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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.
All women in the database meeting the inclusion criteria will be included in the study without any statistical sampling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bazedoxifene |
| ||
| Primary Comparator |
| ||
| Secondary Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bazedoxifene | Drug | Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Venous Thromboembolism (VTE) | 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. | Up to a maximum of follow-up period of 92.1 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Ischemic Stroke | 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. | Up to a maximum of follow-up period of 92.1 months |
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Inclusion Criteria:
Exclusion Criteria:
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Women aged 45 or over who have records of receiving bazedoxifene, bisphosphonates or raloxifene in the Cegedim database in Italy and Spain.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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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.
This is a retrospective, observational, non-interventional study. Data was collected from proprietary longitudinal patient databases (LPD).
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| ID | Title | Description |
|---|---|---|
| FG000 | Bazedoxifene | 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. |
| FG001 | Raloxifene | 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. |
| FG002 | Bisphosphonate | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bazedoxifene | 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. |
| BG001 | Raloxifene |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Incidence of Venous Thromboembolism (VTE) | 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. | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to a maximum of follow-up period of 92.1 months |
|
Not applicable as safety data was not planned to be collected during the study
Safety data was not planned to be collected during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bazedoxifene | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 19, 2013 | Apr 27, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2016 | Apr 27, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C447119 | bazedoxifene |
| D004164 | Diphosphonates |
| D020849 | Raloxifene Hydrochloride |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D013629 | Tamoxifen |
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| Bisphosphonate | Drug | Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule. |
|
| Raloxifene | Drug | Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule. |
|
| Cumulative Incidence of Cardiac Disorders | 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. | Up to a maximum of follow-up period of 92.1 months |
| Cumulative Incidence of Atrial Fibrillation | 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. | Up to a maximum of follow-up period of 92.1 months |
| Cumulative Incidence of Biliary Events | 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. | Up to a maximum of follow-up period of 92.1 months |
| Cumulative Incidence of Hypertriglyceridemia | 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. | Up to a maximum of follow-up period of 92.1 months |
| Cumulative Incidence of Clinical Fractures | 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. | Up to a maximum of follow-up period of 92.1 months |
| Cumulative Incidence of Renal Failure | 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. | Up to a maximum of follow-up period of 92.1 months |
| Cumulative Incidence of All Malignancies | 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. | Up to a maximum of follow-up period of 92.1 months |
| Cumulative Incidence of Different Types of Malignancies | 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. | Up to a maximum of follow-up period of 92.1 months |
| Cumulative Incidence of Depression | 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. | Up to a maximum of follow-up period of 92.1 months |
| Cumulative Incidence of Selected Ocular Events | 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. | Up to a maximum of follow-up period of 92.1 months |
| Cumulative Incidence of Thyroid Disorders- Goitre | 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. | Up to a maximum of follow-up period of 92.1 months |
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.
| BG002 | Bisphosphonate | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG000 |
| Bazedoxifene |
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. |
| OG001 | Raloxifene | 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. |
| OG002 | Bisphosphonate | 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. |
|
|
|
| Secondary | Cumulative Incidence of Ischemic Stroke | 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. | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to a maximum of follow-up period of 92.1 months |
|
|
|
|
| Secondary | Cumulative Incidence of Cardiac Disorders | 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. | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to a maximum of follow-up period of 92.1 months |
|
|
|
|
| Secondary | Cumulative Incidence of Atrial Fibrillation | 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. | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to a maximum of follow-up period of 92.1 months |
|
|
|
|
| Secondary | Cumulative Incidence of Biliary Events | 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. | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to a maximum of follow-up period of 92.1 months |
|
|
|
|
| Secondary | Cumulative Incidence of Hypertriglyceridemia | 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. | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to a maximum of follow-up period of 92.1 months |
|
|
|
|
| Secondary | Cumulative Incidence of Clinical Fractures | 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. | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to a maximum of follow-up period of 92.1 months |
|
|
|
|
| Secondary | Cumulative Incidence of Renal Failure | 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. | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to a maximum of follow-up period of 92.1 months |
|
|
|
|
| Secondary | Cumulative Incidence of All Malignancies | 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. | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to a maximum of follow-up period of 92.1 months |
|
|
|
|
| Secondary | Cumulative Incidence of Different Types of Malignancies | 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. | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to a maximum of follow-up period of 92.1 months |
|
|
|
| Secondary | Cumulative Incidence of Depression | 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. | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to a maximum of follow-up period of 92.1 months |
|
|
|
|
| Secondary | Cumulative Incidence of Selected Ocular Events | 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. | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to a maximum of follow-up period of 92.1 months |
|
|
|
|
| Secondary | Cumulative Incidence of Thyroid Disorders- Goitre | 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. | Full analysis set included all women participants in database who met the inclusion criteria and whose data was observed in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to a maximum of follow-up period of 92.1 months |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Raloxifene | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Bisphosphonate | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| D009750 |
| Nutritional and Metabolic Diseases |
| D013267 |
| Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| From 50-59 years |
|
| From 60-69 years |
|
| From greater than equal to (>=) 70 years |
|
| Male |
|
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. |
| Regression, Logistic |
| 0.76 |
| Hazard Ratio (HR) |
| 1.1 |
| 2-Sided |
| 95 |
| 0.5 |
| 2.4 |
| Superiority |
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. |
| Regression, Logistic |
| 0.37 |
| Hazard Ratio (HR) |
| 0.7 |
| 2-Sided |
| 95 |
| 0.4 |
| 1.5 |
| Superiority |
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. |
| Regression, Logistic |
| 0.19 |
| Hazard Ratio (HR) |
| 0.7 |
| 2-Sided |
| 95 |
| 0.4 |
| 1.2 |
| Superiority |
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. |
| Regression, Linear |
| 0.90 |
| Hazard Ratio (HR) |
| 1.0 |
| 2-Sided |
| 95 |
| 0.4 |
| 2.1 |
| Superiority |
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. |
| Regression, Logistic |
| 0.74 |
| Hazard Ratio (HR) |
| 0.9 |
| 2-Sided |
| 95 |
| 0.7 |
| 1.3 |
| Superiority |
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. |
| Regression, Logistic |
| 0.01 |
| Hazard Ratio (HR) |
| 0.6 |
| 2-Sided |
| 95 |
| 0.4 |
| 0.9 |
| Superiority |
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. |
| Regression, Linear |
| 0.06 |
| Hazard Ratio (HR) |
| 0.4 |
| 2-Sided |
| 95 |
| 0.2 |
| 1.1 |
| Superiority |
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. |
| Regression, Linear |
| 0.38 |
| Hazard Ratio (HR) |
| 0.8 |
| 2-Sided |
| 95 |
| 0.5 |
| 1.4 |
| Superiority |
| Malignancies - Breast |
|
|
| Malignancies - Renal |
|
|
| Malignancies - Genital / Urogenital |
|
|
| Malignancies - Lung |
|
|
| Malignancies- Gastrointestinal |
|
|
| Malignancies- Respiratory |
|
|
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. |
| Regression, Linear |
| 0.59 |
| Hazard Ratio (HR) |
| 1.1 |
| 2-Sided |
| 95 |
| 0.8 |
| 1.6 |
| Superiority |
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. |
| Regression, Linear |
| 0.19 |
| Hazard Ratio (HR) |
| 0.8 |
| 2-Sided |
| 95 |
| 0.6 |
| 1.1 |
| Superiority |
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. |
| Regression, Linear |
| 0.24 |
| Hazard Ratio (HR) |
| 0.6 |
| 2-Sided |
| 95 |
| 0.3 |
| 1.3 |
| Superiority |