': [{'value': '0.78', 'spread': '2.636', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '17.204', 'groupId': 'OG001'}]}]}, {'title': 'Month 10 (n=250, 257)', 'categories': [{'measurements': [{'value': '1.06', 'spread': '4.934', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '16.905', 'groupId': 'OG001'}]}]}, {'title': 'Month 11 (n=242, 254)', 'categories': [{'measurements': [{'value': '0.81', 'spread': '3.224', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '19.268', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=238, 252)', 'categories': [{'measurements': [{'value': '0.96', 'spread': '7.019', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '19.590', 'groupId': 'OG001'}]}]}, {'title': 'Month 13 (n=210, 227)', 'categories': [{'measurements': [{'value': '0.65', 'spread': '3.247', 'groupId': 'OG000'}, {'value': '2.12', 'spread': '19.462', 'groupId': 'OG001'}]}]}, {'title': 'Taper (n=71, 45)', 'categories': [{'measurements': [{'value': '2.13', 'spread': '6.418', 'groupId': 'OG000'}, {'value': '19.97', 'spread': '97.196', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 60', 'description': 'Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Month of time = number of months after Week 4 (Dose Escalation).', 'unitOfMeasure': 'seizures/28 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of participants with analyzable data; n = number of participants with analyzable data at observation.'}, {'type': 'SECONDARY', 'title': 'Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'title': 'Month 1 (n=162, 208)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.000', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.226', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 (n=155, 194)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.783', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.226', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (n=147, 184)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.384', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.439', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (n=139, 173)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.329', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.211', 'groupId': 'OG001'}]}]}, {'title': 'Month 5 (n=127, 158)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.926', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.823', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=122, 152)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.156', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.213', 'groupId': 'OG001'}]}]}, {'title': 'Month 7 (n=105, 136)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.843', 'groupId': 'OG001'}]}]}, {'title': 'Month 8 (n=1, 5)', 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'n = 1.', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.000', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (n=0, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No responders with analyzable data at Month 9.', 'groupId': 'OG000'}, {'value': '6.0', 'spread': 'NA', 'comment': 'n = 1.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Month 1 through Month 9 (after 6 months seizure freedom achieved)', 'description': 'All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.', 'unitOfMeasure': 'seizures/28 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of responders; n = number of responders with analyzable data at observation.'}, {'type': 'SECONDARY', 'title': 'Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'title': 'Month 1 (n=162, 208)', 'categories': [{'measurements': [{'value': '0.19', 'spread': '1.000', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.226', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 (n=155, 194)', 'categories': [{'measurements': [{'value': '0.28', 'spread': '1.783', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.226', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (n=147, 184)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.384', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.439', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (n=139, 173)', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.329', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.211', 'groupId': 'OG001'}]}]}, {'title': 'Month 5 (n=127, 158)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.926', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.823', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=122, 152)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.156', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.213', 'groupId': 'OG001'}]}]}, {'title': 'Month 7 (n=105, 136)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '2.843', 'groupId': 'OG001'}]}]}, {'title': 'Month 8 (n=1, 5)', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Measure of dispersion cannot be calculated with a sample size of 1.', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (n=0, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No responders with analyzable data at Month 9.', 'groupId': 'OG000'}, {'value': '6.00', 'spread': 'NA', 'comment': 'Measure of dispersion cannot be calculated with a sample size of 1.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1 through Month 9 (after 6 months seizure freedom achieved)', 'description': 'All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.', 'unitOfMeasure': '28-day seizure rate', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of responders; n = number of responders with analyzable data at observation.'}, {'type': 'SECONDARY', 'title': 'Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'title': 'Month 1 (n=162, 208)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.000', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.236', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 (n=155, 194)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.783', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.226', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (n=147, 184)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.400', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.439', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (n=139, 173)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.359', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.211', 'groupId': 'OG001'}]}]}, {'title': 'Month 5 (n=127, 158)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.971', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.823', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=122, 152)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.156', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.213', 'groupId': 'OG001'}]}]}, {'title': 'Month 7 (n=105, 136)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.844', 'groupId': 'OG001'}]}]}, {'title': 'Month 8 (n=1, 5)', 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'n=1.', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.000', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (n=0, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No responders with analyzable data at Month 9.', 'groupId': 'OG000'}, {'value': '6.0', 'spread': 'NA', 'comment': 'n=1.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Month 1 through Month 9 (after 6 months seizure freedom achieved)', 'description': 'Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.', 'unitOfMeasure': 'seizures/28 days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of responders; n = number of responders with analyzable data at observation.'}, {'type': 'SECONDARY', 'title': 'Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'title': 'Month 1 (n=162, 208)', 'categories': [{'measurements': [{'value': '0.19', 'spread': '1.000', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.236', 'groupId': 'OG001'}]}]}, {'title': 'Month 2 (n=155, 194)', 'categories': [{'measurements': [{'value': '0.28', 'spread': '1.783', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.226', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 (n=147, 184)', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.400', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.439', 'groupId': 'OG001'}]}]}, {'title': 'Month 4 (n=139, 173)', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.359', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.211', 'groupId': 'OG001'}]}]}, {'title': 'Month 5 (n=127, 158)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.971', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.823', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=122, 152)', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.156', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.213', 'groupId': 'OG001'}]}]}, {'title': 'Month 7 (n=105, 136)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '2.844', 'groupId': 'OG001'}]}]}, {'title': 'Month 8 (n=1, 5)', 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Measure of dispersion cannot be calculated with a sample size of 1.', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.000', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (n=0, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No responders with analyzable data at Month 9.', 'groupId': 'OG000'}, {'value': '6.00', 'spread': 'NA', 'comment': 'Measure of dispersion cannot be calculated with a sample size of 1.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1 through Month 9 (after 6 months seizure freedom achieved)', 'description': 'Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.', 'unitOfMeasure': '28-day seizure rate', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N = number of responders; n = number of responders with analyzable data at observation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '164', 'groupId': 'OG004'}, {'value': '84', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin 150 mg/Day', 'description': 'Pregabalin 150 mg/day administered twice daily (BID)'}, {'id': 'OG001', 'title': 'Pregabalin 300 mg/Day', 'description': 'Pregabalin 300 mg/day administered BID'}, {'id': 'OG002', 'title': 'Pregabalin 450 mg/Day', 'description': 'Pregabalin 450 mg/day administered BID'}, {'id': 'OG003', 'title': 'Pregabalin 600 mg/Day', 'description': 'Pregabalin 600 mg/day administered BID'}, {'id': 'OG004', 'title': 'Lamotrigine 100 mg/Day', 'description': 'Lamotrigine 100 mg/day administered BID'}, {'id': 'OG005', 'title': 'Lamotrigine 200 mg/Day', 'description': 'Lamotrigine 200 mg/day administered BID'}, {'id': 'OG006', 'title': 'Lamotrigine 400 mg/Day', 'description': 'Lamotrigine 400 mg/day administered BID'}, {'id': 'OG007', 'title': 'Lamotrigine 500 mg/Day', 'description': 'Lamotrigine 500 mg/day administered BID'}], 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'groupId': 'OG000'}, {'value': '59.7', 'groupId': 'OG001'}, {'value': '20.4', 'groupId': 'OG002'}, {'value': '13.0', 'groupId': 'OG003'}, {'value': '80.5', 'groupId': 'OG004'}, {'value': '67.9', 'groupId': 'OG005'}, {'value': '38.2', 'groupId': 'OG006'}, {'value': '16.7', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 5 up to Week 56', 'description': 'Responder = participant who achieved at least 6-months of seizure freedom (all seizures) after Week 4, and up to Week 56. Dose Level defined as last total-daily-dose received after Week 4, and up to Week 56.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N = number of participants with analyzable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'title': 'Anxiety', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Depression', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.3', 'ciUpperLimit': '1.4', 'groupDescription': 'Anxiety; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0186', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.1', 'ciUpperLimit': '1.1', 'groupDescription': 'Depression; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 56', 'description': 'Participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items; range: 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of symptoms. Scores relative to start of randomized treatment.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; N = number of participants with a HADS measurement at baseline and Week 56.'}, {'type': 'SECONDARY', 'title': 'Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'OG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}], 'classes': [{'title': 'Week 8: Optimal sleep', 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: Non-optimal sleep', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}]}, {'title': 'Week 32: Optimal sleep', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}]}, {'title': 'Week 32: Non-optimal sleep', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Week 56: Optimal sleep', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}, {'title': 'Week 56: Non-optimal sleep', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0683', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.93', 'groupDescription': 'Week 8: dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. 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Analysis assesses the MOS-Sleep scale relative to the start of randomized treatment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregabalin', 'description': 'Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'FG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. 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Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'BG001', 'title': 'Lamotrigine', 'description': 'Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 18 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Between 18 and 44 years', 'categories': [{'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '456', 'groupId': 'BG002'}]}]}, {'title': 'Between 45 and 64 years', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 660}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2006-01-18', 'resultsFirstSubmitDate': '2010-12-16', 'studyFirstSubmitQcDate': '2006-01-18', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-10-20', 'studyFirstPostDateStruct': {'date': '2006-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase', 'timeFrame': 'Week 5 up to Week 56', 'description': 'Responders = participants who achieved any 6 consecutive months (\\>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase.'}], 'secondaryOutcomes': [{'measure': 'Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures', 'timeFrame': 'Week 4 up to Week 56', 'description': 'Time in days, from first day of study medication to the first 6 months of seizure freedom after Day 28. Participants who did not achieve 6 months seizure freedom after Day 28 were censored from analysis.'}, {'measure': 'Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)', 'timeFrame': 'Week 0 to Week 56', 'description': 'Number of participants who exited the study due to adverse events during the double-blind treatment period. Time in days, from first day of study treatment to day of exit from the study due to an adverse event (ie, last day on study medication) during the double blind treatment period (including dose escalation phase) was inestimable. Observations with other reasons for exiting or participants who did not exit the study were right censored as of the last day on study medication.'}, {'measure': 'Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)', 'timeFrame': 'Week 0 to Week 56', 'description': 'Number of participants who exited the study for any reason during the double blind treatment phase. Time in days, from first day of study treatment to day of exit from the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit the study were right censored as of the last day on study medication.'}, {'measure': 'Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase', 'timeFrame': 'Week 4 up to Week 56', 'description': 'Number of participants who exited the study due to lack of efficacy after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit due to lack of efficacy after Day 28 of the escalation phase (ie, last day on study medication) was inestimable. Participants who did not exit or exited for a different reason were right censored as of the last day on study medication.'}, {'measure': 'Exit Due to Any Reason After 4-week Dose Escalation Phase', 'timeFrame': 'Week 4 up to Week 56', 'description': 'Number of participants who exited the study due to any reason after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit after Day 28 of the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit or did not reach this phase were right censored as of the last day on study medication.'}, {'measure': 'Time to First Seizure After the 4-Week Dose Escalation Phase', 'timeFrame': 'Week 4 up to Week 56', 'description': 'Time in days, from first day of study treatment to the day of first seizure after Day 28 of the escalation phase (ie, last day on study medication). Participants who did not reach this phase or who did not have a seizure after Day 28 were right censored from the analysis as of the last day on study medication.'}, {'measure': 'Median Monthy Seizure Frequency: All Partial Seizures', 'timeFrame': 'Baseline up to Week 60', 'description': 'All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Month of time = number of months after Week 4 (Dose Escalation).'}, {'measure': 'Mean Monthy Seizure Frequency: All Partial Seizures', 'timeFrame': 'Baseline up to Week 60', 'description': 'All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Month of time = number of months after Week 4 (Dose Escalation).'}, {'measure': 'Median Monthy Seizure Frequency: All Seizures', 'timeFrame': 'Baseline up to Week 60', 'description': 'Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Month of time = number of months after Week 4 (Dose Escalation).'}, {'measure': 'Mean Monthy Seizure Frequency: All Seizures', 'timeFrame': 'Baseline up to Week 60', 'description': 'Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Month of time = number of months after Week 4 (Dose Escalation).'}, {'measure': 'Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures', 'timeFrame': 'Month 1 through Month 9 (after 6 months seizure freedom achieved)', 'description': 'All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.'}, {'measure': 'Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures', 'timeFrame': 'Month 1 through Month 9 (after 6 months seizure freedom achieved)', 'description': 'All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.'}, {'measure': 'Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures', 'timeFrame': 'Month 1 through Month 9 (after 6 months seizure freedom achieved)', 'description': 'Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.'}, {'measure': 'Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures', 'timeFrame': 'Month 1 through Month 9 (after 6 months seizure freedom achieved)', 'description': 'Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period \\* 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.'}, {'measure': 'Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group', 'timeFrame': 'Week 5 up to Week 56', 'description': 'Responder = participant who achieved at least 6-months of seizure freedom (all seizures) after Week 4, and up to Week 56. Dose Level defined as last total-daily-dose received after Week 4, and up to Week 56.'}, {'measure': 'Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline to Week 56', 'description': 'Participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items; range: 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of symptoms. Scores relative to start of randomized treatment.'}, {'measure': 'Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale', 'timeFrame': 'Week 8, Week 32, and Week 56', 'description': 'MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response Optimal if sleep quantity was 7 or 8 hours of sleep per night, and Non-optimal if average sleep was less than or greater than 7 to 8 hours per night. Analysis assesses the MOS-Sleep scale relative to the start of randomized treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'partial seizures', 'pregabalin monotherapy', 'lamotrigine comparator', 'double-blind and randomized trial'], 'conditions': ['Epilepsy, Partial']}, 'referencesModule': {'references': [{'pmid': '21889410', 'type': 'DERIVED', 'citation': 'Kwan P, Brodie MJ, Kalviainen R, Yurkewicz L, Weaver J, Knapp LE. Efficacy and safety of pregabalin versus lamotrigine in patients with newly diagnosed partial seizures: a phase 3, double-blind, randomised, parallel-group trial. Lancet Neurol. 2011 Oct;10(10):881-90. doi: 10.1016/S1474-4422(11)70154-5. Epub 2011 Aug 31.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081046&StudyName=Study%20Of%20The%20Safety%20And%20Efficacy%20Of%20Lyrica%20In%20The%20Treatment%20Of%20Newly%20Diagnosed%20Partial%20Epilepsy', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be diagnosed with partial epilepsy and have experienced at least 2 partial seizures (simple partial, complex partial or partial seizure with secondary generalization) in the past year with one in the past 6 months.\n\nExclusion Criteria:\n\n* Treatable 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