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In this survey, to collect the safety and efficacy information of Bazedoxifene in daily medical practice will be examined. In addition, the necessity of special Investigation and post-marketing clinical studies will be examined, while investigating unexpected adverse drug reactions during the survey period and understanding of the status of frequency of adverse drug reactions in daily medical practice.
All the subjects whom an investigator prescribes the first Bazedoxifene (Viviant) Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bazedoxifene Tablets | Subjects taking Bazedoxifene Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bazedoxifene | Drug | For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Viviant was assessed by the physician. | 3 years |
| Number of Participants With Any Fracture | Occurrence of any fracture after Viviant administration was examined to evaluate effectiveness of Viviant. The event of fracture was defined as an event which included "fracture" in Preferred Term (PT) or Lowest Level Term (LLT) of the MedDRA/J version 18.1. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Viviant was assessed by the physician. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects whom an investigator involving B1781007 prescribes the Bazedoxifene Tablets.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Viviant (Bazedoxifene Acetate) | Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Viviant (Bazedoxifene Acetate) | Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion. |
| 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 | Number of Participants With Treatment-Related Adverse Events | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Viviant was assessed by the physician. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once. | Posted | Count of Participants | Participants | 3 years |
|
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The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both serious and nonserious events 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 | Viviant (Bazedoxifene Acetate) | Participants who received Viviant as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biliary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
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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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| ID | Term |
|---|---|
| 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 |
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| Number of Participants With Treatment-Related Adverse Events by Age | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events. | 3 years |
| Number of Participants With Treatment-Related Adverse Events by Smoking Status | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment related-adverse events were counted by smoking status to assess whether it was a risk factor for the occurrence of treatment-related adverse events. | 3 years |
| Number of Participants With Treatment-Related Adverse Events by Use of Steroid | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of steroid to assess whether it was a risk factor for the occurrence of treatment-related adverse events. | 3 years |
| Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of previous medications to assess whether they were risk factors for the occurrence of treatment-related adverse events. | 3 years |
| Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use concomitant medications to assess whether they were risk factors for the occurrence of treatment-related adverse events. | 3 years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Smoking Status | Count of Participants | Participants |
|
| Use of Steroid | Count of Participants | Participants |
|
| Use of Previous Medication | Count of Participants | Participants |
|
| Use of Concomitant Medication | Count of Participants | Participants |
|
| Fracture History | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Viviant was assessed by the physician. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once. | Posted | Number | Participants | 3 years |
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events by Age | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once. | Posted | Number | Participants | 3 years |
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events by Smoking Status | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment related-adverse events were counted by smoking status to assess whether it was a risk factor for the occurrence of treatment-related adverse events. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once. | Posted | Number | Participants | 3 years |
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events by Use of Steroid | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of steroid to assess whether it was a risk factor for the occurrence of treatment-related adverse events. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once. | Posted | Number | Participants | 3 years |
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of previous medications to assess whether they were risk factors for the occurrence of treatment-related adverse events. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once. | Posted | Number | Participants | 3 years |
|
|
|
| Primary | Number of Participants With Any Fracture | Occurrence of any fracture after Viviant administration was examined to evaluate effectiveness of Viviant. The event of fracture was defined as an event which included "fracture" in Preferred Term (PT) or Lowest Level Term (LLT) of the MedDRA/J version 18.1. | The effectiveness analysis set was identical with the safety analysis set which comprised of participants who satisfied the inclusion criteria and had received Viviant at least once. | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication | A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use concomitant medications to assess whether they were risk factors for the occurrence of treatment-related adverse events. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once. | Posted | Number | Participants | 3 years |
|
|
|
| 95 |
| 3,034 |
| 83 |
| 3,034 |
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Neoplasm recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Ureteric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Anorectal disorder | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Autoimmune pancreatitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Disease progression | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
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 |
| ≥65 years |
|
|
|
| Unknown |
|
|
|
| Unknown |
|
|
|
| Unknown |
|
|
|