Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-03-11 @ 2:50 PM
Study NCT ID:
NCT02792504
Status:
COMPLETED
Last Update Posted:
2021-08-05
First Post:
2016-02-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 28 days after last dose of study drug (up to 22 months)', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Duavive', 'description': 'Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.', 'otherNumAtRisk': 639, 'deathsNumAtRisk': 639, 'otherNumAffected': 71, 'seriousNumAtRisk': 639, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastric disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chondromalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vulvovaginal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': "Meniere's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 639, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duavive', 'description': 'Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 28 days after last dose of study drug (up to 22 months)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed follow up.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duavive', 'description': 'Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'title': 'Treatment Related AEs', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 28 days after last dose of study drug (up to 22 months)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed follow up.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Classified According to Measures Taken for Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duavive', 'description': 'Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'title': 'No change in treatment', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Permanently discontinued treatment', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Temporarily discontinued treatment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 28 days after last dose of study drug (up to 22 months)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '387', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duavive', 'description': 'Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'title': 'Effectiveness', 'categories': [{'measurements': [{'value': '319', 'groupId': 'OG000'}]}]}, {'title': 'Ineffectiveness', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Month 3', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duavive', 'description': 'Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'title': 'Effectiveness', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}, {'title': 'Ineffectiveness', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Month 6', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duavive', 'description': 'Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.31', 'groupId': 'OG000', 'lowerLimit': '78.15', 'upperLimit': '85.97'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Last visit (last visit was anytime up to a maximum of Month 21)', 'description': '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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duavive', 'description': 'Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 3', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duavive', 'description': 'Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 6', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Prevention of Post-menopausal Osteoporosis at Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Duavive', 'description': 'Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.27', 'groupId': 'OG000', 'lowerLimit': '54.63', 'upperLimit': '92.18'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Last visit (last visit was anytime up to a maximum of Month 21)', 'description': '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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Duavive', 'description': 'Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '669'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '639'}]}, {'type': 'Efficacy Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '390'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '639'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Violated inclusion/exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': "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.", 'preAssignmentDetails': 'In this study no screening was performed. Women participants who were administered Duavive tablet were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Duavive', 'description': 'Participants were administered with Duavive tablet as part of routine practice in Korean health care centers by accredited physicians per the local product document.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.65', 'spread': '5.59', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '639', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Safety analysis set included those participants who had been administered with Duavive tablet at least once and had completed follow up.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-24', 'size': 8575323, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-13T14:47', 'hasProtocol': True}, {'date': '2020-04-21', 'size': 2679784, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-13T14:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 669}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-13', 'studyFirstSubmitDate': '2016-02-19', 'resultsFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2016-06-01', 'lastUpdatePostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-13', 'studyFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 28 days after last dose of study drug (up to 22 months)', 'description': '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.'}, {'measure': 'Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 28 days after last dose of study drug (up to 22 months)', 'description': '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.'}, {'measure': 'Number of Participants Classified According to Measures Taken for Adverse Events', 'timeFrame': 'Baseline up to 28 days after last dose of study drug (up to 22 months)', 'description': '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.'}, {'measure': 'Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 3', 'timeFrame': 'Baseline, Month 3', 'description': '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.'}, {'measure': 'Number of Participants With Change From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Month 6', 'timeFrame': 'Baseline, Month 6', 'description': '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.'}, {'measure': 'Percentage of Participants With Improvement From Baseline in Moderate to Severe Vasomotor Symptoms Associated With Menopause at Last Visit', 'timeFrame': 'Baseline, Last visit (last visit was anytime up to a maximum of Month 21)', 'description': '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.'}, {'measure': 'Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 3', 'timeFrame': 'Month 3', 'description': '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.'}, {'measure': 'Number of Participants With Prevention of Post-menopausal Osteoporosis at Month 6', 'timeFrame': 'Month 6', 'description': '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.'}, {'measure': 'Percentage of Participants With Prevention of Post-menopausal Osteoporosis at Last Visit', 'timeFrame': 'Last visit (last visit was anytime up to a maximum of Month 21)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Severe Vasomotor Symptom Associated With Menopause']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B2311067', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate safety and efficacy of CE/BZA in real practice in Korea'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'General hospital and Primary clinic in Korea', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Severe post menopausal vasomotor symptoms with uterus\n2. postmenopausal osteopenia\n\nExclusion Criteria:\n\n* Women with undiagnosed abnormal uterine bleeding\n* Women with known, suspected, or past history of breast cancer\n* Women with known or suspected estrogen-dependent neoplasia\n* Women with active deep venous thrombosis, pulmonary embolism, or history of these conditions\n* Women with active arterial thromboembolic disease (for example, stroke, myocardial infarction) or history of these conditions\n* Women who are receiving progestin, estrogen, or estrogen-agonists/antagonists\n* Women with hypersensitivity (for example, anaphylaxis, angioedema) to estrogens, bazedoxifene, or any ingredients\n* Women with known hepatic impairment or disease\n* Women with known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders\n* Pregnant women, women who may become pregnant, and nursing mothers\n* Women with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.'}, 'identificationModule': {'nctId': 'NCT02792504', 'briefTitle': 'Post Marketing Surveillance To Observe Safety And Efficacy Of Duavive', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'POST MARKETING SURVEILLANCE TO OBSERVE THE SAFETY AND EFFICACY OF DUAVIVE TAB 0.45MG/20MG', 'orgStudyIdInfo': {'id': 'B2311067'}}, 'contactsLocationsModule': {'locations': [{'zip': '700-721', 'city': 'Jung-gu', 'state': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University/Department of Internal Medicine (Cardiology)'}, {'zip': '01432', 'city': 'Seoul', 'state': 'Dobong-gu', 'country': 'South Korea', 'facility': "Dr. Wang's OB & GY Clinic", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '18442', 'city': 'Hwaseong-si', 'state': 'Dongtan', 'country': 'South Korea', 'facility': 'Kimhyeonmi OBGY', 'geoPoint': {'lat': 37.20682, 'lon': 126.8169}}, {'zip': '425-707', 'city': 'Ansan', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.21795, 'lon': 127.55845}}, {'zip': '14647', 'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Bucheon St. Mary Hospital The Catholic University of Korea', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '463-811', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Baylor Ewha Obgyn Clinic', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '10326', 'city': 'Goyang-si', 'state': 'Ilsandong-gu', 'country': 'South Korea', 'facility': 'Dongguk University Ilsan Medical Center Obstetrics', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '10447', 'city': 'Goyong-si', 'state': 'Ilsandong-gu', 'country': 'South Korea', 'facility': "Obstetrics / Grace Women's Hospital"}, {'zip': '41940', 'city': 'Daegu', 'state': 'Jung-gu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital, Obstetrics', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '602 739', 'city': 'Pusan', 'state': 'Seo-gu', 'country': 'South Korea', 'facility': 'Pusan University Hospital Obstetrics', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'zip': '06591', 'city': 'Seoul', 'state': 'Seocho-gu', 'country': 'South Korea', 'facility': "Catholic Universith of Korea, Seoul ST. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Kangnam-ku', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center, Sungkyunkwan Univ. School of Medicine'}, {'zip': '05030', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital / Department of Internal Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138 736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '139-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sanggye Paik Hospital-Inje University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '143-729', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '156-755', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chungang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '443-380', 'city': 'Suwon', 'country': 'South Korea', 'facility': 'AJOU University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}