Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-28 @ 9:36 PM
Study NCT ID:
NCT01574703
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2012-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}, {'id': 'D016642', 'term': 'Bupropion'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).', 'description': 'Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). Four deaths (completed suicide, death, myocardial infarction and upper gastrointestinal haemorrhage) are listed as serious AEs below, included events that began 31 days after the last dose of study drug in study NCT01456936.', 'eventGroups': [{'id': 'EG000', 'title': 'Varenicline', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.', 'otherNumAtRisk': 1192, 'otherNumAffected': 165, 'seriousNumAtRisk': 1192, 'seriousNumAffected': 34}, {'id': 'EG001', 'title': 'Bupropion', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.', 'otherNumAtRisk': 1166, 'otherNumAffected': 160, 'seriousNumAtRisk': 1166, 'seriousNumAffected': 39}, {'id': 'EG002', 'title': 'NRT Patch', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.', 'otherNumAtRisk': 1116, 'otherNumAffected': 116, 'seriousNumAtRisk': 1116, 'seriousNumAffected': 43}, {'id': 'EG003', 'title': 'Placebo', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.', 'otherNumAtRisk': 1121, 'otherNumAffected': 143, 'seriousNumAtRisk': 1121, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 69}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 81}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 63}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Endocrine ophthalmopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Duodenal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Duodenal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Inguinal hernia strangulated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 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0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': "Morton's neuralgia", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1166, 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'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Schizophrenia, paranoid type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Renal failure', 'stats': 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Drug detoxification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1192, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1166, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1121, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2016', 'groupId': 'OG000'}, {'value': '2006', 'groupId': 'OG001'}, {'value': '2022', 'groupId': 'OG002'}, {'value': '2014', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG001', 'title': 'Bupropion', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG002', 'title': 'NRT Patch', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '1.68'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '2.50'}, {'value': '0.29', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '1.70'}, {'value': 'NA', 'comment': 'Hazard ratio relative to Placebo.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'P-value for the treatment effect from the Log-Rank test stratified by Cohort.', 'groupDescription': 'Statistical analysis for overall treatment comparison.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).', 'description': 'This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.', 'unitOfMeasure': 'Unitless', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.'}, {'type': 'SECONDARY', 'title': 'Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2016', 'groupId': 'OG000'}, {'value': '2006', 'groupId': 'OG001'}, {'value': '2022', 'groupId': 'OG002'}, {'value': '2014', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG001', 'title': 'Bupropion', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG002', 'title': 'NRT Patch', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '1.70'}, {'value': '0.51', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '2.51'}, {'value': '0.50', 'groupId': 'OG002', 'lowerLimit': '0.10', 'upperLimit': '2.48'}, {'value': 'NA', 'comment': 'Hazard ratio relative to Placebo.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'P-value for the treatment effect from the Log-Rank test stratified by Cohort.', 'groupDescription': 'Statistical analysis for overall treatment comparison.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.', 'description': 'This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio.', 'unitOfMeasure': 'Unitless', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.'}, {'type': 'SECONDARY', 'title': 'Time to MACE Until the End of Study NCT01574703.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2016', 'groupId': 'OG000'}, {'value': '2006', 'groupId': 'OG001'}, {'value': '2022', 'groupId': 'OG002'}, {'value': '2014', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG001', 'title': 'Bupropion', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG002', 'title': 'NRT Patch', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.39', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '1.27'}, {'value': '1.09', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '2.83'}, {'value': '0.75', 'groupId': 'OG002', 'lowerLimit': '0.26', 'upperLimit': '2.13'}, {'value': 'NA', 'comment': 'Hazard ratio relative to Placebo.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'pValueComment': 'P-value for the treatment effect from the Log-Rank test stratified by Cohort.', 'groupDescription': 'Statistical analysis for overall treatment comparison.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).', 'description': 'This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio.', 'unitOfMeasure': 'Unitless', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.'}, {'type': 'SECONDARY', 'title': 'Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2016', 'groupId': 'OG000'}, {'value': '2006', 'groupId': 'OG001'}, {'value': '2022', 'groupId': 'OG002'}, {'value': '2014', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG001', 'title': 'Bupropion', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG002', 'title': 'NRT Patch', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000'}, {'value': '0.10', 'groupId': 'OG001'}, {'value': '0.05', 'groupId': 'OG002'}, {'value': '0.20', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8375', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-5.22', 'ciUpperLimit': '4.23', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and Bupropion.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9780', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-5.20', 'ciUpperLimit': '5.05', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and NRT patch.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6142', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.13', 'ciLowerLimit': '-5.54', 'ciUpperLimit': '3.27', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8602', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '-4.28', 'ciUpperLimit': '5.13', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Bupropion and NRT patch.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7217', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-4.15', 'ciUpperLimit': '2.88', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Bupropion and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6322', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.06', 'ciLowerLimit': '-5.41', 'ciUpperLimit': '3.28', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between NRT patch and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).', 'description': 'This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.'}, {'type': 'SECONDARY', 'title': 'Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2016', 'groupId': 'OG000'}, {'value': '2006', 'groupId': 'OG001'}, {'value': '2022', 'groupId': 'OG002'}, {'value': '2014', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG001', 'title': 'Bupropion', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG002', 'title': 'NRT Patch', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000'}, {'value': '0.20', 'groupId': 'OG001'}, {'value': '0.10', 'groupId': 'OG002'}, {'value': '0.25', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9687', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-3.48', 'ciUpperLimit': '3.34', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and Bupropion.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7905', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '-3.58', 'ciUpperLimit': '4.70', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and NRT patch.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8962', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-3.36', 'ciUpperLimit': '2.94', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7767', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '-3.72', 'ciUpperLimit': '4.98', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Bupropion and NRT patch.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9260', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-3.13', 'ciUpperLimit': '2.85', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Bupropion and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7113', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.77', 'ciLowerLimit': '-4.85', 'ciUpperLimit': '3.31', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between NRT patch and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).', 'description': 'This is an adjudicated endpoint. 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However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG001', 'title': 'Bupropion', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG002', 'title': 'NRT Patch', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000'}, {'value': '0.10', 'groupId': 'OG001'}, {'value': '0.10', 'groupId': 'OG002'}, {'value': '0.20', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8117', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-5.27', 'ciUpperLimit': '4.13', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and Bupropion.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7303', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.78', 'ciLowerLimit': '-5.21', 'ciUpperLimit': '3.65', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and NRT patch.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5946', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.20', 'ciLowerLimit': '-5.60', 'ciUpperLimit': '3.21', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9200', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-4.27', 'ciUpperLimit': '3.85', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Bupropion and NRT patch.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7236', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-4.09', 'ciUpperLimit': '2.84', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Bupropion and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8201', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-4.01', 'ciUpperLimit': '3.17', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between NRT patch and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.', 'description': 'This is an adjudicated endpoint. 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However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG001', 'title': 'Bupropion', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG002', 'title': 'NRT Patch', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000'}, {'value': '0.20', 'groupId': 'OG001'}, {'value': '0.15', 'groupId': 'OG002'}, {'value': '0.35', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8932', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-3.22', 'ciUpperLimit': '2.81', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and Bupropion.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8747', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-3.09', 'ciUpperLimit': '2.63', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and NRT patch.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6710', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-3.35', 'ciUpperLimit': '2.15', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9886', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-3.32', 'ciUpperLimit': '3.27', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Bupropion and NRT patch.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7631', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-2.92', 'ciUpperLimit': '2.14', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Bupropion and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8022', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-3.23', 'ciUpperLimit': '2.50', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between NRT patch and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.', 'description': 'This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.'}, {'type': 'SECONDARY', 'title': 'Incidence of MACE Assessed Until End of Study NCT01574703.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2016', 'groupId': 'OG000'}, {'value': '2006', 'groupId': 'OG001'}, {'value': '2022', 'groupId': 'OG002'}, {'value': '2014', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG001', 'title': 'Bupropion', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG002', 'title': 'NRT Patch', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000'}, {'value': '0.45', 'groupId': 'OG001'}, {'value': '0.30', 'groupId': 'OG002'}, {'value': '0.40', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6441', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '2.96', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and Bupropion.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7327', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-4.63', 'ciUpperLimit': '3.26', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and NRT patch.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6109', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.99', 'ciLowerLimit': '-4.80', 'ciUpperLimit': '2.82', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8707', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-2.48', 'ciUpperLimit': '2.93', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Bupropion and NRT patch.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9531', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-2.63', 'ciUpperLimit': '2.48', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Bupropion and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8262', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-2.99', 'ciUpperLimit': '2.39', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between NRT patch and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).', 'description': 'This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.'}, {'type': 'SECONDARY', 'title': 'Incidence of MACE+ Assessed Until End of Study NCT01574703.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2016', 'groupId': 'OG000'}, {'value': '2006', 'groupId': 'OG001'}, {'value': '2022', 'groupId': 'OG002'}, {'value': '2014', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG001', 'title': 'Bupropion', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG002', 'title': 'NRT Patch', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000'}, {'value': '0.75', 'groupId': 'OG001'}, {'value': '0.49', 'groupId': 'OG002'}, {'value': '0.60', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6105', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-2.84', 'ciUpperLimit': '1.67', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and Bupropion.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7895', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-2.65', 'ciUpperLimit': '2.01', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and NRT patch.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6804', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-2.75', 'ciUpperLimit': '1.80', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Varenicline and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8127', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-1.95', 'ciUpperLimit': '2.49', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Bupropion and NRT patch.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9218', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-2.04', 'ciUpperLimit': '2.25', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between Bupropion and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8841', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-2.32', 'ciUpperLimit': '2.00', 'pValueComment': 'P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.', 'groupDescription': 'Statistical analysis between NRT patch and Placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).', 'description': 'This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Varenicline', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.'}, {'id': 'FG001', 'title': 'Bupropion', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.'}, {'id': 'FG002', 'title': 'Nicotine Replacement Therapy (NRT) Patch', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1192'}, {'groupId': 'FG001', 'numSubjects': '1166'}, {'groupId': 'FG002', 'numSubjects': '1116'}, {'groupId': 'FG003', 'numSubjects': '1121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1067'}, {'groupId': 'FG001', 'numSubjects': '1054'}, {'groupId': 'FG002', 'numSubjects': '1011'}, {'groupId': 'FG003', 'numSubjects': '1007'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '112'}, {'groupId': 'FG002', 'numSubjects': '105'}, {'groupId': 'FG003', 'numSubjects': '114'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Unspecified Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '61'}]}, {'type': 'Met Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Of the 6293 participants who completed the parent study NCT01456936 as per protocol, a total of 4595 participants enrolled into this study NCT01574703 from 132 centers in 16 countries.', 'preAssignmentDetails': 'This is a non-treatment extension study of parent study NCT01456936. No study drug was provided in this extension phase. However, cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline(N=2016), bupropion(N=2006),NRT(N=2022), or placebo(N=2014) in a triple-dummy design were analyzed in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1192', 'groupId': 'BG000'}, {'value': '1166', 'groupId': 'BG001'}, {'value': '1116', 'groupId': 'BG002'}, {'value': '1121', 'groupId': 'BG003'}, {'value': '4595', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Varenicline', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.'}, {'id': 'BG001', 'title': 'Bupropion', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.'}, {'id': 'BG002', 'title': 'NRT Patch', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '47.7', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '48.3', 'spread': '11.9', 'groupId': 'BG002'}, {'value': '47.5', 'spread': '12.2', 'groupId': 'BG003'}, {'value': '47.9', 'spread': '12.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '659', 'groupId': 'BG000'}, {'value': '648', 'groupId': 'BG001'}, {'value': '623', 'groupId': 'BG002'}, {'value': '621', 'groupId': 'BG003'}, {'value': '2551', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '533', 'groupId': 'BG000'}, {'value': '518', 'groupId': 'BG001'}, {'value': '493', 'groupId': 'BG002'}, {'value': '500', 'groupId': 'BG003'}, {'value': '2044', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The term Baseline visit refers to the Baseline (Week 0) visit of the parent study NCT01456936. The safety population included all participants who received at least one dose of study drug in NCT01456936 parent study. The below Baseline characteristics (age, gender) are presented for all participants who entered study NCT01574703.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4595}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2012-04-06', 'resultsFirstSubmitDate': '2016-07-07', 'studyFirstSubmitQcDate': '2012-04-09', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-31', 'studyFirstPostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.', 'timeFrame': 'Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).', 'description': 'This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.'}], 'secondaryOutcomes': [{'measure': 'Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.', 'timeFrame': 'Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.', 'description': 'This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio.'}, {'measure': 'Time to MACE Until the End of Study NCT01574703.', 'timeFrame': 'Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).', 'description': 'This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio.'}, {'measure': 'Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.', 'timeFrame': 'Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).', 'description': 'This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug).'}, {'measure': 'Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.', 'timeFrame': 'Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).', 'description': 'This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.'}, {'measure': 'Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.', 'timeFrame': 'Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.', 'description': 'This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up.'}, {'measure': 'Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.', 'timeFrame': 'Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.', 'description': 'This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.'}, {'measure': 'Incidence of MACE Assessed Until End of Study NCT01574703.', 'timeFrame': 'Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).', 'description': 'This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study.'}, {'measure': 'Incidence of MACE+ Assessed Until End of Study NCT01574703.', 'timeFrame': 'Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).', 'description': 'This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['smoking cessation', 'psychiatric disease', 'cardiovascular events'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '29630702', 'type': 'DERIVED', 'citation': 'Benowitz NL, Pipe A, West R, Hays JT, Tonstad S, McRae T, Lawrence D, St Aubin L, Anthenelli RM. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):622-631. doi: 10.1001/jamainternmed.2018.0397.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051148&StudyName=Study%20To%20Evaluate%20Cardiac%20Assessments%20Following%20Different%20Treatments%20Of%20Smoking%20Cessation%20Medications%20In%20Subjects%20With%20And%20without%20Psychiatr', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.', 'detailedDescription': 'This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123. This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will be eligible if they were randomized to study A3051123.\n\nExclusion Criteria:\n\n* Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.'}, 'identificationModule': {'nctId': 'NCT01574703', 'acronym': 'CATS', 'briefTitle': 'Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders', 'orgStudyIdInfo': {'id': 'A3051148'}, 'secondaryIdInfos': [{'id': '2011-005513-37', 'type': 'EUDRACT_NUMBER'}, {'id': 'CATS', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'varenicline', 'interventionNames': ['Drug: varenicline tartrate']}, {'type': 'EXPERIMENTAL', 'label': 'bupropion', 'interventionNames': ['Drug: bupropion hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Nicotine Replacement Therapy Patch', 'interventionNames': ['Drug: Nicotine Replacement Therapy Patch']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'All dosing to have taken place per study A3051123', 'armGroupLabels': ['placebo']}, {'name': 'varenicline tartrate', 'type': 'DRUG', 'otherNames': ['Chantix; Champix'], 'description': 'All dosing to have taken place per study A3051123', 'armGroupLabels': 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