Viewing Study NCT00796367

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Ignite Creation Date: 2025-12-25 @ 12:43 AM
Ignite Modification Date: 2025-12-25 @ 10:55 PM
Study NCT ID: NCT00796367
Status: COMPLETED
Last Update Posted: 2012-09-10
First Post: 2008-11-20
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576188', 'term': 'Qsymia'}, {'id': 'C577572', 'term': 'Qnexa'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'day@vivus.com', 'phone': '650.934.5200', 'title': 'Wesley W Day, PhD', 'organization': 'Vivus, Inc'}, 'certainAgreement': {'otherDetails': "After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution \\& PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 227, 'otherNumAffected': 182, 'seriousNumAtRisk': 227, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'VI-0521 Mid', 'description': 'VI-0521 7.5 mg PHEN/46 mg TPM', 'otherNumAtRisk': 153, 'otherNumAffected': 111, 'seriousNumAtRisk': 153, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'VI-0521 Top', 'description': 'VI-0521 15 mg PHEN/92 mg TPM', 'otherNumAtRisk': 295, 'otherNumAffected': 234, 'seriousNumAtRisk': 295, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'tooth ache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'dyslipidemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'abdominal bruit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 6}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'hemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'ischemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'peptic ulcer hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'inguinal hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'nephritic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'renal failure, acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'mesothelioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'serositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'acute cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 295, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Weight Change at End of Treatment, Week 108.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'VI-0521 Mid', 'description': 'VI-0521 7.5 mg phentermine/46 mg topiramate'}, {'id': 'OG002', 'title': 'VI-0521 Top', 'description': 'VI-0521 15 mg phentermine/92 mg topiramate'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-9.32', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '-10.5', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.71', 'ciLowerLimit': '7.39', 'ciUpperLimit': '10.03', 'pValueComment': 'Intersection-union method applied in a step-down testing approach', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.673', 'groupDescription': 'No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.52', 'ciLowerLimit': '5.95', 'ciUpperLimit': '9.09', 'pValueComment': 'Intersection-union method applied in a step-down testing approach', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.799', 'groupDescription': 'No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1189', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '2.68', 'pValueComment': 'Intersection-union method applied in a step-down testing approach', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.760', 'groupDescription': 'No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to end of treatment', 'unitOfMeasure': 'percent weight loss', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Last observation carried forward (ITT-LOCF)'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'OG001', 'title': 'VI-0521 Mid', 'description': 'VI-0521 7.5 mg phentermine/46 mg topiramate'}, {'id': 'OG002', 'title': 'VI-0521 Top', 'description': 'VI-0521 15 mg phentermine/92 mg topiramate'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '75.2', 'groupId': 'OG001'}, {'value': '79.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.4', 'ciLowerLimit': '6.24', 'ciUpperLimit': '14.16', 'pValueComment': 'Intersection-union method applied in a step-down testing approach', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.97', 'groupDescription': 'No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.99', 'ciLowerLimit': '4.36', 'ciUpperLimit': '11.19', 'pValueComment': 'Intersection-union method applied in a step-down testing approach', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.68', 'groupDescription': 'No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2169', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.84', 'ciUpperLimit': '2.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'groupDescription': 'No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to End of Treatment', 'unitOfMeasure': 'percent participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat Last-observation-carried-forward (ITT-LOCF)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'FG001', 'title': 'VI-0521 Mid', 'description': 'VI-0521 7.5 mg PHEN/46 mg TPM'}, {'id': 'FG002', 'title': 'VI-0521 Top', 'description': 'VI-0521 15 mg PHEN/92 mg TPM'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'comment': 'one participant signed ICF but withdrew from study prior to first dosing in OB-305', 'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '295'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '129'}, {'groupId': 'FG002', 'numSubjects': '248'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'non compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Requirement for restricted medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Subjects were from OB-303 (NCT00553787)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}, {'value': '675', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG001', 'title': 'VI-0521 Mid', 'description': 'VI-0521 7.5 mg PHEN/46 mg TPM'}, {'id': 'BG002', 'title': 'VI-0521 Top', 'description': 'VI-0521 15 mg PHEN/92 mg TPM'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '52.2', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '51.2', 'spread': '10.4', 'groupId': 'BG002'}, {'value': '51.9', 'spread': '10.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}, {'value': '448', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}, {'value': '675', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 676}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'dispFirstSubmitDate': '2011-05-13', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-05', 'studyFirstSubmitDate': '2008-11-20', 'dispFirstSubmitQcDate': '2011-05-13', 'resultsFirstSubmitDate': '2012-07-31', 'studyFirstSubmitQcDate': '2008-11-21', 'dispFirstPostDateStruct': {'date': '2011-05-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-31', 'studyFirstPostDateStruct': {'date': '2008-11-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Weight Change at End of Treatment, Week 108.', 'timeFrame': 'From baseline to end of treatment'}, {'measure': 'Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.', 'timeFrame': 'Baseline to End of Treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '28455281', 'type': 'DERIVED', 'citation': 'Guo F, Garvey WT. Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes Care. 2017 Jul;40(7):856-862. doi: 10.2337/dc17-0088. Epub 2017 Apr 28.'}, {'pmid': '22158731', 'type': 'DERIVED', 'citation': 'Garvey WT, Ryan DH, Look M, Gadde KM, Allison DB, Peterson CA, Schwiers M, Day WW, Bowden CH. Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study. Am J Clin Nutr. 2012 Feb;95(2):297-308. doi: 10.3945/ajcn.111.024927. Epub 2011 Dec 7.'}], 'seeAlsoLinks': [{'url': 'http://www.vivus.com/', 'label': 'VIVUS company website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521 compared to placebo for the treatment of overweight and obesity in adults who have completed study OB-303 (NCT00553787) at selected study sites. This is an extension study of protocol OB-303 (NCT00553787).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be eligible for enrollment into this study, subjects must meet all of the following criteria:\n\n* Completion of study OB-303 (NCT00553787) on treatment and compliance with all protocol requirements\n* Written informed consent\n* Female subjects of childbearing potential must be using adequate contraception, defined as double-barrier methods, stable hormonal contraception plus single barrier method, or tubal ligation. Female subjects are considered to be of childbearing potential unless they have undergone a hysterectomy or bilateral oophorectomy, are ≥55 years of age and experienced spontaneous cessation of menses for at least 1 year, or have a documented follicle-stimulating hormone level ≥40 IU/L\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\nSubjects will not be included in the study if they meet any of the following:\n\n* Body mass index ≤22 kg/m2 at the completion of study OB-303\n* Off study medication at completion of study OB-303 (NCT00553787) for longer than 4 weeks continuously due to an event-driven holiday, or off study medication with no plans to restart\n* Development of any condition during study OB-303 (NCT00553787) that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, or confound the interpretation of study results\n* Participation in a formal weight loss program (including: Weight Watchers and related dietary/lifestyle intervention programs; prepared food programs; prescribed or over the counter weight loss medications; dietary supplement or herbal preparations, teas, or tinctures intended for weight loss; or any supervised fast or very low calorie diet).'}, 'identificationModule': {'nctId': 'NCT00796367', 'briefTitle': 'A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)', 'organization': {'class': 'INDUSTRY', 'fullName': 'VIVUS LLC'}, 'officialTitle': 'A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303 [NCT00553787]) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions.', 'orgStudyIdInfo': {'id': 'OB-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'VI-0521 Mid', 'description': '7.5 mg phentermine and 46 mg topiramate', 'interventionNames': ['Drug: VI-0521']}, {'type': 'EXPERIMENTAL', 'label': 'VI-0521 Top', 'description': '15 mg phentermine and 92 mg topiramate', 'interventionNames': ['Drug: VI-0521']}], 'interventions': [{'name': 'VI-0521', 'type': 'DRUG', 'otherNames': ['Qsymia', 'Qnexa', 'PHEN/TPM'], 'description': '7.5 mg phentermine and 46 mg topiramate', 'armGroupLabels': ['VI-0521 Mid']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Placebo']}, {'name': 'VI-0521', 'type': 'DRUG', 'otherNames': ['Qsymia', 'Qnexa', 'PHEN/TPM'], 'description': '15 mg phentermine and 92 mg topiramate', 'armGroupLabels': ['VI-0521 Top']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Craig Peterson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'VIVUS LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VIVUS LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medpace, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}