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To evaluate safety and efficacy of CE/BZA in real practice in Korea
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. 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; medically important events. AEs included both serious and all non-serious adverse events. | Baseline up to 28 days after last dose of study drug (up to 22 months) |
| Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. A treatment-related adverse event was any untoward medical occurrence attributed to Duavive tablet in a participant who received Duavive tablet. 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; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Duavive tablet was assessed by the investigator. | Baseline up to 28 days after last dose of study drug (up to 22 months) |
| Number of Participants Classified According to Measures Taken for Adverse Events | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Following measures were taken for AEs in relation to Duavive tablet: no change in treatment, permanently discontinued treatment and temporarily discontinued treatment. | Baseline up to 28 days after last dose of study drug (up to 22 months) |
| Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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General hospital and Primary clinic in Korea
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University/Department of Internal Medicine (Cardiology) | Jung-gu | Daegu | 700-721 | South Korea | ||
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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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In this study no screening was performed. Women participants who were administered Duavive tablet were enrolled.
This observational study was conducted in Korea. Enrolled participants included were administered with Duavive tablet 0.45 milligram (mg)/20 mg (conjugated estrogens 0.45 mg, bazedoxifene acetate 20 mg) for the first time as a part of routine treatment after the start of the study at a study site and complied with the local labeling. Participants were planned to be evaluated for 3 months, 6 months or more depending upon till when Duavive tablet was administered based on investigator's judgement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Duavive | Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Mar 24, 2020 | Jul 13, 2021 |
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Change from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved and as "Ineffectiveness" when there was no change in symptoms or symptoms aggravated. |
| Baseline, Month 3 |
| Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6 | Change from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved and as "Ineffectiveness" when there was no change in symptoms or symptoms aggravated. | Baseline, Month 6 |
| Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit | Improvement from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved. | Baseline, Last visit (last visit was anytime up to a maximum of Month 21) |
| Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 3 | Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported. | Month 3 |
| Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 6 | Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported. | Month 6 |
| Percentage of Participants With Prevention of Post-menopausal Osteoporosis at Last Visit | Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported. | Last visit (last visit was anytime up to a maximum of Month 21) |
| Dr. Wang's OB & GY Clinic |
| Seoul |
| Dobong-gu |
| 01432 |
| South Korea |
| Kimhyeonmi OBGY | Hwaseong-si | Dongtan | 18442 | South Korea |
| Korea University Ansan Hospital | Ansan | Gyeonggi-do | 425-707 | South Korea |
| Bucheon St. Mary Hospital The Catholic University of Korea | Bucheon-si | Gyeonggi-do | 14647 | South Korea |
| Baylor Ewha Obgyn Clinic | Seongnam-si | Gyeonggi-do | 463-811 | South Korea |
| Dongguk University Ilsan Medical Center Obstetrics | Goyang-si | Ilsandong-gu | 10326 | South Korea |
| Obstetrics / Grace Women's Hospital | Goyong-si | Ilsandong-gu | 10447 | South Korea |
| Kyungpook National University Hospital, Obstetrics | Daegu | Jung-gu | 41940 | South Korea |
| Pusan University Hospital Obstetrics | Pusan | Seo-gu | 602 739 | South Korea |
| Catholic Universith of Korea, Seoul ST. Mary's Hospital | Seoul | Seocho-gu | 06591 | South Korea |
| Samsung Medical Center, Sungkyunkwan Univ. School of Medicine | Kangnam-ku | Seoul | 135-710 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Seoul National University Hospital / Department of Internal Medicine | Seoul | 110-744 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 120-752 | South Korea |
| Asan Medical Center | Seoul | 138 736 | South Korea |
| Sanggye Paik Hospital-Inje University | Seoul | 139-707 | South Korea |
| Konkuk University Medical Center | Seoul | 143-729 | South Korea |
| Chungang University Hospital | Seoul | 156-755 | South Korea |
| AJOU University Hospital | Suwon | 443-380 | South Korea |
| Safety Analysis Set |
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| Efficacy Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Duavive | Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | 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 Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. 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; medically important events. AEs included both serious and all non-serious adverse events. | Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed follow up. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study drug (up to 22 months) |
|
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| Primary | Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. A treatment-related adverse event was any untoward medical occurrence attributed to Duavive tablet in a participant who received Duavive tablet. 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; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Duavive tablet was assessed by the investigator. | Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed follow up. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study drug (up to 22 months) |
|
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| Primary | Number of Participants Classified According to Measures Taken for Adverse Events | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Following measures were taken for AEs in relation to Duavive tablet: no change in treatment, permanently discontinued treatment and temporarily discontinued treatment. | Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed follow up. Here, "Overall Number of Participants Analyzed" signifies number of participants with adverse events. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study drug (up to 22 months) |
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| Primary | Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3 | Change from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved and as "Ineffectiveness" when there was no change in symptoms or symptoms aggravated. | Efficacy analysis set (EAS) of treatment for moderate to severe vasomotor symptoms associated with menopause included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for treatment of moderate to severe vasomotor symptoms associated with menopause. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure at Month 3. | Posted | Count of Participants | Participants | Baseline, Month 3 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6 | Change from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved and as "Ineffectiveness" when there was no change in symptoms or symptoms aggravated. | EAS of treatment for moderate to severe vasomotor symptoms associated with menopause included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for treatment of moderate to severe vasomotor symptoms associated with menopause. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure at Month 6. | Posted | Count of Participants | Participants | Baseline, Month 6 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit | Improvement from baseline in moderate to severe vasomotor symptoms associated with menopause was judged by investigator based on recorded symptoms and classified as "Effectiveness" when symptoms improved. | EAS of treatment for moderate to severe vasomotor symptoms associated with menopause included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for treatment of moderate to severe vasomotor symptoms associated with menopause. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Last visit (last visit was anytime up to a maximum of Month 21) |
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 3 | Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported. | EAS of prevention of postmenopausal osteoporosis included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for prevention of post-menopausal osteoporosis. | Posted | Count of Participants | Participants | Month 3 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 6 | Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported. | EAS of prevention of postmenopausal osteoporosis included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for prevention of post-menopausal osteoporosis. Here, "Overall number of participants analyzed" = participants who were administered with Duavive tablet for prevention of postmenopausal osteoporosis at Month 6. | Posted | Count of Participants | Participants | Month 6 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Prevention of Post-menopausal Osteoporosis at Last Visit | Investigator evaluated preventive effect of Duavive treatment based on comparing results of following at baseline and specified visit: X-ray examination, bone density test record, other blood test record related to resorption of bone and osteogenesis. In this outcome measure, data of only those participants in which Duavive treatment was effective in prevention of post-menopausal osteoporosis is reported. | EAS of prevention of postmenopausal osteoporosis included those participants who were administered with Duavive tablet at least once and completed follow up and were evaluated for prevention of post-menopausal osteoporosis. | Posted | Number | 95% Confidence Interval | percentage of participants | Last visit (last visit was anytime up to a maximum of Month 21) |
|
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Baseline up to 28 days after last dose of study drug (up to 22 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.
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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 | Duavive | Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document. | 0 | 639 | 2 | 639 | 71 | 639 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meniere's disease | Ear and labyrinth disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Gastric disorder | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Drug ineffective | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Face oedema | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Genital herpes | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Chondromalacia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Restless legs syndrome | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Mood altered | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Skin atrophy | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
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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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 21, 2020 | Jul 13, 2021 | SAP_001.pdf |
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