Trial · NCT01416194
Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)
NCT01416194, Completed, Pfizer; results first posted 2020-05-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU). Trials, record NCT01416194. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01416194
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)
- NCT number
- NCT01416194
- Status
- Completed
- Enrollment
- 10,497 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Osteoporosis, Postmenopausal
- Interventions
- Bazedoxifene, Bisphosphonate, Raloxifene
- First posted
- 2011-08-12
- Last updated
- 2024-04-22
- Results first posted
- 2020-05-18
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Incidence of Venous Thromboembolism (VTE) | Up to a maximum of follow-up period of 92.1 months | 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. |
| Secondary | Cumulative Incidence of Ischemic Stroke | Up to a maximum of follow-up period of 92.1 months | 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. |
| Secondary | Cumulative Incidence of Cardiac Disorders | Up to a maximum of follow-up period of 92.1 months | 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. |
| Secondary | Cumulative Incidence of Atrial Fibrillation | Up to a maximum of follow-up period of 92.1 months | 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. |
| Secondary | Cumulative Incidence of Biliary Events | Up to a maximum of follow-up period of 92.1 months | 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. |
| Secondary | Cumulative Incidence of Hypertriglyceridemia | Up to a maximum of follow-up period of 92.1 months | 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. |
| Secondary | Cumulative Incidence of Clinical Fractures | Up to a maximum of follow-up period of 92.1 months | 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. |
| Secondary | Cumulative Incidence of Renal Failure | Up to a maximum of follow-up period of 92.1 months | 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. |
| Secondary | Cumulative Incidence of All Malignancies | Up to a maximum of follow-up period of 92.1 months | 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. |
| Secondary | Cumulative Incidence of Different Types of Malignancies | Up to a maximum of follow-up period of 92.1 months | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative Incidence of Venous Thromboembolism (VTE) | Up to a maximum of follow-up period of 92.1 months | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Ischemic Stroke | Up to a maximum of follow-up period of 92.1 months | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Cardiac Disorders | Up to a maximum of follow-up period of 92.1 months | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Atrial Fibrillation | Up to a maximum of follow-up period of 92.1 months | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Biliary Events | Up to a maximum of follow-up period of 92.1 months | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Hypertriglyceridemia | Up to a maximum of follow-up period of 92.1 months | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Clinical Fractures | Up to a maximum of follow-up period of 92.1 months | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Renal Failure | Up to a maximum of follow-up period of 92.1 months | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of All Malignancies | Up to a maximum of follow-up period of 92.1 months | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Incidence of Different Types of Malignancies | Up to a maximum of follow-up period of 92.1 months | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative Incidence of Venous Thromboembolism (VTE) | Bazedoxifene | 1.5 | 95% Confidence Interval 1.0 to 2.4 | percentage of participants | |
| Cumulative Incidence of Venous Thromboembolism (VTE) | Raloxifene | 2.2 | 95% Confidence Interval 1.7 to 2.8 | percentage of participants | |
| Cumulative Incidence of Venous Thromboembolism (VTE) | Bisphosphonate | 4.6 | 95% Confidence Interval 4.1 to 5.1 | percentage of participants | |
| Cumulative Incidence of Ischemic Stroke | Bazedoxifene | 2.2 | 95% Confidence Interval 1.5 to 3.2 | percentage of participants | |
| Cumulative Incidence of Ischemic Stroke | Raloxifene | 2.6 | 95% Confidence Interval 2.1 to 3.3 | percentage of participants | |
| Cumulative Incidence of Ischemic Stroke | Bisphosphonate | 6.7 | 95% Confidence Interval 6.2 to 7.4 | percentage of participants | |
| Cumulative Incidence of Cardiac Disorders | Bazedoxifene | 2 | 95% Confidence Interval 1.3 to 3.0 | percentage of participants | |
| Cumulative Incidence of Cardiac Disorders | Raloxifene | 3 | 95% Confidence Interval 2.4 to 3.7 | percentage of participants | |
| Cumulative Incidence of Cardiac Disorders | Bisphosphonate | 6.6 | 95% Confidence Interval 6.1 to 7.3 | percentage of participants | |
| Cumulative Incidence of Atrial Fibrillation | Bazedoxifene | 2.8 | 95% Confidence Interval 2.0 to 3.9 | percentage of participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bazedoxifene | 1,111 | |
| Overall Study | STARTED | Raloxifene | 2,720 | |
| Overall Study | STARTED | Bisphosphonate | 6,666 | |
| Overall Study | COMPLETED | Bazedoxifene | 1,111 | |
| Overall Study | COMPLETED | Raloxifene | 2,720 | |
| Overall Study | COMPLETED | Bisphosphonate | 6,666 | |
| Overall Study | NOT COMPLETED | Bazedoxifene | 0 | |
| Overall Study | NOT COMPLETED | Raloxifene | 0 | |
| Overall Study | NOT COMPLETED | Bisphosphonate | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bazedoxifene | 0 | 0 |
| Total, all-cause mortality | Raloxifene | 0 | 0 |
| Total, all-cause mortality | Bisphosphonate | 0 | 0 |
| Total, other adverse events | Bazedoxifene | 0 | 0 |
| Total, other adverse events | Raloxifene | 0 | 0 |
| Total, other adverse events | Bisphosphonate | 0 | 0 |
| Total, serious adverse events | Bazedoxifene | 0 | 0 |
| Total, serious adverse events | Raloxifene | 0 | 0 |
| Total, serious adverse events | Bisphosphonate | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01416194
GET https://conductscience.org/api/trials/v1/NCT01416194/results?page=2