Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-01 @ 1:13 AM
Study NCT ID:
NCT00594204
Status:
COMPLETED
Last Update Posted:
2010-07-20
First Post:
2008-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Qatar']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@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 \\< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\< 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': {'eventGroups': [{'id': 'EG000', 'title': 'Varenicline', 'description': '0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks', 'otherNumAtRisk': 390, 'otherNumAffected': 224, 'seriousNumAtRisk': 390, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Placebo', 'description': 'matching placebo following the same treatment schema as the varenicline group', 'otherNumAtRisk': 198, 'otherNumAffected': 82, 'seriousNumAtRisk': 198, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Drug dependence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Appendicectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 390, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Participants With Continuous Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': '0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching placebo following the same treatment schema as the varenicline group'}], 'classes': [{'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '4.78', 'ciLowerLimit': '2.97', 'ciUpperLimit': '7.68', 'pValueComment': 'p-values are obtained from a logistic regression model including the main effects of treatment and country', 'estimateComment': 'Odds Ratios obtained from a logistic regression model including the main effects of treatment and country', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 9 through 24', 'description': 'The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO \\> 10 ppm', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Seven-day Point Prevalence of Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': '0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching placebo following the same treatment schema as the varenicline group'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '5.0', 'ciLowerLimit': '3.3', 'ciUpperLimit': '7.5', 'pValueComment': 'p-values obtained from a logistic regression model including the main effects of treatment and country', 'estimateComment': 'Odds ratios obtained from a logistic regression model including the main effects of treatment and country', 'groupDescription': 'Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '2.8', 'ciUpperLimit': '6.5', 'pValueComment': 'p-values obtained from a logistic regression model including the main effects of treatment and country', 'estimateComment': 'Odds ratios obtained from a logistic regression model including the main effects of treatment and country', 'groupDescription': 'Week 24', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12 and 24', 'description': 'Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO \\>10 ppm on that day', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Number of Participants With 4-week Continuous Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': '0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matching placebo following the same treatment schema as the varenicline group'}], 'classes': [{'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '5.76', 'ciLowerLimit': '3.74', 'ciUpperLimit': '8.88', 'estimateComment': 'Odds Ratios obtained from a logistic regression model including the main effects of treatment and country', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value are obtained from a logistic regression model including the main effects of treatment and country', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 9 through 12', 'description': 'The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \\> 10 parts per milion (ppm) at any of these visits', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Varenicline', 'description': '0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'matching placebo following the same treatment schema as the varenicline group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '394'}, {'groupId': 'FG001', 'numSubjects': '199'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '390'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '336'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '588', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Varenicline', 'description': '0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'matching placebo following the same treatment schema as the varenicline group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 55', 'categories': [{'measurements': [{'value': '334', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '498', 'groupId': 'BG002'}]}]}, {'title': '55 - 65', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': '> 65', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}]}], 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study contact(on the Nicotine Use Inventory) and who did not have CO \\> 10 ppm'}, {'measure': 'Number of Participants With Seven-day Point Prevalence of Abstinence', 'timeFrame': 'Week 12 and 24', 'description': 'Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO \\>10 ppm on that day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '37142273', 'type': 'DERIVED', 'citation': 'Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.'}, {'pmid': '21635992', 'type': 'DERIVED', 'citation': 'Bolliger CT, Issa JS, Posadas-Valay R, Safwat T, Abreu P, Correia EA, Park PW, Chopra P. Effects of varenicline in adult smokers: a multinational, 24-week, randomized, double-blind, placebo-controlled study. Clin Ther. 2011 Apr;33(4):465-77. doi: 10.1016/j.clinthera.2011.04.013.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051080&StudyName=Assessment%20of%20safety%20and%20efficacy%20of%20varenicline%20in%20patients%20that%20wish%20to%20stop%20smoking%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. 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