Post Marketing Surveillance For General Drug Use To Assess The Safety And Efficacy Profile Of Viviant In Usual Practice.
Overview
- Phase
- Not Applicable
- Intervention
- Viviant
- Conditions
- Osteoporosis
- Sponsor
- Pfizer
- Enrollment
- 3430
- Locations
- 60
- Primary Endpoint
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
Detailed Description
continuous enrollment
Investigators
Eligibility Criteria
Inclusion Criteria
- •Postmenopausal osteoporosis and osteopenia patients
Exclusion Criteria
- •Patients with active or past history of venous thromboembolic events including deep vein thrombosis,
- •Patients with pulmonary embolism and retinal vein thrombosis
Arms & Interventions
Viviant treatment group
Viviant treatment group
Intervention: Viviant
Outcomes
Primary Outcomes
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)
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.
Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs
Time Frame: Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)
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.
Secondary Outcomes
- Overall Efficacy Evaluation of Viviant 20 mg Tablet(Baseline up to 3 months)
- Number of Participants With Osteoporosis Related Fractures(Baseline up to 3 months)
- Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA)(Baseline up to 3 months)
- Number of Participants With Abnormal X-ray Result(Baseline up to 3 months)
- Number of Participants With Abnormal Bone Mineral Density Result(Baseline up to 3 months)
- Number of Participants With Abnormal Biochemical Markers of Bone Turnover(Baseline up to 3 months)