Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-02-20 @ 6:20 PM
Study NCT ID:
NCT02808403
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2016-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2016-06-07', 'studyFirstSubmitQcDate': '2016-06-17', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events and adverse drug reactions', 'timeFrame': '2 years', 'description': 'The incidence of adverse events and drug reactions will be described using the same units (events per 1000 person-years). Adverse events (including seriousness and causal relations to drug or device), inclusive of reaction at local injection sites, and other safety information (e.g. overdose, lack of effectiveness, pregnancy and lactation with or without adverse event) will be described.'}, {'measure': 'Laboratory values for LDL-C', 'timeFrame': '2 years'}, {'measure': 'Laboratory values for HDL-C', 'timeFrame': '2 years'}, {'measure': 'Laboratory values for total cholesterol', 'timeFrame': '2 years'}, {'measure': 'Laboratory values for triglycerides', 'timeFrame': '2 years'}, {'measure': 'Laboratory values for Apolipoprotein (Apo) A1', 'timeFrame': '2 years', 'description': 'This will be measured if feasible.'}, {'measure': 'Laboratory values for Apolipoprotein (Apo) Apo B', 'timeFrame': '2 years', 'description': 'This will be measured if feasible.'}, {'measure': 'Laboratory values for Apolipoprotein (Apo) Apo E', 'timeFrame': '2 years', 'description': 'This will be measured if feasible.'}, {'measure': 'Laboratory values for lipoprotein(a)', 'timeFrame': '2 years', 'description': 'This will be measured if feasible.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia', 'Familial Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '39470058', 'type': 'DERIVED', 'citation': 'Yokote K, Ako J, Kitagawa K, Osada N, Sheng F, Sonoda M, Teramoto T. Safety and Effectiveness of Low-Density Lipoprotein Cholesterol-Lowering Therapy With Evolocumab for Familial Hypercholesterolemia/Hypercholesterolemia in Japan: A Real-World, Postmarketing, Single-Arm Study. J Am Heart Assoc. 2024 Nov 5;13(21):e035809. doi: 10.1161/JAHA.124.035809. Epub 2024 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.', 'detailedDescription': 'The objectives of study are to 1) determine the incidence of adverse events and adverse drug reactions among patients receiving evolocumab for up to 2 years, and 2) identify and describe patient characteristics (e.g. demographics, medical history) associated with the safety and effectiveness of evolocumab therapy for the patients with Familial Hypercholesterolemia (Heterozygous or Homozygous) and Hypercholesterolemia in Japan'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients for whom evolocumab is prescribed at participating medical institutions in accordance with the approved Japan prescribing information (i.e., those with Familial Hypercholesterolemia and Hypercholesterolemia who have high risk factors for cardiovascular event and do not respond sufficiently to Hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) for hypercholesterolemia.)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients for whom evolocumab is prescribed at participating medical institutions in accordance with the approved Japan prescribing information (i.e., those with Familial Hypercholesterolemia (Heterozygous or Homozygous and Hypercholesterolemia who have high risk factors for cardiovascular event and do not respond sufficiently to HMGCoA reductase inhibitor (statin) for hypercholesterolemia).\n\nExclusion Criteria:\n\n* No exclusion criteria are applied.'}, 'identificationModule': {'nctId': 'NCT02808403', 'briefTitle': 'Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab (AMG 145) in Japan', 'orgStudyIdInfo': {'id': '20140409'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Evolocumab exposed', 'description': 'Patients for whom evolocumab is prescribed. Dosage, period (start/end date), frequency of injection (Every 2 weeks (Q2W), Every 4 weeks (Q4W)), drug withdrawal (Yes or No, date, reason) and injection site (upper arm, abdomen, thigh) of evolocumab will be collected.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention; observation of routine medical care', 'armGroupLabels': ['Evolocumab exposed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '491-0911', 'city': 'Ichinomiya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.3, 'lon': 136.8}}, {'zip': '494-0001', 'city': 'Ichinomiya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.3, 'lon': 136.8}}, {'zip': '484-0074', 'city': 'Inuyama', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.37995, 'lon': 136.94295}}, {'zip': '487-0016', 'city': 'Kasugai', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.24762, 'lon': 136.97229}}, {'zip': '485-0000', 'city': 'Komaki', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.28333, 'lon': 136.91667}}, {'zip': '454-0933', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '455-8530', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '457-0047', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '457-8511', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '465-0094', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '466-0815', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '466-8560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '496-8537', 'city': 'Tsushima', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.16667, 'lon': 136.71667}}, {'zip': '010-1423', 'city': 'Akita', 'state': 'Akita', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'zip': '012-0037', 'city': 'Yuzawa', 'state': 'Akita', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.16667, 'lon': 140.5}}, {'zip': '289-2511', 'city': 'Asahi', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.71667, 'lon': 140.65}}, {'zip': '260-8677', 'city': 'Chiba', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '297-0203', 'city': 'Chosei Gun', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '299-0111', 'city': 'Ichihara', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.51667, 'lon': 140.08333}}, {'zip': '272-0103', 'city': 'Ichikawa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.73413, 'lon': 139.9065}}, {'zip': '292-0038', 'city': 'Kisarazu', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.38329, 'lon': 139.93254}}, {'zip': '270-2232', 'city': 'Matsudo', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'zip': '791-8026', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '810-0001', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '812-8582', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '815-8588', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '819-1104', 'city': 'Itoshima', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.54225, 'lon': 130.18421}}, {'zip': '802-0001', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'zip': '807-8556', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'zip': '837-0916', 'city': 'Omuta', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.03333, 'lon': 130.45}}, {'zip': '979-0403', 'city': 'Futaba Gun', 'state': 'Fukushima', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '973-8555', 'city': 'Iwaki', 'state': 'Fukushima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.05, 'lon': 140.88333}}, {'zip': '963-8501', 'city': 'Kōriyama', 'state': 'Fukushima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.4, 'lon': 140.38333}}, {'zip': '509-0214', 'city': 'Kani', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.40435, 'lon': 137.05595}}, {'zip': '501-3732', 'city': 'Mino', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.53333, 'lon': 136.91667}}, {'zip': '526-8580', 'city': 'Nagahama City', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '375-0024', 'city': 'Fujioka', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.24624, 'lon': 139.07204}}, {'zip': '376-0011', 'city': 'Kiryū', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.4, 'lon': 139.33333}}, {'zip': '370-3513', 'city': 'Takasaki', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'zip': '720-0001', 'city': 'Fukuyama', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.48333, 'lon': 133.36667}}, {'zip': '739-2104', 'city': 'Higashihiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.40861, 'lon': 132.73682}}, {'zip': '734-8551', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '722-8508', 'city': 'Onomichi', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.41667, 'lon': 133.2}}, {'zip': '068-8555', 'city': 'Iwamizawa', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.20028, 'lon': 141.75972}}, {'zip': '002-8072', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '060-0031', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '062-0003', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '065-0027', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '671-1227', 'city': 'Himeji', 'state': 'Hyogo Prefectural', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.81667, 'lon': 134.7}}, {'zip': '651-1145', 'city': 'Kobe', 'state': 'Hyogo Prefectural', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '651-1351', 'city': 'Kobe', 'state': 'Hyogo Prefectural', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '669-1321', 'city': 'Sanda', 'state': 'Hyogo Prefectural', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.48381, 'lon': 139.3538}}, {'zip': '651-1321', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '654-0155', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '658-0032', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '658-0072', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '311-3193', 'city': 'Higashiibaraki Gun', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '317-0077', 'city': 'Hitachi', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.6, 'lon': 140.65}}, {'zip': '310-0004', 'city': 'Mito', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'zip': '920-0293', 'city': 'Kahoku Gun', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '920-0353', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '920-8530', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '920-8641', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '921-8035', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '920-0293', 'city': 'Mukai-awagasaki', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.63246, 'lon': 136.63726}}, {'zip': '024-0021', 'city': 'Kitakami', 'state': 'Iwate', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.28333, 'lon': 141.11667}}, {'zip': '020-0066', 'city': 'Morioka', 'state': 'Iwate', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'zip': '761-0793', 'city': 'Kita Gun', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '762-8550', 'city': 'Sakaidechō', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.32278, 'lon': 133.8356}}, {'zip': '765-8507', 'city': 'Zentsujichó', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.22699, 'lon': 133.77791}}, {'zip': '890-8760', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '892-0828', 'city': 'Kagoshima', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '893-0013', 'city': 'Kanoya', 'state': 'Kagoshima-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 31.38333, 'lon': 130.85}}, {'zip': '251-0003', 'city': 'Fujisawa', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}, {'zip': '210-0013', 'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '214-0014', 'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '238-0101', 'city': 'Miura', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.14, 'lon': 139.61917}}, {'zip': '231-0806', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '236-0037', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '247-8581', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '238-8558', 'city': 'Yokosuka', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.28361, 'lon': 139.66722}}, {'zip': '238-8567', 'city': 'Yokosuka', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.28361, 'lon': 139.66722}}, {'zip': '240-0195', 'city': 'Yokosuka', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.28361, 'lon': 139.66722}}, {'zip': '860-8515', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '860-8556', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '861-0517', 'city': 'Yamaga', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.01667, 'lon': 130.68911}}, {'zip': '602-8566', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '615-0812', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '625-8585', 'city': 'Maizuru', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.45, 'lon': 135.33333}}, {'zip': '611-0041', 'city': 'Uji', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.89044, 'lon': 135.80325}}, {'zip': '629-2261', 'city': 'Yosa Gun', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '516-8512', 'city': 'Ise', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.48333, 'lon': 136.7}}, {'zip': '514-8507', 'city': 'Tsu', 'state': 'Mie-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.73333, 'lon': 136.51667}}, {'zip': '980-8574', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 38.26667, 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'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '703-8265', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '598-8577', 'city': 'Izumisano', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.41667, 'lon': 135.31667}}, {'zip': '586-8521', 'city': 'Kawachi-Nagano', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.44108, 'lon': 135.58283}}, {'zip': '533-0003', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '537-8511', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '543-0011', 'city': 'Osaka', 'state': 'Osaka', 'country': 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{'lat': 33.88153, 'lon': 135.1696}}, {'zip': '647-0072', 'city': 'Shingū', 'state': 'Wakayama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.73333, 'lon': 135.98333}}, {'zip': '640-8505', 'city': 'Wakayama', 'state': 'Wakayama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}, {'zip': '640-8558', 'city': 'Wakayama', 'state': 'Wakayama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}, {'zip': '400-8506', 'city': 'Kofu', 'state': 'Yamanashi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.66667, 'lon': 138.56667}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'https://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}