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This survey is conducted for preparing application material for re examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and efficacy profiles of VIVIANT in usual practice according to the Re-examination Regulation for New Drugs
continuous enrollment
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viviant treatment group | Viviant treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viviant | Drug | Viviant (Bazedoxifene) 20mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of Viviant 20 mg tablet, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. | Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months) |
| Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. Treatment related ADRs included all ADRs with causality related to treatment as judged by the investigator. | Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Efficacy Evaluation of Viviant 20 mg Tablet | Efficacy evaluation of Viviant 20 mg tablet was carried out on the basis of the assessment of clinical response by the treating physician. Clinical response among participants were assessed by the physician as improved, no change, worsened and unevaluable for efficacy. | Baseline up to 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Postmenopausal osteoporosis and osteopenia patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Haeundae Paik Hospital | Haeundae-gu | Busan | 48108 | South Korea | ||
| The Catholic University of Korea, Seoul St.Mary's Hospital |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Viviant Tablet 20 mg | Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2016 |
Not provided
Not provided
Not provided
| Number of Participants With Osteoporosis Related Fractures | Baseline up to 3 months |
| Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA) | DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion. | Baseline up to 3 months |
| Number of Participants With Abnormal X-ray Result | Criteria for abnormality was based on investigator's discretion. | Baseline up to 3 months |
| Number of Participants With Abnormal Bone Mineral Density Result | A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion. | Baseline up to 3 months |
| Number of Participants With Abnormal Biochemical Markers of Bone Turnover | In this study biochemical markers of bone turnover included C-telopeptide of collagen cross links (CTX), osteocalcin and bone specific alkaline phosphatase. Criteria for abnormality was based on investigator's discretion. | Baseline up to 3 months |
| Seoul |
| Capital Metropolitan |
| 06591 |
| South Korea |
| Dankook University Hospital | Cheonan-si | Chuncheongnam-do | 31116 | South Korea |
| Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | 26426 | South Korea |
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | 14068 | South Korea |
| Soon Chun Hyang University Bucheon Hospital | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
| Sejong Hospital | Bucheon-si | Gyeonggi-do | 422-807 | South Korea |
| Dongguk University Ilsan Hospital | Goyang-si | Gyeonggi-do | 10326 | South Korea |
| Inje University Ilsanpaik Hospital | Goyang-si | Gyeonggi-do | 10380 | South Korea |
| National Health Insurance Corporation Ilsan Hospital | Goyang-si | Gyeonggi-do | 10444 | South Korea |
| Myongji Hospital | Goyang-si | Gyeonggi-do | 10475 | South Korea |
| Il-San Gaspel Hospital | Goyang-si | Gyeonggi-do | 410-831 | South Korea |
| Inje University Ilsan Paik Hospital | Goyang-si | Gyeonggi-do | 411-706 | South Korea |
| Wonkwang University Sanbon Hospital | Gunpo | Gyeonggi-do | 15865 | South Korea |
| Hanyang University Guri Hospital | Guri-si | Gyeonggi-do | 11923 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| St. Vincent's Hospital-The Catholic University of Korea | Suwon | Gyeonggi-do | 16247 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Dongguk University Gyeongju Hospital | Gyeongju | Gyeongsangbuk-do | 780-350 | South Korea |
| Gyeongsang National University Hospital | Jinju | Gyeongsangnam-do | 52727 | South Korea |
| Yangsan Hospital-Pusan National University | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Wonkwang University Hospital | Iksan-si | Jeollabuk-do | 54538 | South Korea |
| Soon Chun Hyang University Hospital Seoul | Seoul | Korea | 04401 | South Korea |
| Eulji University Hospital | Daejeon | Republic of Korea | 35233 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | Seodaemun-gu | 03722 | South Korea |
| Hanyang University Medical Center | Seongdong-ku | Seoul | 133-792 | South Korea |
| Sung Mo O.S | Taebang-dong | Seoul | 156-808 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Dongrae Bongseng Hospital | Busan | 607-712 | South Korea |
| Centum Hospital | Busan | 613-812 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 41931 | South Korea |
| Kyungpook National Univ. Hospital | Daegu | 700-721 | South Korea |
| Daejeon St. Mary's Hospital-The Catholic University of Korea | Daejeon | 34943 | South Korea |
| Chungnam National University Hospital (CNUH) | Daejeon | 35015 | South Korea |
| Wonju Severance Christian Hospital | Gangwon-do | 220-701 | South Korea |
| Hosan OS Clinic | Goyang-si | 412-821 | South Korea |
| Gwangju Veterans Hosptial | Gwangju | 62284 | South Korea |
| Donguk University Gyeongju Hospital | Gyoungju | 780-350 | South Korea |
| Gachon University Gil Hospital | Incheon | 21565 | South Korea |
| Christian Internal Medicine Clinic | Incheon | 22104 | South Korea |
| Inje University Sanggye Paik Hospital | Seoul | 01757 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yeonsei University Health System | Seoul | 03722 | South Korea |
| Severance Hospital-Yonsei University College of Medicine | Seoul | 03722 | South Korea |
| Cheil General Hospital & Women's Healthcare Center | Seoul | 04619 | South Korea |
| Hanyang University Seoul Hospital | Seoul | 04763 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Asan Medical Center-University of Ulsan College of Medicine | Seoul | 05505 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Seoul St. Mary Hospital, The Catholic University of Korea | Seoul | 06591 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 07061 | South Korea |
| Choongmu Hospital | Seoul | 07301 | South Korea |
| Seoul Medical Center | Seoul | 131-865 | South Korea |
| Kwangmyeong Sungae Hospital | Seoul | 14241 | South Korea |
| Hongik Hospital | Seoul | South Korea |
| Jung Dong Hospital | Seoul | South Korea |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Viviant Tablet 20 mg | Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| 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 |
| |||||||||||||||||
| Weight Continuous | Mean | Standard Deviation | kilograms |
| |||||||||||||||||
| Height Continuous | Mean | Standard Deviation | centimeter |
|
| 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-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of Viviant 20 mg tablet, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. | Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up. | Posted | Count of Participants | Participants | Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months) |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Efficacy Evaluation of Viviant 20 mg Tablet | Efficacy evaluation of Viviant 20 mg tablet was carried out on the basis of the assessment of clinical response by the treating physician. Clinical response among participants were assessed by the physician as improved, no change, worsened and unevaluable for efficacy. | Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. | Posted | Count of Participants | Participants | Baseline up to 3 months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Osteoporosis Related Fractures | Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. | Posted | Count of Participants | Participants | Baseline up to 3 months |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA) | DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion. | Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. Here, "N (number of participants analyzed)" signifies number of participants analyzed for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to 3 months |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. Treatment related ADRs included all ADRs with causality related to treatment as judged by the investigator. | Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal X-ray Result | Criteria for abnormality was based on investigator's discretion. | Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. Here, "N" signifies number of participants analyzed for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to 3 months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Bone Mineral Density Result | A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion. | Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. Here, "N" signifies number of participants analyzed for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to 3 months |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Biochemical Markers of Bone Turnover | In this study biochemical markers of bone turnover included C-telopeptide of collagen cross links (CTX), osteocalcin and bone specific alkaline phosphatase. Criteria for abnormality was based on investigator's discretion. | Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. Here, "n (number analyzed)" signifies the number of participants with available data for each category. | Posted | Count of Participants | Participants | Baseline up to 3 months |
|
|
Baseline up to 28 days after last dose of Viviant 20 mg tablet (up to 6 months)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Viviant Tablet 20 mg | Participants who received Viviant tablet 20 milligram (mg) once daily orally as a part of routine clinical practice for the first time, were observed for up to a maximum of 6 months. The dose and frequency of Viviant tablet was according to the treating physician as per the approved product labelling. | 1 | 3,423 | 17 | 3,423 | 192 | 3,423 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SPINAL STENOSIS | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| DEATH | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| FEVER | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| OEDEMA GENERALISED | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
| |
| FRACTURE | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| ROTARY CUFF SYNDROME | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| RESPIRATORY INSUFFICIENCY | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Vascular disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| CEREBRAL INFARCTION | Vascular disorders | WHO-ART 092 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INSOMNIA | Psychiatric disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| CRAMPS LEGS | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| DIZZINESS POSTURAL | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| SPINAL STENOSIS | Nervous system disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| PALPITATION | Cardiac disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| EYE PAIN | Eye disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| RETINAL HAEMORRHAGE | Eye disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| VISION ABNORMAL | Eye disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| COLONIC POLYP | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| ERUCTATION | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| MOUTH DRY | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| ALLERGIC REACTION | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| EFFECT, LACK OF | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| FACE OEDEMA | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| FEVER | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| LEG PAIN | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| MALAISE | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| OEDEMA | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| OEDEMA GENERALISED | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| OEDEMA PERIORBITAL | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| TEMPERATURE CHANGED SENSATION | General disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| HEPATIC CYST | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| HEPATOCELLULAR DAMAGE | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| PHOSPHATASE ALKALINE INCREASED | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| SGOT INCREASED | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| SGPT INCREASED | Hepatobiliary disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
| |
| CYSTITIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | WHO-ART 092 | Non-systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | WHO-ART 092 | Non-systematic Assessment |
| |
| HYPERLIPAEMIA | Metabolism and nutrition disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| OBESITY CENTRAL | Metabolism and nutrition disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| WEIGHT INCREASE | Metabolism and nutrition disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| FRACTURE | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| RENAL CYST | Renal and urinary disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| URINE ABNORMAL | Renal and urinary disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| BREAST ENGORGEMENT | Reproductive system and breast disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| VAGINAL HAEMORRHAGE | Reproductive system and breast disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| COUGHING | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| LARYNGITIS | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| SPUTUM DISORDER | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| SKIN REACTION LOCALISED | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| SWEATING INCREASED | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
| |
| FLUSHING | Vascular disorders | WHO-ART 092 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| May 31, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C447119 | bazedoxifene |
Not provided
Not provided
Not provided
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|