Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2026-01-25 @ 3:56 AM
Study NCT ID:
NCT02588261
Status:
TERMINATED
Last Update Posted:
2024-12-10
First Post:
2015-10-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627869', 'term': 'naquotinib'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D000077156', 'term': 'Gefitinib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astellas.resultsdisclosure@astellas.com', 'phone': '1800 888-7704', 'title': 'Senior Medical Director', 'organization': 'Astellas Pharma Global Development, Inc.'}, 'certainAgreement': {'otherDetails': "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the muli-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to 30 days after last dose of study drug taken up to data cut-off 21 Dec 2017 (approximately 22 months)', 'eventGroups': [{'id': 'EG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).', 'otherNumAtRisk': 265, 'deathsNumAtRisk': 265, 'otherNumAffected': 240, 'seriousNumAtRisk': 265, 'deathsNumAffected': 39, 'seriousNumAffected': 84}, {'id': 'EG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).', 'otherNumAtRisk': 262, 'deathsNumAtRisk': 262, 'otherNumAffected': 253, 'seriousNumAtRisk': 262, 'deathsNumAffected': 35, 'seriousNumAffected': 67}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 30, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 21, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 68, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 255, 'numAffected': 161}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 224, 'numAffected': 135}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 31, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 85, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 41, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 70, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 60, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 31, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 39, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 28, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 73, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 47, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 106, 'numAffected': 67}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 125, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 107, 'numAffected': 51}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 67, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 88, 'numAffected': 43}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 28, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 27, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 73, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 64, 'numAffected': 48}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 134, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 35, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 25, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 76, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 41, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 42, 'numAffected': 37}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 377, 'numAffected': 186}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 33, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 83, 'numAffected': 66}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 44, 'numAffected': 35}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Deafness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Retinal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Superinfection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary tract infection enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 9, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Metastases to eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neoplasm skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pharyngeal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 265, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS) as Assessed by Independent Radiologic Review (IRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'OG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.26', 'groupId': 'OG000', 'lowerLimit': '5.62', 'upperLimit': '11.07'}, {'value': '9.59', 'comment': 'Data could not be calculated due to low number of events.', 'groupId': 'OG001', 'lowerLimit': '8.77', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.992', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.611', 'ciLowerLimit': '1.086', 'ciUpperLimit': '2.391', 'groupDescription': 'Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \\< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months)', 'description': 'PFS was defined as the time from the date of randomization until the date of radiological disease progression or until death due to any cause, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by IRR. Results are based Kaplan-Meier estimate. If a participant had neither progressed nor died, who received any further anticancer therapy for the disease before radiological progression, the participant was censored at the date of last radiological assessment. If progression or death occurred after missing 2 scheduled radiological assessments, the participant was censored at the date of last radiological assessment or at the date of randomization if no post-baseline radiological assessment was available.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the full analysis set (FAS), which consisted of all participants who were randomized.'}, {'type': 'SECONDARY', 'title': 'Percentage of Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'OG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '13.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization up to data cut-off date 21 Dec 2017 (approximately 22 months)', 'description': 'All events of death after the first study drug administration were included.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the safety analysis set (SAF), which consisted of all participants who took at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'OG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}], 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000', 'lowerLimit': '27.4', 'upperLimit': '39.0'}, {'value': '47.9', 'groupId': 'OG001', 'lowerLimit': '41.7', 'upperLimit': '54.1'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran-Mantel-Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months)', 'description': 'Percentage of participants with OR was defined as the proportion of participants with best overall response as complete response (CR) or partial response (PR) without confirmation based on the RECIST v1.1 as assessed by the blinded IRR. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS.'}, {'type': 'SECONDARY', 'title': 'PFS as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'OG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.43', 'groupId': 'OG000', 'lowerLimit': '5.49', 'upperLimit': '9.26'}, {'value': '10.12', 'comment': 'Data could not be calculated due to low number of events.', 'groupId': 'OG001', 'lowerLimit': '9.03', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.998', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.674', 'ciLowerLimit': '1.165', 'ciUpperLimit': '2.406', 'groupDescription': 'Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \\< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months)', 'description': 'PFS was defined as the time from the date of randomization until the date of radiological disease progression or until death due to any cause, based on RECIST V1.1, as assessed by local investigator. Results are based Kaplan-Meier estimate. If a participant had neither progressed nor died, who received any further anticancer therapy for the disease before radiological progression, the participant was censored at the date of last radiological assessment. If progression or death occurred after missing 2 scheduled radiological assessments, the participant was censored at the date of last radiological assessment or at the date of randomization if no post-baseline radiological assessment was available.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'OG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}], 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000', 'lowerLimit': '56.1', 'upperLimit': '68.0'}, {'value': '66.2', 'groupId': 'OG001', 'lowerLimit': '60.1', 'upperLimit': '71.9'}]}]}], 'analyses': [{'pValue': '0.839', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran-Mantel-Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months)', 'description': 'Percentage of participants with disease control was defined as the proportion of participants whose best overall response was rated as CR, PR or stable disease (SD) among all analyzed participants based on RECIST V1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'OG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.17', 'comment': 'Data could not be calculated due to low number of events.', 'groupId': 'OG000', 'lowerLimit': '5.45', 'upperLimit': 'NA'}, {'value': '9.03', 'comment': 'Data could not be calculated due to low number of events.', 'groupId': 'OG001', 'lowerLimit': '7.39', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.780', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.298', 'ciLowerLimit': '0.661', 'ciUpperLimit': '2.548', 'groupDescription': 'Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \\< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of first response up to data cut-off date 09 May 2017 (approximately 15 months)', 'description': 'DOR was defined as the time from the date of the first response CR/PR (whichever was first recorded) as assessed by IRR to the date of radiographical progression or date of censoring. If a participant had not progressed, the participant was censored at the date of last radiological assessment or at the date of first CR/PR if no post-baseline radiological assessment was available. Results are based Kaplan-Meier estimate.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the FAS. Only participants with best overall response as CR or PR (without confirmation) were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'OG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}]}, {'title': 'Drug-Related TEAE', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': 'Drug-Related Serious TEAE', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'TEAE Leading to Death', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Drug-Related TEAE Leading to Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TEAE Leading to Treatment Withdrawal', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Drug-Related TEAE Leading to Treatment Withdrawal', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'TEAE Leading to Dose Reduction', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Drug-Related TEAE Leading to Dose Reduction', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'TEAE Leading to Dose Interruption', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Drug-Related TEAE Leading to Dose Interruption', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug up to 30 days after last dose of study drug taken up to data cut-off 09 May 2017', 'description': 'Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was SAF.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy - EGFR Inhibitors Subscale (FACT-EGFRI-18) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'OG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.79', 'spread': '4.97', 'groupId': 'OG000'}, {'value': '9.34', 'spread': '10.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)', 'description': 'ACT-EGFRI-18 is an 18-item Likert-scaled questionnaire, used to assess the effect of EGFR inhibitors on quality of life (QoL). The questionnaire is arranged in three HRQL dimensions: physical (seven items), social/emotional (six items), and functional well-being (five items). The response scores ranged from 0 to 4, and the response categories include "not at all", "a little bit", "somewhat", "quite a bit", and "very much." Negatively worded items (e.g., "My skin bleeds easily "or "My skin condition affects my mood") are reverse-scored, so that participants who experience a higher impact of symptom burden on HRQL receive a lower score (range 0-72).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the SAF, with available data.'}, {'type': 'SECONDARY', 'title': 'European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC-QLQ-LC13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'OG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}], 'classes': [{'categories': [{'measurements': [{'value': '18.93', 'spread': '4.42', 'groupId': 'OG000'}, {'value': '18.78', 'spread': '4.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)', 'description': 'The EORTC-QLQ-LC13 is a validated module of the EORTC-QLQ-Core 30, which includes module items that evaluate symptoms such as cough, hemoptysis, shortness of breath, sore mouth or tongue, dysphagia, tingling hands or feet, hair loss and pain. The total score for the questionnaire ranges from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the SAF, with available data.'}, {'type': 'SECONDARY', 'title': 'European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'OG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}], 'classes': [{'categories': [{'measurements': [{'value': '53.77', 'spread': '11.49', 'groupId': 'OG000'}, {'value': '52.01', 'spread': '11.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)', 'description': 'EORTC-QLQ-LC30 is a 30-item cancer-specific questionnaire with multitrait scaling was used to create five functional domain scales: Physical, Role, Emotional, Social and Cognitive; two items evaluate global QoL; in addition, three symptom scales assess Fatigue, Pain and Emesis; and six single items assess other symptoms. The total score ranges from 0 to 100, with a high score for a functional scale representing a high/healthy level of functioning and a high score for a symptom scale or item representing a high level of symptomatology or problems.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the SAF, with available data.'}, {'type': 'SECONDARY', 'title': 'EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'OG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}], 'classes': [{'title': 'Mobility', 'categories': [{'measurements': [{'value': '1.78', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Self-care', 'categories': [{'measurements': [{'value': '1.28', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Usual Activities', 'categories': [{'measurements': [{'value': '1.71', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Pain/Discomfort', 'categories': [{'measurements': [{'value': '1.79', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety/Depression', 'categories': [{'measurements': [{'value': '1.61', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'VAS', 'categories': [{'measurements': [{'value': '69.44', 'spread': '19.17', 'groupId': 'OG000'}, {'value': '72.36', 'spread': '17.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)', 'description': 'The EQ-5D is a generic preference-based measure that indirectly measures the utility for health that generates an index-based summary score based upon societal preference weights. The EQ-5D-5L consists of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale (VAS) for health status. Each item has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The VAS ranges from 0 (worst health status) and 100 (best health status).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the SAF, with available data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'FG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '267'}, {'groupId': 'FG001', 'numSubjects': '263'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '265'}, {'groupId': 'FG001', 'numSubjects': '262'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '267'}, {'groupId': 'FG001', 'numSubjects': '263'}]}], 'dropWithdraws': [{'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Noncompliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First-line participants with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma NSCLC with EGFR activating mutation (exon 19 deletion or exon 21 L858R) with or without a T790M mutation who had not previously been treated with an EGFR inhibitors were enrolled in 201 sites in 23 countries.', 'preAssignmentDetails': 'Eligible participants were stratified according to the following: Eastern Cooperative Oncology Group (ECOG) performance status (0, 1 or 2), Epidermal growth factor receptor (EGFR) mutation status (exon 19 deletion or mutations in exon 21 \\[L858R\\]), Tyrosine kinase inhibitor (TKI) chosen (erlotinib or gefitinib) and race (Asian versus non-Asian).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'BG001', 'title': 'Erlotinib or Gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '65.8', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '324', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '489', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Investigator Prerandomization Selected TKI at Randomization', 'classes': [{'categories': [{'title': 'Erlotinib', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}, {'title': 'Gefitinib', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG Performance Status at Randomization', 'classes': [{'categories': [{'title': 'Grade 0', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': 'Grade 1', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}, {'title': 'Grade 2', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG Performance Status is composed of 6 grades: 0 - Fully active, able to carry on all predisease performance without restriction; 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2 - Ambulatory and capable of all self-care but unable to carry out any work activities, Up and about more than 50% of waking hours; 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 - Completely disabled, Cannot carry on any self-care, Totally confined to bed or chair; 5 - Dead.', 'unitOfMeasure': 'Participants'}, {'title': 'EGFR Mutation Status at Randomization', 'classes': [{'categories': [{'title': 'Exon 19 Deletion', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}]}, {'title': 'Exon 21 L858R', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (Asian vs Non-Asian) at Randomization', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}, {'title': 'Non-Asian', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis population for all baseline measures consisted of all participants who were randomized in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-19', 'size': 2791539, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-12-07T14:15', 'hasProtocol': True}, {'date': '2016-08-11', 'size': 861488, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-07T14:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 530}}, 'statusModule': {'whyStopped': 'Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2015-10-26', 'resultsFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2015-10-26', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-24', 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) as Assessed by Independent Radiologic Review (IRR)', 'timeFrame': 'From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months)', 'description': 'PFS was defined as the time from the date of randomization until the date of radiological disease progression or until death due to any cause, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by IRR. Results are based Kaplan-Meier estimate. If a participant had neither progressed nor died, who received any further anticancer therapy for the disease before radiological progression, the participant was censored at the date of last radiological assessment. If progression or death occurred after missing 2 scheduled radiological assessments, the participant was censored at the date of last radiological assessment or at the date of randomization if no post-baseline radiological assessment was available.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Deaths', 'timeFrame': 'From date of randomization up to data cut-off date 21 Dec 2017 (approximately 22 months)', 'description': 'All events of death after the first study drug administration were included.'}, {'measure': 'Percentage of Participants With Objective Response (OR)', 'timeFrame': 'From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months)', 'description': 'Percentage of participants with OR was defined as the proportion of participants with best overall response as complete response (CR) or partial response (PR) without confirmation based on the RECIST v1.1 as assessed by the blinded IRR. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.'}, {'measure': 'PFS as Assessed by the Investigator', 'timeFrame': 'From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months)', 'description': 'PFS was defined as the time from the date of randomization until the date of radiological disease progression or until death due to any cause, based on RECIST V1.1, as assessed by local investigator. Results are based Kaplan-Meier estimate. If a participant had neither progressed nor died, who received any further anticancer therapy for the disease before radiological progression, the participant was censored at the date of last radiological assessment. If progression or death occurred after missing 2 scheduled radiological assessments, the participant was censored at the date of last radiological assessment or at the date of randomization if no post-baseline radiological assessment was available.'}, {'measure': 'Percentage of Participants With Disease Control', 'timeFrame': 'From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months)', 'description': 'Percentage of participants with disease control was defined as the proportion of participants whose best overall response was rated as CR, PR or stable disease (SD) among all analyzed participants based on RECIST V1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From date of first response up to data cut-off date 09 May 2017 (approximately 15 months)', 'description': 'DOR was defined as the time from the date of the first response CR/PR (whichever was first recorded) as assessed by IRR to the date of radiographical progression or date of censoring. If a participant had not progressed, the participant was censored at the date of last radiological assessment or at the date of first CR/PR if no post-baseline radiological assessment was available. Results are based Kaplan-Meier estimate.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From first dose of study drug up to 30 days after last dose of study drug taken up to data cut-off 09 May 2017', 'description': 'Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.'}, {'measure': 'Functional Assessment of Cancer Therapy - EGFR Inhibitors Subscale (FACT-EGFRI-18) Questionnaire', 'timeFrame': 'Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)', 'description': 'ACT-EGFRI-18 is an 18-item Likert-scaled questionnaire, used to assess the effect of EGFR inhibitors on quality of life (QoL). The questionnaire is arranged in three HRQL dimensions: physical (seven items), social/emotional (six items), and functional well-being (five items). The response scores ranged from 0 to 4, and the response categories include "not at all", "a little bit", "somewhat", "quite a bit", and "very much." Negatively worded items (e.g., "My skin bleeds easily "or "My skin condition affects my mood") are reverse-scored, so that participants who experience a higher impact of symptom burden on HRQL receive a lower score (range 0-72).'}, {'measure': 'European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC-QLQ-LC13)', 'timeFrame': 'Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)', 'description': 'The EORTC-QLQ-LC13 is a validated module of the EORTC-QLQ-Core 30, which includes module items that evaluate symptoms such as cough, hemoptysis, shortness of breath, sore mouth or tongue, dysphagia, tingling hands or feet, hair loss and pain. The total score for the questionnaire ranges from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.'}, {'measure': 'European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)', 'timeFrame': 'Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)', 'description': 'EORTC-QLQ-LC30 is a 30-item cancer-specific questionnaire with multitrait scaling was used to create five functional domain scales: Physical, Role, Emotional, Social and Cognitive; two items evaluate global QoL; in addition, three symptom scales assess Fatigue, Pain and Emesis; and six single items assess other symptoms. The total score ranges from 0 to 100, with a high score for a functional scale representing a high/healthy level of functioning and a high score for a symptom scale or item representing a high level of symptomatology or problems.'}, {'measure': 'EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)', 'timeFrame': 'Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)', 'description': 'The EQ-5D is a generic preference-based measure that indirectly measures the utility for health that generates an index-based summary score based upon societal preference weights. The EQ-5D-5L consists of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale (VAS) for health status. Each item has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The VAS ranges from 0 (worst health status) and 100 (best health status).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['erlotinib', 'EGFR mutation', 'naquotinib', 'Non-small cell lung cancer (NSCLC)', 'ASP8273', 'gefitinib'], 'conditions': ['Non-small Cell Lung Cancer (NSCLC)']}, 'referencesModule': {'references': [{'pmid': '31070709', 'type': 'DERIVED', 'citation': 'Kelly RJ, Shepherd FA, Krivoshik A, Jie F, Horn L. A phase III, randomized, open-label study of ASP8273 versus erlotinib or gefitinib in patients with advanced stage IIIB/IV non-small-cell lung cancer. Ann Oncol. 2019 Jul 1;30(7):1127-1133. doi: 10.1093/annonc/mdz128.'}], 'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=293', 'label': 'Link to results on the Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.\n\nThis study also assessed Overall survival (OS); Overall response rate (ORR) as assessed by IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR; Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and patient-reported outcome (PRO) parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject agrees not to participate in another interventional study while on treatment.\n* Female subject must either:\n\n * Be of nonchildbearing potential: postmenopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile\n * Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration; And have a negative serum pregnancy test at Screening; And, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least 1 of which must be a highly effective method and one must be a barrier method) starting at Screening and throughout the study period and for 28 days after the final study drug administration.\n* Female subject must not be breastfeeding at Screening or during the study period, and for 28 days after the final study drug administration.\n* Female subject must not donate ova starting at Screening and throughout the study period, and for 28 days after the final study drug administration.\n* Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at Screening and continue throughout the study period and for 90 days after the final study drug administration.\n* Male subject must not donate sperm starting at Screening and throughout the study period and for 90 days after the final study drug administration.\n* Subject has Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Subject has histologically confirmed locally advanced, metastatic or unresectable Stage IIIB/IV adenocarcinoma NSCLC (newly diagnosed or recurrent). Subjects with mixed histology are eligible if adenocarcinoma is the predominant histology.\n* Subject has predicted life expectancy ≥ 12 weeks in the opinion of the investigator.\n* Subject must meet all of the following criteria on the laboratory tests that will be analyzed centrally within 7 days prior to the first dose of study drug. In case of multiple laboratory data within this period, the most recent data should be used.\n\n * Neutrophil count \\> 1,000/mm3\n * Platelet count ≥ 7.5 x 104 /mm3\n * Hemoglobin \\> 8.0 g/dL\n * Serum creatinine ˂ 2.0 x upper limit of normal (ULN) or an estimated glomerular filtration rate (eGFR) of \\> 50 mL/min as calculated by the Cockcroft Gault Method\n * Total bilirubin ˂1.5 x ULN (except for subjects with documented Gilbert's syndrome)\n * AST and ALT ˂ 3.0 x ULN or ≤ 5 x ULN if subject has documented liver metastases\n * Serum sodium level is ≥ 130 mmol/L\n* Subject has an EGFR activating mutation (exon 19 deletion or exon 21 L858R), with or without T790M mutation, by local or central testing on examination of a NSCLC FFPE specimen (archival or fresh biopsy). Subjects harboring both exon 19 deletion and exon 21 L858R mutations are not eligible. A tissue sample from the same block used to determine eligibility by local testing should be available to send to the central lab for confirmatory testing. Subjects randomized based on local results indicating presence of EGFR mutation may remain on study if central results are discordant.\n* Subject must have at least 1 measureable lesion based on RECIST V1.1. Previously irradiated lesions will not be considered as measurable lesions.\n\nExclusion Criteria:\n\n* Subject has received intervening anticancer treatment or previous treatment with chemotherapy for metastatic disease other than palliative local radiation to painful bone metastases completed at least 1 week prior to the first dose of study drug. The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it has finalized ≥ 6 months before the first dose of study drug.\n* Subject has received a prior treatment with a therapeutic agent targeting EGFR (e.g., afatinib, dacomitinib, ASP8273, etc).\n* Subject has received investigational therapy within 28 days or 5 half-lives prior to the first dose of study drug.\n* Subject has received radiotherapy within 1 week prior to the first dose of study drug. If the subject received radiotherapy \\> 1 week prior to study treatment, the irradiated lesion cannot be the only lesion used for evaluating response.\n* Subject has symptomatic central nervous system (CNS) metastasis. Subject with previously treated brain or CNS metastases are eligible provided that the subject has recovered from any acute effects of radiotherapy, does not have brain metastasis related symptoms, is not requiring systemic steroids for at least 2 weeks prior to study drug administration, and any whole brain radiation therapy was completed at least 4 weeks prior to study drug administration, or any stereotactic radiosurgery (SRS) was completed at least 2 weeks prior to study drug administration. Steroid inhaler use or ointment treatment for other concomitant medical disease is permitted.\n* Subject has received blood transfusions or hematopoietic factor therapy within 14 days prior to the first dose of study drug.\n* Subject has had a major surgical procedure (other than a biopsy) within 14 days prior to the first dose of study drug, or one is planned during the course of the study.\n* Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection.\n* Subject has known history of serious hypersensitivity reaction to a known ingredient of ASP8273, erlotinib or gefitinib.\n* Subject has evidence of an active infection requiring systemic therapy within 14 days prior to the planned first dose of study drug.\n* Subject has severe or uncontrolled systemic diseases including uncontrolled hypertension (blood pressure \\> 150/100 mmHg) or active bleeding diatheses.\n* Subject has history of drug-induced interstitial lung disease (ILD) or any evidence of active ILD.\n* Subject has ongoing cardiac arrhythmia that is Grade ≥ 2 or uncontrolled atrial fibrillation of any grade.\n* Subject currently has Class 3 or 4 New York Heart Association congestive heart failure.\n* Subject has history of severe/unstable angina, myocardial infarction or cerebrovascular accident within 6 months prior to the planned first dose of study drug.\n* Subject has history of gastrointestinal ulcer or gastrointestinal bleeding within 3 months prior to the planned first dose of study drug.\n* Subject has concurrent corneal disorder or any ophthalmologic condition which, in the investigator's opinion, makes the subject unsuitable for study participation (i.e., advanced cataracts, glaucoma).\n* Subject has difficulty taking oral medication or any digestive tract dysfunction or inflammatory bowel disease that would interfere with the intestinal absorption of drug.\n* Subject has another past or active malignancy which requires treatment. Prior carcinoma in situ or non-melanoma skin cancer after curative resection are permitted.\n* Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation.\n* Subject has received potent CYP 3A4 inhibitors within 7 days prior to first dose of study drug or proton pump inhibitors such as omeprazole within 14 days prior to first dose of study drug."}, 'identificationModule': {'nctId': 'NCT02588261', 'acronym': 'SOLAR', 'briefTitle': 'A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations', 'orgStudyIdInfo': {'id': '8273-CL-0302'}, 'secondaryIdInfos': [{'id': '2015-002894-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP8273', 'description': 'Participants received 300 mg of ASP8273 orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).', 'interventionNames': ['Drug: naquotinib mesilate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'erlotinib or gefitinib', 'description': 'Participants received 150 mg of erlotinib or 250 mg of gefitinib orally once daily in 28-day cycles until one of the discontinuation criteria was met (developed radiological progressive disease, required to receive local or systemic anti-cancer treatment, developed unacceptable toxicity, participant pregnancy, investigator decision, required to receive significant surgical procedure, participant protocol deviation or noncompliance, participant decline of further treatment and participant lost to follow-up).', 'interventionNames': ['Drug: Erlotinib', 'Drug: Gefitinib']}], 'interventions': [{'name': 'naquotinib mesilate', 'type': 'DRUG', 'otherNames': ['ASP8273'], 'description': 'Participants received ASP8273 300 mg orally once daily on an empty stomach (no food for at least 2 hours before and 1 hour after taking drug) at approximately the same time every day.', 'armGroupLabels': ['ASP8273']}, {'name': 'Erlotinib', 'type': 'DRUG', 'otherNames': ['Tarceva', 'OSI-774'], 'description': 'Participants received erlotinib 150 mg orally once daily on an empty stomach (no food for at least 2 hours before and 1 hour after taking drug) at approximately the same time every day. At the beginning of the trial, prior to site initiation and shipment of study drug supplies, each investigator selected either erlotinib or gefitinib to be utilized for all participants randomized to the comparator arm at their site.', 'armGroupLabels': ['erlotinib or gefitinib']}, {'name': 'Gefitinib', 'type': 'DRUG', 'description': 'Participants received gefitinib 250 mg was taken orally once daily with water, with or without food, at approximately the same time every day. At the beginning of the trial, prior to site initiation and shipment of study drug supplies, each investigator selected either erlotinib or gefitinib to be utilized for all participants randomized to the comparator arm at their site.', 'armGroupLabels': ['erlotinib or gefitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Site US10029', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90806', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Site US10025', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Site US10036', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Site US10051', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Site US10033', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93030', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': 'Site US10031', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Site US10052', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Site US10003', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Site US10018', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '81601', 'city': 'Glenwood Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Site US10047', 'geoPoint': {'lat': 39.55054, 'lon': -107.32478}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Site US10013', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Site US10048', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Site US10050', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Site US10042', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'Site US10037', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Site US10034', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Site US10030', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Site US10027', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Site US10045', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10549', 'city': 'Mount Kisco', 'state': 'New York', 'country': 'United States', 'facility': 'Site US10012', 'geoPoint': {'lat': 41.20426, 'lon': -73.72708}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site US10021', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Site US10009', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Site US10023', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98503', 'city': 'Lacey', 'state': 'Washington', 'country': 'United States', 'facility': 'Site US10011', 'geoPoint': {'lat': 47.03426, 'lon': -122.82319}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Site US10046', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Site AU61003', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Site AU61007', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Site AU61005', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Site AU61008', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Site AU61002', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '3011', 'city': 'Footscray', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Site AU61004', 'geoPoint': {'lat': -37.8, 'lon': 144.9}}, {'zip': '9000', 'city': 'Ghent', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Site BE32002', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Site CA15006', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H49 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Site CA15002', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '2520612', 'city': 'Viña del Mar', 'state': 'Región de Valparaíso', 'country': 'Chile', 'facility': 'Site CL56002', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'zip': '2540364', 'city': 'Viña del Mar', 'state': 'Región de Valparaíso', 'country': 'Chile', 'facility': 'Site CL56007', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'zip': '8380455', 'city': 'Santiago', 'state': 'Región Metropolitana de Santia', 'country': 'Chile', 'facility': 'Site CL56001', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '33604', 'city': 'Pessac', 'state': 'Gironde', 'country': 'France', 'facility': 'Site FR33010', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '92150', 'city': 'Suresnes', 'state': 'Hauts-de-Seine', 'country': 'France', 'facility': 'Site FR33011', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '94010', 'city': 'Créteil', 'state': 'Ilej-de-France', 'country': 'France', 'facility': 'Site FR33003', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '37044', 'city': 'Tours', 'state': 'Indre-et-Loire', 'country': 'France', 'facility': 'Site FR33004', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '38043', 'city': 'Grenoble', 'state': 'Isère', 'country': 'France', 'facility': 'Site FR33006', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '42270', 'city': 'Saint Priest En Jarez', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'Site FR33009'}, {'zip': '64100', 'city': 'Bayonne', 'state': 'Pyrénées-Atlantiques', 'country': 'France', 'facility': 'Site FR33012', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'state': 'Rhône', 'country': 'France', 'facility': 'Site FR33007', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Site DE49008', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '76137', 'city': 'Karlsruhe', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Site DE49005', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '82131', 'city': 'Gauting', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Site DE49003', 'geoPoint': {'lat': 48.06919, 'lon': 11.37703}}, {'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Site DE49006', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '34125', 'city': 'Kassel', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Site DE49007', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'zip': '51109', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Site DE49004', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': 'H 8000', 'city': 'Székesfehérvár', 'state': 'Fejér', 'country': 'Hungary', 'facility': 'Site HU36002', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'zip': 'H-2800', 'city': 'Tatabánya', 'state': 'Tatabánya', 'country': 'Hungary', 'facility': 'Site HU36003', 'geoPoint': {'lat': 47.59247, 'lon': 18.38099}}, {'zip': 'H 9700', 'city': 'Szombathely', 'state': 'Vas County', 'country': 'Hungary', 'facility': 'Site HU36006', 'geoPoint': {'lat': 47.23088, 'lon': 16.62155}}, {'zip': '8582', 'city': 'Farkasgyepű', 'state': 'Veszprém megye', 'country': 'Hungary', 'facility': 'Site HU36004', 'geoPoint': {'lat': 47.2, 'lon': 17.63333}}, {'zip': '1121', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Site HU36007', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1125', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Site HU36001', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '20052', 'city': 'Monza', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Site IT39004', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Site IT39009', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '33081', 'city': 'Aviano', 'state': 'Pordenone', 'country': 'Italy', 'facility': 'Site IT39011', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'zip': '24127', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Site IT39003', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Site IT39015', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '26100', 'city': 'Cremona', 'country': 'Italy', 'facility': 'Site IT39002', 'geoPoint': {'lat': 45.13325, 'lon': 10.02129}}, {'zip': '55100', 'city': 'Lucca', 'country': 'Italy', 'facility': 'Site IT39013', 'geoPoint': {'lat': 43.84369, 'lon': 10.50447}}, {'zip': '20142', 'city': 'Milan', 'country': 'Italy', 'facility': 'Site IT39014', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '29100', 'city': 'Piacenza', 'country': 'Italy', 'facility': 'Site IT39012', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'zip': '00128', 'city': 'Roma', 'country': 'Italy', 'facility': 'Site IT39008', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '791-0280', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Site JP81018', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '730-8518', 'city': 'Hiroshima', 'state': 'Hirosima [Hiroshima]', 'country': 'Japan', 'facility': 'Site JP81013', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '003-0804', 'city': 'Sapporo', 'state': 'Hokkaidô', 'country': 'Japan', 'facility': 'Site JP81014', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '589-8511', 'city': 'Osakasayama-shi', 'state': 'Hukuoka [Fukuoka]', 'country': 'Japan', 'facility': 'Site JP81017'}, {'zip': '830-0011', 'city': 'Kurume', 'state': 'Hukuoka', 'country': 'Japan', 'facility': 'Site JP81008', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'zip': '650-0047', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Site JP81024', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '920-8530', 'city': 'Kanazawa', 'state': 'Isikawa [Ishikawa]', 'country': 'Japan', 'facility': 'Site JP81015', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '236-0051', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Site JP81010', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '241-8515', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Site JP81025', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '980-0873', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Site JP81012', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '710-8602', 'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Site JP81016', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'zip': '534-0021', 'city': 'Miyakojima-ku', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Site JP81005'}, {'zip': '569-8511', 'city': 'Osakasayama-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Site JP81020'}, {'zip': '411-8777', 'city': 'Sunto-gun', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Site JP81019'}, {'zip': '411-8777', 'city': 'Sunto-gun', 'state': 'Sizuoka [Shizuoka]', 'country': 'Japan', 'facility': 'Site JP81001'}, {'zip': '135-8550', 'city': 'Tokyo', 'state': 'Tôkyô [Tokyo]', 'country': 'Japan', 'facility': 'Site JP81004', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '951-8122', 'city': 'Niigata', 'country': 'Japan', 'facility': 'Site JP81022', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '700-8558', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Site JP81006', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '641-8510', 'city': 'Wakayama', 'country': 'Japan', 'facility': 'Site JP81023', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}, {'zip': '573-1191', 'city': 'Hirakata', 'state': 'Ôsaka [Osaka]', 'country': 'Japan', 'facility': 'Site JP81021', 'geoPoint': {'lat': 34.81352, 'lon': 135.64914}}, {'zip': '589-8511', 'city': 'Ōsaka-sayama', 'state': 'Ôsaka [Osaka]', 'country': 'Japan', 'facility': 'Site JP81002', 'geoPoint': {'lat': 34.49524, 'lon': 135.55069}}, {'zip': '25100', 'city': 'Kuantan Pahang', 'state': 'Pahang', 'country': 'Malaysia', 'facility': 'Site MY60001'}, {'zip': '10450', 'city': 'George Town', 'state': 'Pulau Pinang', 'country': 'Malaysia', 'facility': 'Site MY60002', 'geoPoint': {'lat': 5.41123, 'lon': 100.33543}}, {'zip': '93586', 'city': 'Kuching', 'state': 'Sarawak', 'country': 'Malaysia', 'facility': 'Site MY60004', 'geoPoint': {'lat': 1.55, 'lon': 110.33333}}, {'zip': '6815 AD', 'city': 'Arnhem', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Site NL31001', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': '1815 JD', 'city': 'Alkmaar', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Site NL31006', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'zip': '04001', 'city': 'Cercado de Lima', 'state': 'Arequipa', 'country': 'Peru', 'facility': 'Site PE51001'}, {'zip': 'L18', 'city': 'Miraflores', 'state': 'Lima region', 'country': 'Peru', 'facility': 'Site PE51008', 'geoPoint': {'lat': -12.11331, 'lon': -77.03274}}, {'zip': '1501', 'city': 'San Isidro', 'state': 'Lima region', 'country': 'Peru', 'facility': 'Site PE51004', 'geoPoint': {'lat': -12.09655, 'lon': -77.04258}}, {'zip': '2720-276', 'city': 'Amadora', 'state': 'Lisbon District', 'country': 'Portugal', 'facility': 'Site PT35101', 'geoPoint': {'lat': 38.75382, 'lon': -9.23083}}, {'zip': '1099-023', 'city': 'Lisbon', 'state': 'Lisbon District', 'country': 'Portugal', 'facility': 'Site PT35104', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '3041-801', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Site PT35103', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '1400-038', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Site PT35102', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '407280', 'city': 'Floreşti', 'state': 'Cluj', 'country': 'Romania', 'facility': 'Site RO40004', 'geoPoint': {'lat': 46.74574, 'lon': 23.49375}}, {'zip': '200347', 'city': 'Craiova', 'state': 'Dolj', 'country': 'Romania', 'facility': 'Site RO40001', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '200385', 'city': 'Craiova', 'state': 'Dolj', 'country': 'Romania', 'facility': 'Site RO40010', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '100010', 'city': 'Ploieşti', 'state': 'Prahova', 'country': 'Romania', 'facility': 'Site RO40007', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'zip': '300210', 'city': 'Timișoara', 'state': 'Timiș County', 'country': 'Romania', 'facility': 'Site RO40008', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '031422', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Site RO40012', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '550245', 'city': 'Sibiu', 'country': 'Romania', 'facility': 'Site RO40006', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'zip': '163045', 'city': 'Arkhangelsk', 'state': 'Arkhangelskaya oblast', 'country': 'Russia', 'facility': 'Site RU70012', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '450054', 'city': 'Ufa', 'state': 'Bashkortostan Republic', 'country': 'Russia', 'facility': 'Site RU70017', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '455001', 'city': 'Magnitogorsk', 'state': 'Chelyabinsk Oblast', 'country': 'Russia', 'facility': 'Site RU70009', 'geoPoint': {'lat': 53.39808, 'lon': 59.0066}}, {'zip': '360000', 'city': "Nal'chik", 'state': 'Kabardino-Balkarskaya Respublika', 'country': 'Russia', 'facility': 'Site RU70016', 'geoPoint': {'lat': 43.49806, 'lon': 43.61889}}, {'zip': '357502', 'city': 'Pyatigorsk', 'state': 'Stavropol Kray', 'country': 'Russia', 'facility': 'Site RU70008', 'geoPoint': {'lat': 44.05, 'lon': 43.05036}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Site RU70001', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '188770', 'city': 'Singapore', 'state': 'Central Singapore', 'country': 'Singapore', 'facility': 'Site SG65001', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '308433', 'city': 'Singapore', 'state': 'Central Singapore', 'country': 'Singapore', 'facility': 'Site SG65002', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '48108', 'city': "Busan Gwang'yeogsi", 'state': "Busan Gwang'yeogsi", 'country': 'South Korea', 'facility': 'Site KR82010'}, {'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Site KR82004', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '16427', 'city': 'Suwon', 'state': 'Gyeonggido [Kyonggi-do]', 'country': 'South Korea', 'facility': 'Site KR82016', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '13620', 'city': 'Bundang', 'state': 'Gyeonggido', 'country': 'South Korea', 'facility': 'Site KR82017'}, {'zip': '660-702', 'city': 'Jinju', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Site KR82009', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'zip': '54907', 'city': 'Jeonju', 'state': 'Jeonrabugdo[Chollabuk-do]', 'country': 'South Korea', 'facility': 'Site KR82003', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'zip': '28644', 'city': 'Cheongiu', 'state': 'North Chungcheong', 'country': 'South Korea', 'facility': 'Site KR82005'}, {'zip': '028-481', 'city': 'Seoul', 'state': "Seoul Teugbyeolsi [Seoul-T'ukp]", 'country': 'South Korea', 'facility': 'Site KR82002', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'state': "Seoul Teugbyeolsi [Seoul-T'ukp]", 'country': 'South Korea', 'facility': 'Site KR82001', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-720', 'city': 'Seoul', 'state': "Seoul Teugbyeolsi [Seoul-T'ukp]", 'country': 'South Korea', 'facility': 'Site KR82013', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '139-706', 'city': 'Seoul', 'state': "Seoul Teugbyeolsi [Seoul-T'ukp]", 'country': 'South Korea', 'facility': 'Site KR82007', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '152-703', 'city': 'Seoul', 'state': "Seoul Teugbyeolsi [Seoul-T'ukp]", 'country': 'South Korea', 'facility': 'Site KR82008', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '156-707', 'city': 'Seoul', 'state': "Seoul Teugbyeolsi [Seoul-T'ukp]", 'country': 'South Korea', 'facility': 'Site KR82006', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '5368', 'city': 'Seoul', 'state': "Seoul Teugbyeolsi [Seoul-T'ukp]", 'country': 'South Korea', 'facility': 'Site KR82015', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '130-701', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Site KR82014', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '682-714', 'city': 'Ulsan', 'state': "Ulsan Gwang'yeogsi", 'country': 'South Korea', 'facility': 'Site KR82011', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Site ES34003', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '20014', 'city': 'San Sebastian, Guipuzcoa', 'state': 'Guipúzcoa', 'country': 'Spain', 'facility': 'Site ES34008', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Site ES34010', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Site ES34006', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Site ES34016', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '32004', 'city': 'Ourense', 'country': 'Spain', 'facility': 'Site ES34004', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'Site ES34005', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Site ES34015', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46014', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Site ES34017', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Site ES34002', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '40447', 'city': 'Taichung', 'state': 'Taichung', 'country': 'Taiwan', 'facility': 'Site TW88605', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '33305', 'city': 'Taoyuan Hsien', 'state': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Site TW88607'}, {'zip': '83301', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Site TW88606', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Site TW88603', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '70403', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Site TW88601', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '736', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Site TW88604', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Site TW88608', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Site TW88609', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11490', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Site TW88611', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '50200', 'city': 'Chom Thong', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Site TH66011', 'geoPoint': {'lat': 18.41742, 'lon': 98.67428}}, {'zip': '10330', 'city': 'Bangkok', 'state': 'Krung Thep Maha Nakhon [Bangkok]', 'country': 'Thailand', 'facility': 'Site TH66001', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10400', 'city': 'Bangkok', 'state': 'Krung Thep Maha Nakhon [Bangkok]', 'country': 'Thailand', 'facility': 'Site TH66012', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '57000', 'city': 'Chiang Rai', 'country': 'Thailand', 'facility': 'Site TH66002', 'geoPoint': {'lat': 19.90858, 'lon': 99.8325}}, {'zip': '40002', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Site TH66004', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '90110', 'city': 'Songkhla', 'country': 'Thailand', 'facility': 'Site TH66006', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}, {'zip': '58013', 'city': 'Chernivtsi', 'state': 'Chernivtsi Oblast', 'country': 'Ukraine', 'facility': 'Site UA38006', 'geoPoint': {'lat': 48.29045, 'lon': 25.93241}}, {'zip': '49102', 'city': 'Dnipropetrovsk', 'state': 'Dnipropetrovsk Oblast', 'country': 'Ukraine', 'facility': 'Site UA38001', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '50048', 'city': 'Kryvyi Rih', 'state': 'Dnipropetrovsk Oblast', 'country': 'Ukraine', 'facility': 'Site UA38005', 'geoPoint': {'lat': 47.90572, 'lon': 33.39404}}, {'zip': '76000', 'city': 'Ivano-Frankivsk', 'state': 'Ivano-Frankivsk Oblast', 'country': 'Ukraine', 'facility': 'Site UA38008', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '79031', 'city': 'Lviv', 'state': 'Lviv Oblast', 'country': 'Ukraine', 'facility': 'Site UA38004', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': '43018', 'city': 'Lutsk', 'state': 'Volyn Oblast', 'country': 'Ukraine', 'facility': 'Site UA38007', 'geoPoint': {'lat': 50.75784, 'lon': 25.35024}}, {'zip': '88000', 'city': 'Uzhhorod', 'state': 'Zakarpattia Oblast', 'country': 'Ukraine', 'facility': 'Site UA38009', 'geoPoint': {'lat': 48.6242, 'lon': 22.2947}}, {'zip': '88014', 'city': 'Uzhhorod', 'state': 'Zakarpattia Oblast', 'country': 'Ukraine', 'facility': 'Site UA38003', 'geoPoint': {'lat': 48.6242, 'lon': 22.2947}}, {'zip': 'HA6 2RN', 'city': 'Middlesex', 'state': 'Hertfordshire', 'country': 'United Kingdom', 'facility': 'Site GB44002', 'geoPoint': {'lat': 51.53174, 'lon': -0.26856}}, {'zip': 'CH63 4JY', 'city': 'Liverpool', 'state': 'Wirral', 'country': 'United Kingdom', 'facility': 'Site GB44001', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'S10 2SJ', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Site GB44003', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development, Inc.'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicaltrials.astellas.com/transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data..', 'ipdSharing': 'YES', 'description': "Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.", 'accessCriteria': 'Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Global Development, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}