Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:12 PM
Study NCT ID:
NCT00234832
Status:
COMPLETED
Last Update Posted:
2010-05-11
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients
Sponsor:
Organization:
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': 'C058254', 'term': 'sibutramine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Most subjects not indicated for sibutramine (sbt) due to CV disease. Long-term sbt use (6 yrs) regardless of weight loss, is inconsistent with label (limits use to 1-2 yrs \\& 5% weight loss). Trial lacked true placebo; all received Lead-in Period sbt.'}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose.', 'description': 'SAEs confirmed to be outcome events are included.\n\nLead-in Period SAEs occurring on or after the first dose of sibutramine during the Lead-in Period through 30 days after the last dose of sibutramine for subjects who discontinued or through 30 days into the Randomization Phase for subjects who were randomized are included.', 'eventGroups': [{'id': 'EG000', 'title': 'Lead-in Period Sibutramine', 'description': 'Subjects who received sibutramine 10 mg QD plus standard care for weight management during a 6-week Lead-in Period.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 10744, 'seriousNumAffected': 425}, {'id': 'EG001', 'title': 'Randomized Sibutramine', 'description': 'Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive sibutramine plus standard care for weight management during the Treatment Period of the Randomization Phase, and if sibutramine was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 4904, 'seriousNumAffected': 2063}, {'id': 'EG002', 'title': 'Randomized Placebo', 'description': 'Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive placebo plus standard care for weight management during the Treatment Period of the Randomizaiton Phase, and if placebo was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 4881, 'seriousNumAffected': 1977}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bicytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hemolytic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hemorrhagic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hemorrhagic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypersplenism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypochromic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypoprothrombinanemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Idiopathic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Iron deficiency anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lymphatic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lymphocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Microcytic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Normochromic normocytic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 26}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 87}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 87}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Adams-Stokes syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 111}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 133}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 122}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 104}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Aortic valve disease mixed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 115}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 135}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 29}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiac aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiac asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 80}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiac failure acute', 'stats': 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'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 39}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Peripheral ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Phlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Post thrombotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Shock hemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Subclavian artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Subclavian artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Subclavian steal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Temporal arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thromboangiitis obliterans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Varicophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Varicose ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vascular rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vascular shunt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vascular stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vasculitis necrotizing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Venous insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10744, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4904, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4881, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4906', 'groupId': 'OG000'}, {'value': '4898', 'groupId': 'OG001'}, {'value': '1207', 'groupId': 'OG002'}, {'value': '1178', 'groupId': 'OG003'}, {'value': '759', 'groupId': 'OG004'}, {'value': '793', 'groupId': 'OG005'}, {'value': '2906', 'groupId': 'OG006'}, {'value': '2901', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Sibutramine', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}, {'id': 'OG001', 'title': 'Randomized Placebo', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}, {'id': 'OG002', 'title': 'DM Only Randomized to Sibutramine', 'description': 'Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.'}, {'id': 'OG003', 'title': 'DM Only Randomized to Placebo', 'description': 'Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.'}, {'id': 'OG004', 'title': 'CV Only Randomized to Sibutramine', 'description': 'Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.'}, {'id': 'OG005', 'title': 'CV Only Randomized to Placebo', 'description': 'Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.'}, {'id': 'OG006', 'title': 'CV + DM Randomized to Sibutramine', 'description': 'Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.'}, {'id': 'OG007', 'title': 'CV + DM Randomized to Placebo', 'description': 'Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.'}], 'classes': [{'title': 'Intent-to-treat population', 'categories': [{'measurements': [{'value': '561', 'groupId': 'OG000'}, {'value': '490', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '77', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}, {'value': '403', 'groupId': 'OG006'}, {'value': '346', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.162', 'ciLowerLimit': '1.029', 'ciUpperLimit': '1.311', 'pValueComment': 'No adjustment for multiple testing or interim analysis was performed. The primary outcome was tested at a 2-sided alpha level of 0.05.', 'estimateComment': 'The Cox model included factors for treatment, country, gender, and age (continuous) at Lead-in Period baseline. For the calculation of risk, the sibutramine arm is the numerator and the placebo arm is the denominator.', 'groupDescription': 'For the sample size calculation, a two-tailed alpha level of 0.05 was used along with power of 90%. The annual composite event rate in the placebo arm was assumed to be 7.0%. A sample of 3983 subjects in each of the 2 groups, corrected for a 30% noncompliance rate (15% in Year 1 and 6.3% in each year, Years 2 to 4), followed for at least 3 years was expected to have 90% power to detect a relative risk reduction of 15% with sibutramine relative to placebo.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.948', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.010', 'ciLowerLimit': '0.738', 'ciUpperLimit': '1.384', 'groupDescription': 'This analysis included only subjects with DM only in a comparison of sibutramine and placebo.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.149', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.276', 'ciLowerLimit': '0.916', 'ciUpperLimit': '1.776', 'groupDescription': 'This analysis included only subjects with CV only in a comparison of sibutramine and placebo.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.022', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.182', 'ciLowerLimit': '1.024', 'ciUpperLimit': '1.365', 'groupDescription': 'This analysis included only subjects with CV + DM in a comparison of sibutramine and placebo.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to 6 years', 'description': 'For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on intent-to-treat (ITT) population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized. Subjects were also categorized into 1 of 3 prespecified CV risk groups: diabetes mellitus (DM) only, CV only, and CV + DM.'}, {'type': 'SECONDARY', 'title': 'Risk of Death From Any Cause (All-cause Mortality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4906', 'groupId': 'OG000'}, {'value': '4898', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Sibutramine', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}, {'id': 'OG001', 'title': 'Randomized Placebo', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '418', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.543', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.043', 'ciLowerLimit': '0.910', 'ciUpperLimit': '1.196', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to 6 years', 'description': 'For each subject who died, the time to death was evaluated using time-to-event analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Risk of Experiencing a POE or a Revascularization Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4906', 'groupId': 'OG000'}, {'value': '4898', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Sibutramine', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}, {'id': 'OG001', 'title': 'Randomized Placebo', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '927', 'groupId': 'OG000'}, {'value': '856', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.051', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.097', 'ciLowerLimit': '0.999', 'ciUpperLimit': '1.204', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to 6 years', 'description': 'This outcome includes nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, CV death (including events such as fatal MI and fatal stroke), and any of the following revascularization procedures: percutaneous transluminal coronary angioplasty, coronary artery bypass graft, coronary artery stent placement, cardiac transplant, peripheral vascular bypass or angioplasty, and carotid endarterectomy. For each subject, the POE or revascularization status (yes/no) and time to first occurrence of an event using time-to-event analysis were evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Risk of Experiencing a Nonfatal MI Included in the POE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4906', 'groupId': 'OG000'}, {'value': '4898', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Sibutramine', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}, {'id': 'OG001', 'title': 'Randomized Placebo', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.276', 'ciLowerLimit': '1.036', 'ciUpperLimit': '1.571', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to 6 years', 'description': 'For each subject, the first occurrence of a nonfatal MI included in the POE was evaluated using time-to-event analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Risk of Experiencing a Nonfatal Stroke Included in the POE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4906', 'groupId': 'OG000'}, {'value': '4898', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Sibutramine', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}, {'id': 'OG001', 'title': 'Randomized Placebo', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.355', 'ciLowerLimit': '1.038', 'ciUpperLimit': '1.767', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to 6 years', 'description': 'For each subject, the time to first occurrence of a nonfatal stroke included in the POE was evaluated using time-to-event analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4906', 'groupId': 'OG000'}, {'value': '4898', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Sibutramine', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}, {'id': 'OG001', 'title': 'Randomized Placebo', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.343', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.582', 'ciLowerLimit': '0.613', 'ciUpperLimit': '4.081', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to 6 years', 'description': 'For each subject, the time to first occurrence of a resuscitated cardiac arrest included in the POE was evaluated using time-to-event analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Risk of Experiencing Cardiovascular Death Included in the POE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4906', 'groupId': 'OG000'}, {'value': '4898', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Sibutramine', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}, {'id': 'OG001', 'title': 'Randomized Placebo', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '223', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.899', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.988', 'ciLowerLimit': '0.822', 'ciUpperLimit': '1.188', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to 6 years', 'description': 'For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis based on ITT population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Randomized Sibutramine', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}, {'id': 'FG001', 'title': 'Randomized Placebo', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Subjects completed the 6-week Lead-in Period and were dispensed randomized study drug.', 'groupId': 'FG000', 'numSubjects': '4906'}, {'comment': 'Subjects completed the 6-week Lead-in Period and were dispensed randomized study drug.', 'groupId': 'FG001', 'numSubjects': '4898'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Subjects completed the Randomization Phase.', 'groupId': 'FG000', 'numSubjects': '3890'}, {'comment': 'Subjects completed the Randomization Phase.', 'groupId': 'FG001', 'numSubjects': '3902'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1016'}, {'groupId': 'FG001', 'numSubjects': '996'}]}]}], 'preAssignmentDetails': 'Of the 10777 subjects enrolled into the study, 33 were not treated with Lead-in Period sibutramine. Of the 10744 subjects who took at least 1 dose of Lead-in Period sibutramine, 939 were not randomized. One of the remaining 9805 subjects was not dispensed randomized study drug and was not included in the intent-to-treat population (N = 9804).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4906', 'groupId': 'BG000'}, {'value': '4898', 'groupId': 'BG001'}, {'value': '9804', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Randomized Sibutramine', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}, {'id': 'BG001', 'title': 'Randomized Placebo', 'description': 'Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3040', 'groupId': 'BG000'}, {'value': '2997', 'groupId': 'BG001'}, {'value': '6037', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1866', 'groupId': 'BG000'}, {'value': '1901', 'groupId': 'BG001'}, {'value': '3767', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '6.09', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '6.15', 'groupId': 'BG001'}, {'value': '63.2', 'spread': '6.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2099', 'groupId': 'BG000'}, {'value': '2055', 'groupId': 'BG001'}, {'value': '4154', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2807', 'groupId': 'BG000'}, {'value': '2843', 'groupId': 'BG001'}, {'value': '5650', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Europe', 'categories': [{'measurements': [{'value': '4160', 'groupId': 'BG000'}, {'value': '4150', 'groupId': 'BG001'}, {'value': '8310', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '384', 'groupId': 'BG000'}, {'value': '385', 'groupId': 'BG001'}, {'value': '769', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '467', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cardiovascular (CV) risk group status', 'classes': [{'title': 'DM only', 'categories': [{'measurements': [{'value': '1207', 'groupId': 'BG000'}, {'value': '1178', 'groupId': 'BG001'}, {'value': '2385', 'groupId': 'BG002'}]}]}, {'title': 'CV only', 'categories': [{'measurements': [{'value': '759', 'groupId': 'BG000'}, {'value': '793', 'groupId': 'BG001'}, {'value': '1552', 'groupId': 'BG002'}]}]}, {'title': 'CV + DM', 'categories': [{'measurements': [{'value': '2906', 'groupId': 'BG000'}, {'value': '2901', 'groupId': 'BG001'}, {'value': '5807', 'groupId': 'BG002'}]}]}, {'title': 'Unknown CV risk group status', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Subjects were categorized at study entry into 1 of 3 prespecified CV risk groups: 1) diabetes mellitus (DM) only = history of type 2 DM with at least one other risk factor but no history of CV disease, 2) CV only = history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor, and 3) CV + DM = history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and a history of type 2 DM with at least one other risk factor.', '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': 10777}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-06', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2010-03-26', 'studyFirstSubmitQcDate': '2005-10-07', 'lastUpdatePostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-26', 'studyFirstPostDateStruct': {'date': '2005-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)', 'timeFrame': 'From randomization up to 6 years', 'description': 'For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.'}], 'secondaryOutcomes': [{'measure': 'Risk of Death From Any Cause (All-cause Mortality)', 'timeFrame': 'From randomization up to 6 years', 'description': 'For each subject who died, the time to death was evaluated using time-to-event analysis.'}, {'measure': 'Risk of Experiencing a POE or a Revascularization Procedure', 'timeFrame': 'From randomization up to 6 years', 'description': 'This outcome includes nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, CV death (including events such as fatal MI and fatal stroke), and any of the following revascularization procedures: percutaneous transluminal coronary angioplasty, coronary artery bypass graft, coronary artery stent placement, cardiac transplant, peripheral vascular bypass or angioplasty, and carotid endarterectomy. For each subject, the POE or revascularization status (yes/no) and time to first occurrence of an event using time-to-event analysis were evaluated.'}, {'measure': 'Risk of Experiencing a Nonfatal MI Included in the POE', 'timeFrame': 'From randomization up to 6 years', 'description': 'For each subject, the first occurrence of a nonfatal MI included in the POE was evaluated using time-to-event analysis.'}, {'measure': 'Risk of Experiencing a Nonfatal Stroke Included in the POE', 'timeFrame': 'From randomization up to 6 years', 'description': 'For each subject, the time to first occurrence of a nonfatal stroke included in the POE was evaluated using time-to-event analysis.'}, {'measure': 'Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE', 'timeFrame': 'From randomization up to 6 years', 'description': 'For each subject, the time to first occurrence of a resuscitated cardiac arrest included in the POE was evaluated using time-to-event analysis.'}, {'measure': 'Risk of Experiencing Cardiovascular Death Included in the POE', 'timeFrame': 'From randomization up to 6 years', 'description': 'For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'Sibutramine'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '24534073', 'type': 'DERIVED', 'citation': 'Jorgensen ME, Torp-Pedersen C, Finer N, Caterson I, James WP, Legler UF, Andersson C. Association between serum bilirubin and cardiovascular disease in an overweight high risk population from the SCOUT trial. Nutr Metab Cardiovasc Dis. 2014 Jun;24(6):656-62. doi: 10.1016/j.numecd.2013.12.009. Epub 2014 Jan 18.'}, {'pmid': '24406481', 'type': 'DERIVED', 'citation': 'Seimon RV, Espinoza D, Ivers L, Gebski V, Finer N, Legler UF, Sharma AM, James WP, Coutinho W, Caterson ID. Changes in body weight and blood pressure: paradoxical outcome events in overweight and obese subjects with cardiovascular disease. Int J Obes (Lond). 2014 Sep;38(9):1165-71. doi: 10.1038/ijo.2014.2. Epub 2014 Jan 10.'}, {'pmid': '20818901', 'type': 'DERIVED', 'citation': 'James WP, Caterson ID, Coutinho W, Finer N, Van Gaal LF, Maggioni AP, Torp-Pedersen C, Sharma AM, Shepherd GM, Rode RA, Renz CL; SCOUT Investigators. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med. 2010 Sep 2;363(10):905-17. doi: 10.1056/NEJMoa1003114.'}, {'pmid': '20184783', 'type': 'DERIVED', 'citation': 'Weeke P, Andersson C, Fosbol EL, Brendorp B, Kober L, Sharma AM, Finer N, James PT, Caterson ID, Rode RA, Torp-Pedersen C. The weight lowering effect of sibutramine and its impact on serum lipids in cardiovascular high risk patients with and without type 2 diabetes mellitus - an analysis from the SCOUT lead-in period. BMC Endocr Disord. 2010 Feb 26;10:3. doi: 10.1186/1472-6823-10-3.'}, {'pmid': '19828038', 'type': 'DERIVED', 'citation': 'Andersson C, Weeke P, Brendorp B, Kober L, Fosbol EL, Sharma AM, Finer N, Caterson ID, Rode RA, James PT, Torp-Pedersen C. Differential changes in serum uric acid concentrations in sibutramine promoted weight loss in diabetes: results from four weeks of the lead-in period of the SCOUT trial. Nutr Metab (Lond). 2009 Oct 14;6:42. doi: 10.1186/1743-7075-6-42.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to determine the long-term effect of sibutramine treatment on cardiovascular outcomes in overweight and obese patients at risk of a cardiovascular event.', 'detailedDescription': 'The study consisted of 4 periods: 1) a Screening Period of approximately 2 weeks; 2) a 6-week Lead-in Period, during which subjects received single-blind sibutramine and country-specific standard of care for weight management. Subjects who discontinued study drug treatment during the Lead-in Period were not randomized and did not participate in the double-blind Treatment Period or the Follow-up Period; 3) a double-blind Treatment Period in which subjects were randomized to 1 of the 2 treatment groups and were followed until the study ended; and 4) a double-blind Follow-up Period, during which randomized subjects who discontinued study drug were followed until the study ended. The Randomization Phase consisted of the double-blind Treatment Period and the double-blind Follow-up Period. Subjects received country-specific standard of care for weight management during the Randomization Phase.\n\nAn independent events adjudication committee evaluated all potential cardiovascular outcome events and confirmed the outcome events and time of onset to be included in the statistical analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject's body mass index (BMI) was \\>= 27 kg/m(2) and \\<= 45 kg/m(2) or their BMI was \\>= 25 kg/m(2) and \\< 27 kg/m(2) with waist circumference of \\>= 102 cm in males or \\>= 88 cm in females.\n* Medical history positive for:\n\n * Preexisting cardiovascular disease (i.e., coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease) and/or\n * Type 2 diabetes mellitus with at least 1 other risk factor (i.e., dyslipidemia, controlled hypertension, current smoker, or diabetic nephropathy with evidence of microalbuminuria)\n\nExclusion Criteria:\n\n* History of recent myocardial infarction.\n* Heart failure symptoms greater than New York Heart Association Functional Class II.\n* Hemodynamically significant valvular or left ventricular (LV) tract obstruction.\n* Subjects without a pacemaker and with any of the following:\n\n * Sinus bradycardia (\\< 50 bpm)\n * Sick sinus syndrome\n * Atrioventricular block of more than 1st degree\n* Mean sitting systolic blood pressure (SBP) \\> 160 mmHg. Mean sitting diastolic blood pressure (DBP) \\> 100 mmHg. Mean sitting heart rate (HR) \\> 100 bpm.\n* Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias.\n* Planned cardiac surgery or coronary angioplasty within 6 months of screening.\n* History of recent non-hemorrhagic stroke or transient ischemic attack (TIA), history of hemorrhagic stroke.\n* Hyperthyroidism.\n* Known chronic liver disease or endstage renal disease.\n* Severe, symptomatic benign prostatic hyperplasia which may require surgery.\n* Known pheochromocytoma, history of narrow angle glaucoma, Gilles de la Tourette syndrome, history of seizures, history of bariatric or abdominal obesity surgery (excluding liposuction).\n* Concomitant use of monoamine oxidase inhibitors or drugs that increase levels of serotonin in the brain.\n* Treated hypertension stabilized for less than 3 months.\n* Inability to perform regular physical activity."}, 'identificationModule': {'nctId': 'NCT00234832', 'acronym': 'SCOUT', 'briefTitle': 'A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event', 'orgStudyIdInfo': {'id': 'M01-392'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sibutramine', 'description': 'Subjects were randomized to receive sibutramine 10 mg once daily (QD) during the Treatment Period after a 6-week Lead-in Period', 'interventionNames': ['Drug: Sibutramine hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects were randomized to receive placebo QD during the Treatment Period after a 6-week Lead-in Period', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Lead-in sibutramine', 'description': 'All subjects received 10 mg sibutramine QD during a 6-week Lead-in Period', 'interventionNames': ['Drug: Sibutramine hydrochloride']}], 'interventions': [{'name': 'Sibutramine hydrochloride', 'type': 'DRUG', 'otherNames': ['ABT-991', 'sibutramine', 'Meridia', 'Reductil'], 'description': "One 10 mg tablet QD plus country-specific standard care for weight management. (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)", 'armGroupLabels': ['Sibutramine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': "1 tablet QD plus country-specific standard care for weight management (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)", 'armGroupLabels': ['Placebo']}, {'name': 'Sibutramine hydrochloride', 'type': 'DRUG', 'description': '10 mg tablet QD during the 6-week Lead-in Period plus country-specific standard care for weight management', 'armGroupLabels': ['Lead-in sibutramine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60064', 'city': 'North Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Global Medical Services', 'geoPoint': {'lat': 42.32558, 'lon': -87.84118}}], 'overallOfficials': [{'name': 'Cheryl Renz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Cheryl Renz, MD', 'oldOrganization': 'Abbott'}}}}