Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT01416194
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2011-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C447119', 'term': 'bazedoxifene'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D020849', 'term': 'Raloxifene Hydrochloride'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, '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': 'Not applicable as safety data was not planned to be collected during the study', 'description': 'Safety data was not planned to be collected during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Incidence of Venous Thromboembolism (VTE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.4'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '2.8'}, {'value': '4.6', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '5.1'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.3', 'ciUpperLimit': '0.7', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.4', 'ciUpperLimit': '2.2', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'VTE is defined as deep vein thrombosis (DVT), pulmonary embolism (PE), retinal vein thrombosis, and sinus thrombosis. DVT: occurs when a blood clot forms in a vein located deep inside the body. PE: a blockage of an artery in the lungs by a substance that has moved from elsewhere in the body through the bloodstream (embolism). Sinus thrombosis: presence of a blood clot in the dural venous sinuses, which drain blood from the brain. Retinal vein thrombosis: blockage of the small veins that carry blood away from the retina. Cumulative incidence was calculated as total participants with VTE events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Ischemic Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '3.2'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.3'}, {'value': '6.7', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '7.4'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.3', 'ciUpperLimit': '0.7', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.5', 'ciUpperLimit': '2.4', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Ischemic stroke is caused by a blockage in an artery that supplies blood to the brain. Cumulative incidence was calculated as total participants with ischemic stroke events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Cardiac Disorders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.0'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '3.7'}, {'value': '6.6', 'groupId': 'OG002', 'lowerLimit': '6.1', 'upperLimit': '7.3'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.3', 'ciUpperLimit': '0.9', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.4', 'ciUpperLimit': '1.5', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Cardiac disorders included myocardial infarction, myocardial ischemia, and coronary occlusion. Cumulative incidence was calculated as total participants with cardiac disorders events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '3.9'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '5.1'}, {'value': '6.5', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': '7.2'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.1', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.4', 'ciUpperLimit': '1.2', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Atrial fibrillation is an irregular heartbeat that increases the risk of stroke and heart disease. Cumulative incidence was calculated as total participants with atrial fibrillation events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Biliary Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '2.8'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.6'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '3.5', 'upperLimit': '4.5'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.3', 'ciUpperLimit': '0.7', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.4', 'ciUpperLimit': '2.1', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Biliary events included cholecystitis and cholelithiasis. Cumulative incidence was calculated as total participants with biliary events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Hypertriglyceridemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '11.6'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '11.8'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '5.4', 'upperLimit': '6.5'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '1.4', 'ciUpperLimit': '2.5', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.7', 'ciUpperLimit': '1.3', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Hypertriglyceridemia refers to high blood levels of triglycerides. Cumulative incidence was calculated as total participants with hypertriglyceridemia events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Clinical Fractures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '5.8'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '9.3'}, {'value': '12.8', 'groupId': 'OG002', 'lowerLimit': '12.0', 'upperLimit': '13.6'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.3', 'ciUpperLimit': '0.6', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.4', 'ciUpperLimit': '0.9', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'A fracture is a break in a bone. Cumulative incidence was calculated as total participants with clinical fractures events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Renal Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '1.5'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '3.0'}, {'value': '4.8', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '5.3'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.1', 'ciUpperLimit': '0.5', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '0.2', 'ciUpperLimit': '1.1', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Cumulative incidence was calculated as total participants with renal failure events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of All Malignancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '4.3'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '5.2'}, {'value': '6.6', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '7.2'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '0.3', 'ciUpperLimit': '0.7', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.4', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'All malignancies included and not limited only to thyroid, breast, renal, genital / urogenital, lung cancer, gastrointestinal tract and respiratory tract. Cumulative incidence was calculated as total participants with malignancies events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Different Types of Malignancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'classes': [{'title': 'Malignancies - Thyroid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.3'}, {'value': '0.2', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '0.3'}]}]}, {'title': 'Malignancies - Breast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.9'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '1.0'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '1.1', 'upperLimit': '1.7'}]}]}, {'title': 'Malignancies - Renal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.3'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.2'}]}]}, {'title': 'Malignancies - Genital / Urogenital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.2'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.7'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '0.7'}]}]}, {'title': 'Malignancies - Lung', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.8'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.7'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '0.5'}]}]}, {'title': 'Malignancies- Gastrointestinal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '1.9'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '1.6'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '1.8'}]}]}, {'title': 'Malignancies- Respiratory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'In this outcome measure, cumulative incidence of different types of malignancies included breast, renal, thyroid, genital / urogenital, gastrointestinal tract, lung and respiratory tract were calculated. Cumulative incidence for each type of malignancy was calculated as total participant with the respective malignancy events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence for each type of malignancy was expressed as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '12.0'}, {'value': '9.2', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '10.4'}, {'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '7.9', 'upperLimit': '9.3'}]}]}], 'analyses': [{'pValue': '0.24', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.5', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.6', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Cumulative incidence was calculated as total participants with depression events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Selected Ocular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '9.8'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '13.8'}, {'value': '10.8', 'groupId': 'OG002', 'lowerLimit': '10.1', 'upperLimit': '11.6'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.6', 'ciUpperLimit': '1.0', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.6', 'ciUpperLimit': '1.1', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Selected ocular events included retinal vascular occlusions, disorders of the globe, iris, ciliary body, retina, eye adnexa and cornea. Cumulative incidence was calculated as total participants with selected ocular events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Thyroid Disorders- Goitre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}, {'value': '2720', 'groupId': 'OG001'}, {'value': '6666', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG001', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'OG002', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '2.5'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '3.1'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '3.4', 'upperLimit': '4.3'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '0.2', 'ciUpperLimit': '0.5', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.24', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.3', 'ciUpperLimit': '1.3', 'groupDescription': 'The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Goitre is a swelling in the neck resulting from an enlarged thyroid gland. Cumulative incidence was calculated as total participants with thyroid disorders-goitre events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per summary of product characteristics (SmPC) and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'FG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'FG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1111'}, {'groupId': 'FG001', 'numSubjects': '2720'}, {'groupId': 'FG002', 'numSubjects': '6666'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1111'}, {'groupId': 'FG001', 'numSubjects': '2720'}, {'groupId': 'FG002', 'numSubjects': '6666'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This is a retrospective, observational, non-interventional study. Data was collected from proprietary longitudinal patient databases (LPD).', 'preAssignmentDetails': 'The index date for each participant was the date of first recorded prescription for bazedoxifene, raloxifene or bisphosphonate. Follow-up period was from index date to first incident of primary event or date of last contact, whichever occurred first. Follow-up was maximum up to approximately of 92.1 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'BG000'}, {'value': '2720', 'groupId': 'BG001'}, {'value': '6666', 'groupId': 'BG002'}, {'value': '10497', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Bazedoxifene', 'description': 'Participants with postmenopausal osteoporosis received bazedoxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'BG001', 'title': 'Raloxifene', 'description': 'Participants with postmenopausal osteoporosis received raloxifene in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'BG002', 'title': 'Bisphosphonate', 'description': 'Participants with postmenopausal osteoporosis received bisphosphonate in usual routine clinical care per SmPC and dose was adjusted by physicians solely according to medical and therapeutic necessity.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'BG000'}, {'value': '2720', 'groupId': 'BG001'}, {'value': '6666', 'groupId': 'BG002'}, {'value': '10497', 'groupId': 'BG003'}]}], 'categories': [{'title': 'From 45-49 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '217', 'groupId': 'BG003'}]}, {'title': 'From 50-59 years', 'measurements': [{'value': '479', 'groupId': 'BG000'}, {'value': '665', 'groupId': 'BG001'}, {'value': '915', 'groupId': 'BG002'}, {'value': '2059', 'groupId': 'BG003'}]}, {'title': 'From 60-69 years', 'measurements': [{'value': '382', 'groupId': 'BG000'}, {'value': '1229', 'groupId': 'BG001'}, {'value': '1915', 'groupId': 'BG002'}, {'value': '3526', 'groupId': 'BG003'}]}, {'title': 'From greater than equal to (>=) 70 years', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '3748', 'groupId': 'BG002'}, {'value': '4695', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'BG000'}, {'value': '2720', 'groupId': 'BG001'}, {'value': '6666', 'groupId': 'BG002'}, {'value': '10497', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1111', 'groupId': 'BG000'}, {'value': '2720', 'groupId': 'BG001'}, {'value': '6666', 'groupId': 'BG002'}, {'value': '10497', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-08-19', 'size': 944184, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-27T10:34', 'hasProtocol': True}, {'date': '2016-09-27', 'size': 587552, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-27T11:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10497}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2011-08-11', 'resultsFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2011-08-11', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-27', 'studyFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Incidence of Venous Thromboembolism (VTE)', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'VTE is defined as deep vein thrombosis (DVT), pulmonary embolism (PE), retinal vein thrombosis, and sinus thrombosis. DVT: occurs when a blood clot forms in a vein located deep inside the body. PE: a blockage of an artery in the lungs by a substance that has moved from elsewhere in the body through the bloodstream (embolism). Sinus thrombosis: presence of a blood clot in the dural venous sinuses, which drain blood from the brain. Retinal vein thrombosis: blockage of the small veins that carry blood away from the retina. Cumulative incidence was calculated as total participants with VTE events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.'}], 'secondaryOutcomes': [{'measure': 'Cumulative Incidence of Ischemic Stroke', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Ischemic stroke is caused by a blockage in an artery that supplies blood to the brain. Cumulative incidence was calculated as total participants with ischemic stroke events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.'}, {'measure': 'Cumulative Incidence of Cardiac Disorders', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Cardiac disorders included myocardial infarction, myocardial ischemia, and coronary occlusion. Cumulative incidence was calculated as total participants with cardiac disorders events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.'}, {'measure': 'Cumulative Incidence of Atrial Fibrillation', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Atrial fibrillation is an irregular heartbeat that increases the risk of stroke and heart disease. Cumulative incidence was calculated as total participants with atrial fibrillation events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.'}, {'measure': 'Cumulative Incidence of Biliary Events', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Biliary events included cholecystitis and cholelithiasis. Cumulative incidence was calculated as total participants with biliary events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.'}, {'measure': 'Cumulative Incidence of Hypertriglyceridemia', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Hypertriglyceridemia refers to high blood levels of triglycerides. Cumulative incidence was calculated as total participants with hypertriglyceridemia events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.'}, {'measure': 'Cumulative Incidence of Clinical Fractures', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'A fracture is a break in a bone. Cumulative incidence was calculated as total participants with clinical fractures events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.'}, {'measure': 'Cumulative Incidence of Renal Failure', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Cumulative incidence was calculated as total participants with renal failure events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.'}, {'measure': 'Cumulative Incidence of All Malignancies', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'All malignancies included and not limited only to thyroid, breast, renal, genital / urogenital, lung cancer, gastrointestinal tract and respiratory tract. Cumulative incidence was calculated as total participants with malignancies events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.'}, {'measure': 'Cumulative Incidence of Different Types of Malignancies', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'In this outcome measure, cumulative incidence of different types of malignancies included breast, renal, thyroid, genital / urogenital, gastrointestinal tract, lung and respiratory tract were calculated. Cumulative incidence for each type of malignancy was calculated as total participant with the respective malignancy events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence for each type of malignancy was expressed as percentage of participants.'}, {'measure': 'Cumulative Incidence of Depression', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Cumulative incidence was calculated as total participants with depression events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.'}, {'measure': 'Cumulative Incidence of Selected Ocular Events', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Selected ocular events included retinal vascular occlusions, disorders of the globe, iris, ciliary body, retina, eye adnexa and cornea. Cumulative incidence was calculated as total participants with selected ocular events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.'}, {'measure': 'Cumulative Incidence of Thyroid Disorders- Goitre', 'timeFrame': 'Up to a maximum of follow-up period of 92.1 months', 'description': 'Goitre is a swelling in the neck resulting from an enlarged thyroid gland. Cumulative incidence was calculated as total participants with thyroid disorders-goitre events during follow-up period divided by total persons at risk during follow-up period\\*100 and hence cumulative incidence was expressed as percentage of participants.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoporosis'], 'conditions': ['Osteoporosis, Postmenopausal']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1781044&StudyName=Bazedoxifene%20Post%20Approval%20Safety%20Study%20%28PASS%29%20in%20the%20European%20Union%20%28EU%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This observational cohort study is being conducted to further characterize selected adverse events of interest among a patient population with osteoporosis who are prescribed bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized clinical trial setting. The study will compare the rates of the selected clinical events among the three treatment groups.', 'detailedDescription': 'All women in the database meeting the inclusion criteria will be included in the study without any statistical sampling.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women aged 45 or over who have records of receiving bazedoxifene, bisphosphonates or raloxifene in the Cegedim database in Italy and Spain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* At least one prescription for bazedoxifene, raloxifene, or any bisphosphonate during the study inclusion period (index prescription);\n* A recoded diagnosis code of osteoporosis on or within 60 days prior to the index prescription date;\n* Age \\>=45 at the date of the index prescription; and\n* At least 6-months of follow-up data in the electronic medical record system prior to the date of the index prescription\n\nExclusion Criteria:\n\n* There is no exclusion criteria. All women in the database who meet the inclusion criteria will be studied.'}, 'identificationModule': {'nctId': 'NCT01416194', 'briefTitle': 'Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'COHORT STUDY OF VENOUS THROMBOEMBOLISM AND OTHER CLINICAL ENDPOINTS AMONG OSTEOPOROTIC WOMEN PRESCRIBED BAZEDOXIFENE, BISPHOSPHONATES OR RALOXIFENE IN EUROPE', 'orgStudyIdInfo': {'id': 'B1781044'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bazedoxifene', 'interventionNames': ['Drug: Bazedoxifene']}, {'label': 'Primary Comparator', 'interventionNames': ['Drug: Bisphosphonate']}, {'label': 'Secondary Comparator', 'interventionNames': ['Drug: Raloxifene']}], 'interventions': [{'name': 'Bazedoxifene', 'type': 'DRUG', 'description': 'Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.', 'armGroupLabels': ['Bazedoxifene']}, {'name': 'Bisphosphonate', 'type': 'DRUG', 'description': 'Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.', 'armGroupLabels': ['Primary Comparator']}, {'name': 'Raloxifene', 'type': 'DRUG', 'description': 'Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.', 'armGroupLabels': ['Secondary Comparator']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}