Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT01047358
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2009-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C056516', 'term': 'exemestane'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of Aromasin through the end of the study for an average of 5.6 months.', 'description': 'The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Aromasin', 'description': 'Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.', 'otherNumAtRisk': 206, 'otherNumAffected': 40, 'seriousNumAtRisk': 206, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'LEG PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'BILIRUBINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'SERUM GLUTAMIC OXALOACETIC TRANSAMINASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'SERUM GLUTAMIC PYRUVIC TRANSAMINASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'PHOSPHATASE ALKALINE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'SKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'COUGHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'LYMPHOEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}], 'seriousEvents': [{'term': 'CONDITION AGGRAVATED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}, {'term': 'HEPATIC NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'WHO-ART v092'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aromasin', 'description': 'Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.24', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of Aromasin through the end of the study for an average of 5.6 months', 'description': 'All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: included participants who received Aromasin at least once and were evaluated upon its related safety endpoints at least once.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aromasin', 'description': 'Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.95', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the end of the study, average of 5.6 months.', 'description': "The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study. The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant's case report form (CRF).", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set: included all participants who received Aromasin for at least 4 weeks in treatment of breast cancer and had efficacy data available.'}, {'type': 'SECONDARY', 'title': 'Time-to-Progression (Early Breast Cancer)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aromasin', 'description': 'Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.'}], 'timeFrame': 'At the end of the study, average of 5.6 months', 'description': 'Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer.', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was planned to be analyzed in participants with early breast cancer in the efficacy analysis set. However, the analysis was not performed because the data of time-to-progression was not captured in the CRF.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aromasin', 'description': 'Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '4.46', 'groupId': 'OG000'}]}]}, {'title': 'SD', 'categories': [{'measurements': [{'value': '49.11', 'groupId': 'OG000'}]}]}, {'title': 'PD', 'categories': [{'measurements': [{'value': '45.54', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the end of the study, average of 5.6 months', 'description': 'The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions. Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis Set.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aromasin', 'description': 'Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'At least one safety assessment (Safety Population)', 'groupId': 'FG000', 'numSubjects': '206'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled between June 2010 and June 2014 from 25 Korean health care centers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aromasin', 'description': 'Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '9.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '206', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Treatment Indication', 'classes': [{'title': 'Adjuvant Therapy for Early Breast Cancer', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}, {'title': 'Second-Line Therapy for Advanced Cancer', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2009-12-24', 'resultsFirstSubmitDate': '2015-05-26', 'studyFirstSubmitQcDate': '2010-01-08', 'lastUpdatePostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-26', 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From the first dose of Aromasin through the end of the study for an average of 5.6 months', 'description': 'All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)', 'timeFrame': 'At the end of the study, average of 5.6 months.', 'description': "The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study. The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant's case report form (CRF)."}, {'measure': 'Time-to-Progression (Early Breast Cancer)', 'timeFrame': 'At the end of the study, average of 5.6 months', 'description': 'Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer.'}, {'measure': 'Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)', 'timeFrame': 'At the end of the study, average of 5.6 months', 'description': 'The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions. Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5991089&StudyName=Post%20Marketing%20Surveillance%20Study%20To%20Observe%20Safety%20And%20Efficacy%20Of%20Aromasin%20In%20The%20Patients%20With%20Early%20Or%20Advanced%20Breast%20Cancer', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).', 'detailedDescription': 'All cases at the participating institutions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- Postmenopausal women diagnosed as estrogen-receptor positive early breast cancer, who have received two to three years of tamoxifen and are switched to AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy OR postmenopausal women with breast cancer that has progressed following anti-estrogen therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Postmenopausal women with breast cancer eligible for hormonal therapy.\n\nExclusion Criteria:\n\n* Pregnant breast-feeding premenopausal.'}, 'identificationModule': {'nctId': 'NCT01047358', 'briefTitle': 'Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'A5991089'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ajuvant group', 'description': 'adjuvant setting after two to three years of tamoxifen', 'interventionNames': ['Drug: Aromasin']}, {'label': 'palliative group', 'description': 'palliative setting after progression of disease with anti-estrogen therapy', 'interventionNames': ['Drug: Aromasin']}], 'interventions': [{'name': 'Aromasin', 'type': 'DRUG', 'otherNames': ['exemestane'], 'description': '25 mg table QD', 'armGroupLabels': ['ajuvant group']}, {'name': 'Aromasin', 'type': 'DRUG', 'otherNames': ['exemestane'], 'description': '25 mg table QD', 'armGroupLabels': ['palliative group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '330-721', 'city': 'Cheonan', 'state': 'Chungcheongnam-do', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Cheonan', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'zip': '431-070', 'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'zip': '420-767', 'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Bucheon Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '412-270', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Myongji Hospital, Kwangdong Unversity College of Medicine', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '570-749', 'city': 'Iksan -si', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Wonkwang University School of Medicine and Hospital (WUH)'}, {'zip': '138-736', 'city': 'Seoul', 'state': 'Korea', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital (SNUH)', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '519-809', 'city': 'Cheonnam', 'state': 'South Jeolla Province', 'country': 'South Korea', 'facility': 'Hwasun Hospital, Chonnam National University'}, {'zip': '614-735', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '705-717', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeung Nam University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '463-707', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '400-711', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '100-380', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Cheil General Hospital & Women's Healthcare Center", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System, Yonsei Cancer Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135 710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '136-705', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center, University of Ulsan', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '152-703', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Medical Center (KUMC) - Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '156-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'SMG-SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '158-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womans University Mokdong 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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}