Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-01 @ 10:49 PM
Study NCT ID:
NCT00566020
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2007-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Evaluation Of BW430C (Lamotrigine) In Bipolar I Disorder- Long-term Extension Of Study SCA104779 (NCT00550407) -
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077213', 'term': 'Lamotrigine'}], 'ancestors': [{'id': 'D014227', 'term': 'Triazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation', 'otherNumAtRisk': 92, 'otherNumAffected': 52, 'seriousNumAtRisk': 92, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Self injurious behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Any Serious Adverse Event (SAE) and Any Non Serious Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Participants with any SAE', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Participants with any non-serious AE', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Week 0) until 2 weeks after the end of treatment (Week 54)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, which does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants who received at least one dose of study medication'}, {'type': 'PRIMARY', 'title': 'Number of Participants With the Indicated Clinical Laboratory Test Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'ALP, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ALP, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALP, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ALP, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALP, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ALP, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'ALP, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ALT, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALT, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALT, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALT, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALT, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ALT, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'ALT, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AST, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'AST, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'AST, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AST, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'AST, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'AST, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AST, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'AST, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'AST, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AST, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'AST, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'AST, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AST, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'AST, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'AST, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AST, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'AST, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'AST, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GGT, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GGT, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GGT, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GGT, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GGT, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'GGT, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'GGT, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'LDH, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'LDH, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'LDH, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'LDH, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'LDH, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'LDH, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'LDH, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/Early Withdrawal (EW)', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: ALP, ALT, AST, GGT, and LDH. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: ALP, 104-338 International Units per liter (IU/L); ALT, 5-45 IU/L; AST, 10-40 IU/L; GGT, Male: 0-79 IU/L, Female: 0-48 IU/L; LDH 120-245 IU/L.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Bilirubin and Creatinine at Weeks 0, 6, 16, 28, 40, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Total bilirubin, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: total bilirubin and creatinine. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: total bilirubin, 3.42-17.1 micromoles per liter (UMOL/L); creatinine, Male: 57.46-96.356 UMOL/L, Female: 40.664-72.488 UMOL/L.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Calcium, Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at Weeks 0, 6, 16, 28, 40, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Calcium, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Cholesterol, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Normal Week 0; n=92', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Urea/BUN, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'Participants were evaluated for the following clinical laboratory parameters for blood chemistry at the indicated time points: electrolytes (calcium, chloride, potassium, sodium), cholesterol, triglycerides, and urea/BUN. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges (micromoles per liter \\[MMOL/L\\]): calcium, 2.0459-2.495; chloride, 98-108; potassium, 3.5-5; sodium, 135-145; cholesterol, 3.879-5.66334; triglycerides, 0.565-1.6837; urea/BUN, 2.856-7.14.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Platelet Count and White Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Platelet count, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, High, Week 40; n=68', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, Normal, Week 40; n=68', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, Low, Week 40; n=68', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, High, Week 40; n=69', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, Normal, Week 40; n=69', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, Low, Week 40; n=69', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell count, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters of hematology at the indicated time points: platelet count and white blood cell count. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: platelet count, 140-379 GI (gibi; 10\\^9) per liter (GI/L); white blood cell count, 3.5-9.7 GI/L.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Protein, Hemoglobin, and Hematocrit at Weeks 0, 6, 16, 28, 40, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Total protein, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, High, Week 40; n=70', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, Normal, Week 40; n=70', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, Low, Week 40; n=70', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'Total protein, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, High, Week 40; n=69', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Normal, Week 40; n=69', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Low, Week 40; n=69', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, High, Week 40; n=69', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Normal, Week 40; n=69', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Low, Week 40; n=69', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'Participants in the study were evaluated for total protein, hemoglobin, and hematocrit at the indicated time points. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: total protein, 65-82 grams per liter (G/L); hemoglobin, Male: 136-183 G/L, Female: 112-152 G/L; hematocrit (proportion of 1), Male: 0.404-0.519, Female: 0.343-0.452.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Red Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Red blood cell count, High, Week 0; n=92', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, Normal, Week 0; n=92', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, Low, Week 0; n=92', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, High, Week 6; n=84', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, Normal, Week 6; n=84', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, Low, Week 6; n=84', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, High, Week 16; n=78', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, Normal, Week 16; n=78', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, Low, Week 16; n=78', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, High, Week 28; n=77', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, Normal, Week 28; n=77', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, Low, Week 28; n=77', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, High, Week 40; n=69', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, Normal, Week 40; n=69', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, Low, Week 40; n=69', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, High, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, Normal, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'Red blood cell count, Low, Week 52/EW; n=86', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'Red blood cell count was measured in participants at the indicated time points. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: red blood cell count, Male: 4.38-5.77 TI (tebi; 10\\^12)/L, Female: 3.76-5.16 TI/L.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'PRIMARY', 'title': 'Number of Participants in the Indicated Category for Urine Glucose, Urine Protein, and Urine Urobilinogen at Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Urine Glucose, Week 0, NEG [-]; n=92', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 0, TRA [+/-]; n=92', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 0, 1+; n=92', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 0, 2+; n=92', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 0, 3+; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 0, 4+; n=92', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 0, 5+; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 6, NEG [-]; n=84', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 6, TRA [+/-]; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 6, 1+; n=84', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 6, 2+; n=84', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 6, 3+; n=84', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 6, 4+; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 6, 5+; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 16, NEG [-]; n=78', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 16, TRA [+/-]; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 16, 1+; n=78', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 16, 2+; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 16, 3+; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 16, 4+; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 16, 5+; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 28, NEG [-]; n=77', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 28, TRA [+/-]; n=77', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 28, 1+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 28, 2+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 28, 3+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 28, 4+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 28, 5+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 40, NEG [-]; n=70', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 40, TRA [+/-]; n=70', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 40, 1+; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 40, 2+; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 40, 3+; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 40, 4+; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 40, 5+; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 52/EW, NEG [-]; n=86', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 52/EW, TRA [+/-]; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 52/EW, 1+; n=86', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 52/EW, 2+; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 52/EW, 3+; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 52/EW, 4+; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Glucose, Week 52/EW, 5+; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 0, NEG [-]; n=92', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 0, TRA [+/-]; n=92', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 0, 1+; n=92', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 0, 2+; n=92', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 0, 3+; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 0, 4+; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 0, 5+; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 6, NEG [-]; n=84', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 6, TRA [+/-]; n=84', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 6, 1+; n=84', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 6, 2+; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 6, 3+; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 6, 4+; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 6, 5+; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 16, NEG [-]; n=78', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 16, TRA [+/-]; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 16, 1+; n=78', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 16, 2+; n=78', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 16, 3+; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 16, 4+; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 16, 5+; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 28, NEG [-]; n=77', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 28, TRA [+/-]; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 28, 1+; n=77', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 28, 2+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 28, 3+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 28, 4+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 28, 5+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 40, NEG [-]; n=70', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 40, TRA [+/-]; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 40, 1+; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 40, 2+; n=70', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 40, 3+; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 40, 4+; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 40, 5+; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 52/EW, NEG [-]; n=86', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 52/EW, TRA [+/-]; n=86', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 52/EW, 1+; n=86', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 52/EW, 2+; n=86', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 52/EW, 3+; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 52/EW, 4+; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Protein, Week 52/EW, 5+; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 0, NEG [-]; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 0, TRA [+/-]; n=92', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 0, 1+; n=92', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 0, 2+; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 0, 3+; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 0, 4+; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 0, 5+; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 6, NEG [-]; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 6, TRA [+/-]; n=84', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 6, 1+; n=84', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 6, 2+; n=84', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 6, 3+; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 6, 4+; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 6, 5+; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 16, NEG [-]; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 16, TRA [+/-]; n=78', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 16, 1+; n=78', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 16, 2+; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 16, 3+; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 16, 4+; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 16, 5+; n=78', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 28, NEG [-]; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 28, TRA [+/-]; n=77', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 28, 1+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 28, 2+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 28, 3+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 28, 4+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 28, 5+; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 40, NEG [-]; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 40, TRA [+/-]; n=70', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 40, 1+; n=70', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 40, 2+; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 40, 3+; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 40, 4+; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 40, 5+; n=70', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 52/EW, NEG [-]; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 52/EW, TRA [+/-]; n=86', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 52/EW, 1+; n=86', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 52/EW, 2+; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 52/EW, 3+; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 52/EW, 4+; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Urine Urobilinogen, Week 52/EW, 5+; n=86', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'Urine glucose, urine protein, and urine urobilinogen were measured in participants at the indicated time points. In this dipstick (qualitative) test, the level of glucose, protein, and urobilinogen in urine samples was recorded as negative (NEG \\[-\\]), trace (TRA \\[+/-\\]), 1+, 2+, 3+, 4+, and 5+ (the plus sign increases with a higher level of glucose, protein, or urobilinogen in the urine: 1+=slightly positive, 2+=positive, 3+=high positive, 4+=very high positive, 5+=more positive than 4+).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'PRIMARY', 'title': 'Mean Systolic Blood Pressure and Diastolic Blood Pressure of Participants at Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Systolic blood pressure, Week 0; n=92', 'categories': [{'measurements': [{'value': '119.9', 'spread': '15.40', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 2; n=87', 'categories': [{'measurements': [{'value': '121.7', 'spread': '16.11', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 4; n=85', 'categories': [{'measurements': [{'value': '118.9', 'spread': '15.77', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 5; n=85', 'categories': [{'measurements': [{'value': '119.0', 'spread': '16.26', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 6; n=84', 'categories': [{'measurements': [{'value': '120.4', 'spread': '16.09', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 8; n=81', 'categories': [{'measurements': [{'value': '118.6', 'spread': '16.28', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 12; n=79', 'categories': [{'measurements': [{'value': '120.1', 'spread': '15.71', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 16; n=78', 'categories': [{'measurements': [{'value': '119.1', 'spread': '16.76', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 20; n=77', 'categories': [{'measurements': [{'value': '117.8', 'spread': '15.04', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 24; n=77', 'categories': [{'measurements': [{'value': '118.5', 'spread': '15.30', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 28; n=77', 'categories': [{'measurements': [{'value': '117.3', 'spread': '18.84', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 32; n=76', 'categories': [{'measurements': [{'value': '121.8', 'spread': '17.04', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 36; n=73', 'categories': [{'measurements': [{'value': '121.3', 'spread': '15.80', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 40; n=70', 'categories': [{'measurements': [{'value': '118.2', 'spread': '15.21', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 44; n=69', 'categories': [{'measurements': [{'value': '118.7', 'spread': '14.88', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 48; n=69', 'categories': [{'measurements': [{'value': '121.2', 'spread': '16.37', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure, Week 52/EW; n=87', 'categories': [{'measurements': [{'value': '118.2', 'spread': '14.20', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 0; n=92', 'categories': [{'measurements': [{'value': '74.2', 'spread': '11.41', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 2; n=87', 'categories': [{'measurements': [{'value': '74.9', 'spread': '11.62', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 4; n=85', 'categories': [{'measurements': [{'value': '74.2', 'spread': '12.08', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 5; n=85', 'categories': [{'measurements': [{'value': '73.8', 'spread': '12.34', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 6; n=84', 'categories': [{'measurements': [{'value': '73.7', 'spread': '11.16', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 8; n=81', 'categories': [{'measurements': [{'value': '72.6', 'spread': '12.72', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 12; n=79', 'categories': [{'measurements': [{'value': '73.2', 'spread': '12.08', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 16; n=78', 'categories': [{'measurements': [{'value': '73.0', 'spread': '12.29', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 20; n=77', 'categories': [{'measurements': [{'value': '73.6', 'spread': '11.59', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 24; n=77', 'categories': [{'measurements': [{'value': '74.2', 'spread': '11.72', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 28; n=77', 'categories': [{'measurements': [{'value': '71.1', 'spread': '12.24', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 32; n=76', 'categories': [{'measurements': [{'value': '74.0', 'spread': '11.93', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 36; n=73', 'categories': [{'measurements': [{'value': '72.4', 'spread': '10.98', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 40; n=70', 'categories': [{'measurements': [{'value': '72.3', 'spread': '12.04', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 44; n=69', 'categories': [{'measurements': [{'value': '73.0', 'spread': '12.22', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 48; n=69', 'categories': [{'measurements': [{'value': '72.7', 'spread': '11.91', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure, Week 52/EW; n=87', 'categories': [{'measurements': [{'value': '73.2', 'spread': '11.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'description': 'Systolic and diastolic blood pressure was measured in participants at the indicated time points.', 'unitOfMeasure': 'Millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'PRIMARY', 'title': 'Mean Heart Rate of Participants at Week 0 (Baseline) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Week 0; n=92', 'categories': [{'measurements': [{'value': '76.3', 'spread': '12.48', 'groupId': 'OG000'}]}]}, {'title': 'Week 2; n=87', 'categories': [{'measurements': [{'value': '78.0', 'spread': '12.77', 'groupId': 'OG000'}]}]}, {'title': 'Week 4; n=85', 'categories': [{'measurements': [{'value': '77.4', 'spread': '11.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 5; n=85', 'categories': [{'measurements': [{'value': '78.5', 'spread': '12.54', 'groupId': 'OG000'}]}]}, {'title': 'Week 6; n=84', 'categories': [{'measurements': [{'value': '77.0', 'spread': '11.97', 'groupId': 'OG000'}]}]}, {'title': 'Week 8; n=81', 'categories': [{'measurements': [{'value': '76.8', 'spread': '11.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 12; n=79', 'categories': [{'measurements': [{'value': '79.0', 'spread': '13.47', 'groupId': 'OG000'}]}]}, {'title': 'Week 16; n=78', 'categories': [{'measurements': [{'value': '76.5', 'spread': '11.81', 'groupId': 'OG000'}]}]}, {'title': 'Week 20; n=77', 'categories': [{'measurements': [{'value': '77.4', 'spread': '11.09', 'groupId': 'OG000'}]}]}, {'title': 'Week 24; n=77', 'categories': [{'measurements': [{'value': '74.9', 'spread': '12.50', 'groupId': 'OG000'}]}]}, {'title': 'Week 28; n=77', 'categories': [{'measurements': [{'value': '75.9', 'spread': '10.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 32; n=76', 'categories': [{'measurements': [{'value': '77.2', 'spread': '12.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 36; n=73', 'categories': [{'measurements': [{'value': '76.8', 'spread': '11.46', 'groupId': 'OG000'}]}]}, {'title': 'Week 40; n=70', 'categories': [{'measurements': [{'value': '75.8', 'spread': '10.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 44; n=69', 'categories': [{'measurements': [{'value': '77.3', 'spread': '11.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 48; n=69', 'categories': [{'measurements': [{'value': '78.2', 'spread': '11.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW; n=87', 'categories': [{'measurements': [{'value': '74.8', 'spread': '11.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'description': 'Heart rate was measured in participants at the indicated time points.', 'unitOfMeasure': 'beat per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'PRIMARY', 'title': 'Mean Weight of Participants at Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Week 0; n=92', 'categories': [{'measurements': [{'value': '60.86', 'spread': '12.532', 'groupId': 'OG000'}]}]}, {'title': 'Week 6; n=84', 'categories': [{'measurements': [{'value': '61.62', 'spread': '12.405', 'groupId': 'OG000'}]}]}, {'title': 'Week 8; n=81', 'categories': [{'measurements': [{'value': '61.29', 'spread': '12.420', 'groupId': 'OG000'}]}]}, {'title': 'Week 12; n=79', 'categories': [{'measurements': [{'value': '61.26', 'spread': '12.685', 'groupId': 'OG000'}]}]}, {'title': 'Week 16; n=78', 'categories': [{'measurements': [{'value': '61.38', 'spread': '12.753', 'groupId': 'OG000'}]}]}, {'title': 'Week 20; n=77', 'categories': [{'measurements': [{'value': '61.19', 'spread': '12.929', 'groupId': 'OG000'}]}]}, {'title': 'Week 24; n=77', 'categories': [{'measurements': [{'value': '61.29', 'spread': '12.712', 'groupId': 'OG000'}]}]}, {'title': 'Week 28; n=77', 'categories': [{'measurements': [{'value': '60.99', 'spread': '12.688', 'groupId': 'OG000'}]}]}, {'title': 'Week 32; n=76', 'categories': [{'measurements': [{'value': '61.05', 'spread': '12.840', 'groupId': 'OG000'}]}]}, {'title': 'Week 36; n=73', 'categories': [{'measurements': [{'value': '61.06', 'spread': '13.097', 'groupId': 'OG000'}]}]}, {'title': 'Week 40; n=70', 'categories': [{'measurements': [{'value': '60.67', 'spread': '13.214', 'groupId': 'OG000'}]}]}, {'title': 'Week 44; n=69', 'categories': [{'measurements': [{'value': '60.72', 'spread': '13.214', 'groupId': 'OG000'}]}]}, {'title': 'Week 48; n=69', 'categories': [{'measurements': [{'value': '60.43', 'spread': '13.056', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW; n=87', 'categories': [{'measurements': [{'value': '60.09', 'spread': '12.765', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'description': 'The weight of participants was recorded at the indicated time points.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'PRIMARY', 'title': 'Mean Body Mass Index (BMI) of All Participants at Week 0 (Baseline) and Weeks 6, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Week 0; n=92', 'categories': [{'measurements': [{'value': '22.8', 'spread': '3.934', 'groupId': 'OG000'}]}]}, {'title': 'Week 6; n=84', 'categories': [{'measurements': [{'value': '23.01', 'spread': '3.878', 'groupId': 'OG000'}]}]}, {'title': 'Week 8; n=81', 'categories': [{'measurements': [{'value': '22.89', 'spread': '3.863', 'groupId': 'OG000'}]}]}, {'title': 'Week 12; n=79', 'categories': [{'measurements': [{'value': '22.93', 'spread': '3.975', 'groupId': 'OG000'}]}]}, {'title': 'Week 16; n=78', 'categories': [{'measurements': [{'value': '22.96', 'spread': '3.965', 'groupId': 'OG000'}]}]}, {'title': 'Week 20; n=77', 'categories': [{'measurements': [{'value': '22.86', 'spread': '3.941', 'groupId': 'OG000'}]}]}, {'title': 'Week 24; n=77', 'categories': [{'measurements': [{'value': '22.91', 'spread': '3.916', 'groupId': 'OG000'}]}]}, {'title': 'Week 28; n=77', 'categories': [{'measurements': [{'value': '22.80', 'spread': '3.970', 'groupId': 'OG000'}]}]}, {'title': 'Week 32; n=76', 'categories': [{'measurements': [{'value': '22.81', 'spread': '4.016', 'groupId': 'OG000'}]}]}, {'title': 'Week 36; n=73', 'categories': [{'measurements': [{'value': '22.71', 'spread': '4.041', 'groupId': 'OG000'}]}]}, {'title': 'Week 40; n=70', 'categories': [{'measurements': [{'value': '22.48', 'spread': '3.820', 'groupId': 'OG000'}]}]}, {'title': 'Week 44; n=69', 'categories': [{'measurements': [{'value': '22.51', 'spread': '3.785', 'groupId': 'OG000'}]}]}, {'title': 'Week 48; n=69', 'categories': [{'measurements': [{'value': '22.40', 'spread': '3.750', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW; n=87', 'categories': [{'measurements': [{'value': '22.42', 'spread': '3.818', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Weeks 0, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'description': 'The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.', 'unitOfMeasure': 'Kilograms per meters squared', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 0, 6, 28, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Week 0, Normal; n=92', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Week 0, Abnormal-NCS; n=92', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Week 0, Abnormal-CS; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 0, No result; n=92', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 6, Normal; n=84', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Week 6, Abnormal-NCS; n=84', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Week 6, Abnormal-CS; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 6, No result; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, Normal; n=77', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, Abnormal-NCS; n=77', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, Abnormal-CS; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, No result; n=77', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (EW), Normal; n=84', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (EW), Abnormal-NCS; n=84', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (EW), Abnormal-CS; n=84', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (EW), No result; n=84', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0, 6, 28, and 52/EW', 'description': 'ECGs were recorded in participants at the indicated time points. ECG findings, as determined by the physicians, were reported as normal, abnormal but not clinically significant (NCS), abnormal but clinically significant (CS), and no result. Specific definitions of ECG categorizations were not provided; physicians were expected to apply reasonable standards of clinical judgment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Week 0, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 0, OC; n=92', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 2, LOCF; n=91', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 2, OC; n=87', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 4, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 4, OC; n=85', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'Week 5, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 5, OC; n=85', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'Week 6, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 6, OC; n=84', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.89', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, OC; n=81', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, OC; n=79', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, OC; n=78', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.94', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, OC; n=77', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, OC; n=77', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, OC; n=77', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 32, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 32, OC; n=76', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 36, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 36, OC; n=73', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, OC; n=70', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'Week 44, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 44, OC; n=69', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, OC; n=69', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW, LOCF; n=92', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW, OC; n=87', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.25', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'description': "The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): participants who received \\>=1 dose of study medication and underwent \\>=1 efficacy assessment. Observed Cases (OC; observed data with no imputation) and Last Observation Carried Forward (LOCF; data imputed \\[replaced\\] by most recent observed value \\[compared to planned date of missing observation\\]) were used for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Week 2, LOCF; n=91', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 2, OC; n=87', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.92', 'groupId': 'OG000'}]}]}, {'title': 'Week 4, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 4, OC; n=85', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 5, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.07', 'groupId': 'OG000'}]}]}, {'title': 'Week 5, LOCF; n=85', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 6, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.07', 'groupId': 'OG000'}]}]}, {'title': 'Week 6, OC; n=84', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, LOCF; n=81', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, OC; n=79', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, OC; n=78', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, OC; n=77', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.09', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, OC; n=77', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, OC; n=77', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 32, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 32, OC; n=76', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 36, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 36, OC; n=73', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, OC; n=70', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 44, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 44, OC; n=69', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, OC; n=69', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW, LOCF; n=92', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW, OC; n=87', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'description': "The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. Change from baseline was calculated as the values at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (or EW) minus the baseline value (Week 0).", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'SECONDARY', 'title': 'Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Week 6, LOCF; n=91', 'categories': [{'measurements': [{'value': '5.2', 'spread': '6.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 6, OC; n=84', 'categories': [{'measurements': [{'value': '4.3', 'spread': '4.85', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, LOCF; n=91', 'categories': [{'measurements': [{'value': '6.1', 'spread': '7.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, OC; n=78', 'categories': [{'measurements': [{'value': '5.2', 'spread': '6.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, LOCF; n=91', 'categories': [{'measurements': [{'value': '5.5', 'spread': '6.76', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, OC; n=77', 'categories': [{'measurements': [{'value': '4.5', 'spread': '5.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, LOCF; n=91', 'categories': [{'measurements': [{'value': '5.9', 'spread': '7.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, OC; n=70', 'categories': [{'measurements': [{'value': '4.7', 'spread': '5.53', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW, LOCF; n=91', 'categories': [{'measurements': [{'value': '5.5', 'spread': '7.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW, OC; n=87', 'categories': [{'measurements': [{'value': '5.4', 'spread': '7.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 6, 16, 28, 40, and 52/EW', 'description': 'The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Week 6, LOCF; n=91', 'categories': [{'measurements': [{'value': '-4.5', 'spread': '7.37', 'groupId': 'OG000'}]}]}, {'title': 'Week 6, OC; n=84', 'categories': [{'measurements': [{'value': '-4.7', 'spread': '7.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, LOCF; n=91', 'categories': [{'measurements': [{'value': '-3.7', 'spread': '7.51', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, OC; n=78', 'categories': [{'measurements': [{'value': '-3.8', 'spread': '7.51', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, LOCF; n=91', 'categories': [{'measurements': [{'value': '-4.3', 'spread': '7.62', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, OC; n=77', 'categories': [{'measurements': [{'value': '-4.5', 'spread': '7.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, LOCF; n=91', 'categories': [{'measurements': [{'value': '-3.9', 'spread': '7.77', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, OC; n=70', 'categories': [{'measurements': [{'value': '-3.9', 'spread': '7.69', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW, LOCF; n=91', 'categories': [{'measurements': [{'value': '-4.3', 'spread': '7.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW, OC; n=87', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '6.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'SECONDARY', 'title': 'Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Week 6, LOCF; n=91', 'categories': [{'measurements': [{'value': '3.2', 'spread': '6.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 6, OC; n=84', 'categories': [{'measurements': [{'value': '2.6', 'spread': '4.37', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, LOCF; n=91', 'categories': [{'measurements': [{'value': '2.6', 'spread': '5.83', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, OC; n=78', 'categories': [{'measurements': [{'value': '1.7', 'spread': '3.02', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, LOCF; n=91', 'categories': [{'measurements': [{'value': '2.8', 'spread': '6.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, OC; n=77', 'categories': [{'measurements': [{'value': '2.0', 'spread': '5.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, LOCF; n=91', 'categories': [{'measurements': [{'value': '2.7', 'spread': '6.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, OC; n=70', 'categories': [{'measurements': [{'value': '1.7', 'spread': '3.95', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW, LOCF; n=91', 'categories': [{'measurements': [{'value': '1.9', 'spread': '5.55', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW, OC; n=87', 'categories': [{'measurements': [{'value': '2.0', 'spread': '5.66', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 6, 16, 28, 40, and 52/EW', 'description': 'The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. For all items, 0 is the "best" rating and 4 or 8 is the "worst" rating. YMRS total score was computed as the sum of the scores for the 11 items on the scale. The possible total scores range from 0 (best) to 60 (worst).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Week 6, LOCF; n=91', 'categories': [{'measurements': [{'value': '0.2', 'spread': '6.64', 'groupId': 'OG000'}]}]}, {'title': 'Week 6, OC; n=84', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '5.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, LOCF; n=91', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '7.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, OC; n=78', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '6.13', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, LOCF; n=91', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '6.89', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, OC; n=77', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '5.75', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, LOCF; n=91', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '7.56', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, OC; n=70', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '6.73', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW, LOCF; n=91', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '7.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 52/EW, OC; n=87', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '7.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. YMRS total score (range of 0-60) was computed as sum of the scores for the 11 items on the scale. Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. OC and LOCF datasets were used for analysis. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points).'}, {'type': 'SECONDARY', 'title': 'Median Serum Lamotrigine 200 mg Concentration Among Participants With Concomitant Use of Inducer and Without Inhibitor (at the Timing of Blood Sample Collection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'categories': [{'measurements': [{'value': '1605.70', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '3238.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from Week 6 to Week 52/EW', 'description': 'Pharmacokinetic (PK) samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Participants who took at least one dose of drugs that induce lamotrigine glucuronidation (e.g., carbamazepine) from the date of the first dose of study medication to the date of the last dose.'}, {'type': 'SECONDARY', 'title': 'Median Serum Lamotrigine 100 mg and 200 mg Concentration Among Participants With Concomitant Use of Inhibitor (at the Timing of Blood Sample Collection)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Lamotrigine 100 mg; n=5', 'categories': [{'measurements': [{'value': '5312.30', 'groupId': 'OG000', 'lowerLimit': '3762.7', 'upperLimit': '15107.0'}]}]}, {'title': 'Lamotrigine 200 mg; n=4', 'categories': [{'measurements': [{'value': '6935.40', 'groupId': 'OG000', 'lowerLimit': '3210.2', 'upperLimit': '9300.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from Week 6 to Week 52/EW', 'description': 'PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Participants (par.) who took at least one dose of drugs that inhibit lamotrigine glucuronidation (i.e., valproate) from the date of the first dose of study medication to the date of the last dose. A total of 8 par. were analyzed; 1 par. had both 100 and 200 mg data, 4 par. had 100 mg data only, and 3 par. had 200 mg data only.'}, {'type': 'SECONDARY', 'title': 'Median Serum Lamotrigine 25, 100, 125, 150, 200, 225, 300, and 400 mg Concentrations Among Participants Without Concomitant Use of Inhibitor and Inducer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'classes': [{'title': 'Lamotrigine 25 mg; n=2', 'categories': [{'measurements': [{'value': '699.95', 'groupId': 'OG000', 'lowerLimit': '527.8', 'upperLimit': '872.1'}]}]}, {'title': 'Lamotrigine 100 mg; n=12', 'categories': [{'measurements': [{'value': '2793.55', 'groupId': 'OG000', 'lowerLimit': '1486.7', 'upperLimit': '7440.8'}]}]}, {'title': 'Lamotrigine 125 mg; n=1', 'categories': [{'measurements': [{'value': '3505.30', 'groupId': 'OG000', 'lowerLimit': '3505.3', 'upperLimit': '3505.3'}]}]}, {'title': 'Lamotrigine 150 mg; n=1', 'categories': [{'measurements': [{'value': '5418.40', 'groupId': 'OG000', 'lowerLimit': '5418.4', 'upperLimit': '5418.4'}]}]}, {'title': 'Lamotrigine 200 mg; n=78', 'categories': [{'measurements': [{'value': '4092.30', 'groupId': 'OG000', 'lowerLimit': '131.0', 'upperLimit': '11053.2'}]}]}, {'title': 'Lamotrigine 225 mg; n=1', 'categories': [{'measurements': [{'value': '3594.25', 'groupId': 'OG000', 'lowerLimit': '2879.3', 'upperLimit': '4309.2'}]}]}, {'title': 'Lamotrigine 300 mg; n=7', 'categories': [{'measurements': [{'value': '5127.10', 'groupId': 'OG000', 'lowerLimit': '3349.4', 'upperLimit': '12066.6'}]}]}, {'title': 'Lamotrigine 400 mg; n=4', 'categories': [{'measurements': [{'value': '8600.40', 'groupId': 'OG000', 'lowerLimit': '4722.2', 'upperLimit': '10830.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from Week 6 to Week 52/EW', 'description': 'PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Participants without concomitant use of inhibitor and inducer from the date of the first dose of study medication to the date of the last dose. Multiple blood samplings were conducted for some participants. A total of 82 participants were analyzed; 4 participants did not have 200 mg dose data but had data for lower doses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lamotrigine - Dosage Adjustment Phase', 'description': 'Lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation'}, {'id': 'FG001', 'title': 'Lamotrigine - Long-term Administration Phase', 'description': 'Lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'periods': [{'title': '6-week Dosage Adjustment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '46-week Long-term Administration Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol-defined Stopping Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lamotrigine', 'description': 'Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '12.11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian - Japanese Heritage', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2007-11-28', 'resultsFirstSubmitDate': '2011-06-30', 'studyFirstSubmitQcDate': '2007-11-28', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-06-30', 'studyFirstPostDateStruct': {'date': '2007-11-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Any Serious Adverse Event (SAE) and Any Non Serious Adverse Event', 'timeFrame': 'From baseline (Week 0) until 2 weeks after the end of treatment (Week 54)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of medicinal product, which does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes its prolongation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. A complete list of all SAEs and AEs experienced in the study can be found in the SAE/AE section.'}, {'measure': 'Number of Participants With the Indicated Clinical Laboratory Test Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH)', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/Early Withdrawal (EW)', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: ALP, ALT, AST, GGT, and LDH. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: ALP, 104-338 International Units per liter (IU/L); ALT, 5-45 IU/L; AST, 10-40 IU/L; GGT, Male: 0-79 IU/L, Female: 0-48 IU/L; LDH 120-245 IU/L.'}, {'measure': 'Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Bilirubin and Creatinine at Weeks 0, 6, 16, 28, 40, and 52/EW', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters at the indicated time points: total bilirubin and creatinine. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: total bilirubin, 3.42-17.1 micromoles per liter (UMOL/L); creatinine, Male: 57.46-96.356 UMOL/L, Female: 40.664-72.488 UMOL/L.'}, {'measure': 'Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Calcium, Cholesterol, Chloride, Potassium, Sodium, Triglycerides, and Urea/Blood Urea Nitrogen (BUN) at Weeks 0, 6, 16, 28, 40, and 52/EW', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'Participants were evaluated for the following clinical laboratory parameters for blood chemistry at the indicated time points: electrolytes (calcium, chloride, potassium, sodium), cholesterol, triglycerides, and urea/BUN. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges (micromoles per liter \\[MMOL/L\\]): calcium, 2.0459-2.495; chloride, 98-108; potassium, 3.5-5; sodium, 135-145; cholesterol, 3.879-5.66334; triglycerides, 0.565-1.6837; urea/BUN, 2.856-7.14.'}, {'measure': 'Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Platelet Count and White Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'Participants in the study were evaluated for the following clinical laboratory parameters of hematology at the indicated time points: platelet count and white blood cell count. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: platelet count, 140-379 GI (gibi; 10\\^9) per liter (GI/L); white blood cell count, 3.5-9.7 GI/L.'}, {'measure': 'Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Total Protein, Hemoglobin, and Hematocrit at Weeks 0, 6, 16, 28, 40, and 52/EW', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'Participants in the study were evaluated for total protein, hemoglobin, and hematocrit at the indicated time points. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: total protein, 65-82 grams per liter (G/L); hemoglobin, Male: 136-183 G/L, Female: 112-152 G/L; hematocrit (proportion of 1), Male: 0.404-0.519, Female: 0.343-0.452.'}, {'measure': 'Number of Participants With Clinical Laboratory Test Values Out of the Normal Range and in the Normal Range for Red Blood Cell Count at Weeks 0, 6, 16, 28, 40, and 52/EW', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'Red blood cell count was measured in participants at the indicated time points. Participants were categorized as "High" for laboratory values above normal (reference) and as "Low" for laboratory values below normal ranges used by the central laboratory. Normal ranges: red blood cell count, Male: 4.38-5.77 TI (tebi; 10\\^12)/L, Female: 3.76-5.16 TI/L.'}, {'measure': 'Number of Participants in the Indicated Category for Urine Glucose, Urine Protein, and Urine Urobilinogen at Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'Urine glucose, urine protein, and urine urobilinogen were measured in participants at the indicated time points. In this dipstick (qualitative) test, the level of glucose, protein, and urobilinogen in urine samples was recorded as negative (NEG \\[-\\]), trace (TRA \\[+/-\\]), 1+, 2+, 3+, 4+, and 5+ (the plus sign increases with a higher level of glucose, protein, or urobilinogen in the urine: 1+=slightly positive, 2+=positive, 3+=high positive, 4+=very high positive, 5+=more positive than 4+).'}, {'measure': 'Mean Systolic Blood Pressure and Diastolic Blood Pressure of Participants at Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'timeFrame': 'Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'description': 'Systolic and diastolic blood pressure was measured in participants at the indicated time points.'}, {'measure': 'Mean Heart Rate of Participants at Week 0 (Baseline) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'timeFrame': 'Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'description': 'Heart rate was measured in participants at the indicated time points.'}, {'measure': 'Mean Weight of Participants at Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'description': 'The weight of participants was recorded at the indicated time points.'}, {'measure': 'Mean Body Mass Index (BMI) of All Participants at Week 0 (Baseline) and Weeks 6, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48, and 52/EW', 'timeFrame': 'Baseline (Week 0) and Weeks 0, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'description': 'The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.'}, {'measure': 'Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 0, 6, 28, and 52/EW', 'timeFrame': 'Weeks 0, 6, 28, and 52/EW', 'description': 'ECGs were recorded in participants at the indicated time points. ECG findings, as determined by the physicians, were reported as normal, abnormal but not clinically significant (NCS), abnormal but clinically significant (CS), and no result. Specific definitions of ECG categorizations were not provided; physicians were expected to apply reasonable standards of clinical judgment.'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'timeFrame': 'Weeks 0, 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'description': "The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. The number of participants with an assessment varied depending on the number of assessments completed at each visit (indicated time points)."}, {'measure': 'Change From Baseline in the Clinical Global Impressions of Severity (CGI-S) Total Score at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'timeFrame': 'Baseline (Week 0) and Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52/EW', 'description': "The CGI-S is a standardized assessment tool that uses a 7-point scale to assess a participant's severity of illness. The total score ranges from 0 to 7: 0=not assessed, 1=normal, 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severly ill, 7=extremely ill. Higher scores reflect a higher severity of current illness states. Change from baseline was calculated as the values at Weeks 2, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 (or EW) minus the baseline value (Week 0)."}, {'measure': 'Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW', 'timeFrame': 'Weeks 6, 16, 28, 40, and 52/EW', 'description': 'The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill).'}, {'measure': 'Change From Baseline in the Hamilton Rating Scale for Depression (HAM-D) Scale Total Score at Weeks 6, 16, 28, 40, and 52/EW', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'The HAMD-17 is a 17-item questionnaire that detects change and measures illness severity. Individual items were rated on a scale of 0-4 and 0-2, with the total HAMD-17 score ranging from 0 (not ill) to 52 (severely ill). Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).'}, {'measure': 'Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW', 'timeFrame': 'Weeks 6, 16, 28, 40, and 52/EW', 'description': 'The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. For all items, 0 is the "best" rating and 4 or 8 is the "worst" rating. YMRS total score was computed as the sum of the scores for the 11 items on the scale. The possible total scores range from 0 (best) to 60 (worst).'}, {'measure': 'Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 6, 16, 28, 40, and 52/EW', 'timeFrame': 'Baseline (Week 0) and Weeks 6, 16, 28, 40, and 52/EW', 'description': 'The YMRS is an 11-item, multiple-choice diagnostic questionnaire used to measure the severity of disease in participants. Individual items (1=elevated mood, 2=increased motor activity, 3=sexual interest, 4=sleep, 5=irritability, 6=speech, 7=language thought disorder, 8=content, 9=disruptive aggressive behaviour, 10=appearance, 11=insight) were rated on a scale of 0-4 and 0-8. YMRS total score (range of 0-60) was computed as sum of the scores for the 11 items on the scale. Change from baseline was calculated as the values at Week 6, 16, 28, 40, and 52 (or EW) minus the baseline value (Week 0).'}, {'measure': 'Median Serum Lamotrigine 200 mg Concentration Among Participants With Concomitant Use of Inducer and Without Inhibitor (at the Timing of Blood Sample Collection)', 'timeFrame': 'from Week 6 to Week 52/EW', 'description': 'Pharmacokinetic (PK) samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.'}, {'measure': 'Median Serum Lamotrigine 100 mg and 200 mg Concentration Among Participants With Concomitant Use of Inhibitor (at the Timing of Blood Sample Collection)', 'timeFrame': 'from Week 6 to Week 52/EW', 'description': 'PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.'}, {'measure': 'Median Serum Lamotrigine 25, 100, 125, 150, 200, 225, 300, and 400 mg Concentrations Among Participants Without Concomitant Use of Inhibitor and Inducer', 'timeFrame': 'from Week 6 to Week 52/EW', 'description': 'PK samples were collected at Weeks 6, 16, 28, 40, 52/EW, and the plasma lamotrigine concentrations were measured. Participants were required to visit the study site without taking the investigational product on the morning of the PK blood sampling. Inhibitors are defined as drugs that inhibit lamotrigine glucuronidation (i.e., valproate). Inducers are defined as drugs that induce lamotrigine glucuronidation (e.g., carbamazepine). The median value presented is the median of all samples collected at Weeks 6, 16, 28, 40, and 52/EW.'}]}, 'conditionsModule': {'keywords': ['Open-label extension', 'Tolerability', 'Lamotrigine', 'Safety', 'Bipolar I disorder'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'availIpds': [{'id': 'SCA106052', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'SCA106052', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'SCA106052', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'SCA106052', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'type': 'BACKGROUND', 'citation': 'Tsukasa Koyama, Teruhiko Higuchi, Shigeto Yamawaki, Shigenobu Kanba, Takeshi Terao and Atsuko Shinohara. Study SCA106052, a clinical evaluation of BW430C (lamotrigine) in bipolar I disorder - Long-term extension study -. Rinsho seishin igaku. 2011;40(7):981-995.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This study is planned to assess the long-term safety of lamotrigine in Japanese patients with bipolar I disorder who will continue into the 52-week extension upon completion of a double-blind comparative study (Study No.: SCA104779 (NCT00550407)), i.e. the patients who receive the addition of any additional treatment to intervene in a mood episode in the double-blind phase or the patients completing the double-blind phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Of subjects participating in the preceding double-blind study, those who are judged by the investigator/sub-investigator to have well tolerated the double-blind treatment and to be eligible for the 52-week extension treatment\n* Sex: either sex. Female of child-bearing potential will be eligible for inclusion in this study. However they have to have a negative pregnancy test at the start of this study, agree to further pregnancy testing at the time points determined in study assessments and procedures and practice one of the following methods of contraception from the start of this study until the end of the follow-up examination:\n\nAbstinence\n\nOral contraceptive, either combined or progestogen alone (except during the Dosage Adjustment Phase)\n\nInjectable progestogen\n\nImplants of levonorgestrel\n\nEstrogenic vaginal ring (except during the Dosage Adjustment Phase)\n\nPercutaneous contraceptive patches (except during the Dosage Adjustment Phase)\n\nIntrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label\n\nMale partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject\'s entry into the study, and this male is the sole partner for that subject\n\nDouble barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (foam / gel / film / cream / suppository)\n\n* In/Out patient: Either\n* Informed consent: the subject capable of giving written informed consent\n\nExclusion Criteria:\n\n* Has a score of 3 or more on item of the HAM-D related to suicide or is at a high suicidal risk in the judgment of the investigator/sub-investigator\n* Has a history of severe rash or rash due to anti-epileptic drugs\n* Patients with severe hepatic/renal/cardiac/pulmonary disorder or hematopoietic disorder. The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences" (PAB/SD Notification No. 80, dated 29 June 1992)\n* Patients have less than 5 years of remission history from clinically significant malignancy (other than e.g. basal cell or squamous cell skin cancer, in-situ carcinoma of cervix or prostate CA in situ)\n* Patients with chronic hepatitis typeB and /or typeC which is positive of hepatitis B surface antigen （HBsAg）and/or hepatitis C antibody\n* Has an acute or chronic illness likely to impair drug absorption, distribution, metabolism or excretion or has any unstable physical symptoms likely to require hospitalisation during participation in the study\n* Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study\n* Has a history or current diagnosis of epilepsy\n* Has received an investigational drug within 30 days of screening\n* Patients with a history of drug allergy to any ingredient of the test-drug\n* Patients whom the investigator or sub-investigator considers ineligible for the study'}, 'identificationModule': {'nctId': 'NCT00566020', 'briefTitle': 'A Clinical Evaluation Of BW430C (Lamotrigine) In Bipolar I Disorder- Long-term Extension Of Study SCA104779 (NCT00550407) -', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Study SCA106052, a Clinical Evaluation of BW430C (Lamotrigine) in Bipolar I Disorder- Long-term Extension Study (Extension of Study SCA104779 (NCT00550407))', 'orgStudyIdInfo': {'id': 'SCA106052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lamotrigine', 'description': 'study drug', 'interventionNames': ['Drug: BW430C (lamotrigine)']}], 'interventions': [{'name': 'BW430C (lamotrigine)', 'type': 'DRUG', 'description': 'lamotrigine 50mg/day-400mg/day', 'armGroupLabels': ['Lamotrigine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '470-1141', 'city': 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