Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-30 @ 8:49 AM
Study NCT ID:
NCT01387932
Status:
TERMINATED
Last Update Posted:
2021-11-30
First Post:
2011-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Egypt']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D051184', 'term': 'Desmoglein 3'}, {'id': 'D004998', 'term': 'Ethiodized Oil'}, {'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D051182', 'term': 'Desmogleins'}, {'id': 'D051181', 'term': 'Desmosomal Cadherins'}, {'id': 'D015820', 'term': 'Cadherins'}, {'id': 'D015815', 'term': 'Cell Adhesion Molecules'}, {'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001324', 'term': 'Autoantigens'}, {'id': 'D007459', 'term': 'Iodized Oil'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vicky.brunk@merit.com', 'phone': '+1 (717) 873-3309', 'title': 'Vicky Brunk RN, Vice President, Medical Affairs, Merit Medical', 'organization': 'Merit Medical Systems, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was terminated early due to insufficient enrolment to support analysis of endpoints. A full safety analysis was completed and is reported.'}}, 'adverseEventsModule': {'timeFrame': 'All adverse events (AEs) occurring between the date of randomization until study termination, an average of 25.8 and 28.0 months per participant in the hqTACE and cTACE arms respectively.', 'eventGroups': [{'id': 'EG000', 'title': 'HepaSphere/QuadraSphere TACE', 'description': 'HepaSphere/QuadraSphere TACE\n\nTransarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing HepaSphere/QuadraSphere Microspheres loaded with doxorubicin.', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 86, 'seriousNumAtRisk': 111, 'deathsNumAffected': 100, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Conventional TACE', 'description': 'Conventional TACE\n\nTransarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing PVA, lipiodol, doxorubicin.', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 87, 'seriousNumAtRisk': 113, 'deathsNumAffected': 93, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 40, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 40, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 48, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 45, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 32, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Post embolisation syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 39, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 38, 'numAffected': 21}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alpha 1 foetoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Duodenal ulcer hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mesenteric vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oesophageal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oesophageal varices hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Varices oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hepatic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Enterococcal bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Peritonitis bacteria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Post embolisation syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Food intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HepaSphere/QuadraSphere TACE', 'description': 'HepaSphere/QuadraSphere TACE\n\nHepaSphere/QuadraSphere Microspheres: HepaSphere/QuadraSphere Microspheres loaded with doxorubicin'}, {'id': 'OG001', 'title': 'Conventional TACE', 'description': 'Conventional TACE\n\nPVA, lipiodol, doxorubicin: Conventional TACE procedure using PVA, lipiodol and doxorubicin'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '8.02', 'upperLimit': '9.99'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '3.39', 'upperLimit': '10.61'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 years', 'description': 'Median overall survival will be calculated using the Intent-to-Treat (ITT) population in each treatment arm when the last subject has completed two years of follow up after their first study TACE procedure. Per protocol, study subjects were followed for survival until death or deemed lost to follow up. All deaths are reported within safety.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis populations for both the HepaSphere/QuadraSphere TACE (hqTACE) and conventional TACE (cTACE) arms included all subjects with HCC that received one or more protocol specified TACE procedures.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rates (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HepaSphere/QuadraSphere TACE', 'description': 'HepaSphere/QuadraSphere TACE\n\nTransarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing HepaSphere/QuadraSphere Microspheres loaded with doxorubicin.'}, {'id': 'OG001', 'title': 'Conventional TACE', 'description': 'Conventional TACE\n\nTransarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing PVA, lipiodol, doxorubicin.'}], 'timeFrame': 'Study was terminated early so analysis of additional outcome(s) were not possible.', 'description': 'The Objective Response Rate will be calculated for the ITT population by adding the number of participants that were determined to have complete or partial response (utilizing mRECIST criteria) and dividing by the number of ITT participants.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of TACE-Related Adverse Events in Subjects Treated With HepaSphere/QuadraSphere vs Subjects Treated With Conventional TACE.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HepaSphere/QuadraSphere TACE', 'description': 'HepaSphere/QuadraSphere TACE\n\nTransarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing HepaSphere/QuadraSphere Microspheres loaded with doxorubicin.'}, {'id': 'OG001', 'title': 'Conventional TACE', 'description': 'Conventional TACE\n\nTransarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing PVA, lipiodol, doxorubicin.'}], 'classes': [{'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The number of TACE- Related adverse events experienced by subjects treated with HepaSphere/QuadraSphere will be compared to the number of TACE-related adverse events experienced by subjects treated with conventional TACE.\n\nAdverse events were recorded for treated subjects from the date of randomization up to and including 30 days post the last study MRI.', 'unitOfMeasure': 'A TACE related Adverse Event', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis populations were: 1. All subjects treated with HepaSphere/QuadraSphere TACE and 2. All subjects treated with conventional TACE.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HepaSphere/QuadraSphere TACE', 'description': 'HepaSphere/QuadraSphere TACE\n\nTransarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing HepaSphere/QuadraSphere Microspheres loaded with doxorubicin.'}, {'id': 'FG001', 'title': 'Conventional TACE', 'description': 'Conventional TACE\n\nTransarterial chemoembolization in participants with localized, non-resectable hepatocellular carcinoma utilizing PVA, lipiodol, doxorubicin.'}], 'periods': [{'title': 'Randomized and Treated', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Completion of TACE Cycle', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'comment': 'One hundred percent of the hqTACE arm and 100% of the cTACE arm received their first TACE Cycle.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Survival Follow-up', 'milestones': [{'type': 'STARTED', 'comment': 'All subjects that completed at least one TACE cycle were eligible for long-term survival follow-up.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '90'}]}], 'dropWithdraws': [{'type': 'Liver Transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Additional treatment excluding liver transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Study enrollment began in June 2011 and ended in May 2017.', 'preAssignmentDetails': 'Of the 235 subjects that were randomized, 224 were treated. Eleven (11) randomized subjects did not receive treatment, 5 of which were not treated at the investigators discretion and 6 that withdrew consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HepaSphere/QuadraSphere TACE', 'description': 'HepaSphere/QuadraSphere TACE\n\nHepaSphere/QuadraSphere Microspheres: HepaSphere/QuadraSphere Microspheres loaded with doxorubicin'}, {'id': 'BG001', 'title': 'Conventional TACE', 'description': 'Conventional TACE\n\nPVA, lipiodol, doxorubicin: Conventional TACE procedure using PVA, lipiodol and doxorubicin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.0', 'spread': '8.95', 'groupId': 'BG000'}, {'value': '64.2', 'spread': '8.40', 'groupId': 'BG001'}, {'value': '64.1', 'spread': '8.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'RACE (NIH/OMB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The Analysis Population is the 224 treated subjects and not the 235 randomized subjects, as the 11 subjects either withdrew consent or did not receive any study treatments as they were deemed ineligible by the treating investigator.'}], 'populationDescription': 'Baseline Analysis Population are the number of subjects that were randomized to that study arm.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-04-21', 'size': 8099445, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-26T11:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Participants are blinded to the treatment they are randomized to (cTACE or hqTACE). Central Reviewers (two interventional radiologists) will evaluate study participant's liver MRIs to assess the tumor response. The Central Reviewers will be blinded to the treatment the participant received."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized 1:1 to receive either 1. A Conventional TACE (Trans Arterial Chemoembolization) procedure using PVA, lipiodol and doxorubicin (cTACE), or 2. HepaSphere/QuadraSphere Microspheres loaded with doxorubicin for Trans Arterial Chemoembolization (hqTACE). Participants in both treatment arms will be followed for overall survival, the primary study endpoint.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 235}}, 'statusModule': {'whyStopped': 'The clinical study was terminated due to the inability to meet target enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-02', 'studyFirstSubmitDate': '2011-04-11', 'resultsFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2011-07-05', 'lastUpdatePostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-02', 'studyFirstPostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of TACE-Related Adverse Events in Subjects Treated With HepaSphere/QuadraSphere vs Subjects Treated With Conventional TACE.', 'timeFrame': '30 days', 'description': 'The number of TACE- Related adverse events experienced by subjects treated with HepaSphere/QuadraSphere will be compared to the number of TACE-related adverse events experienced by subjects treated with conventional TACE.\n\nAdverse events were recorded for treated subjects from the date of randomization up to and including 30 days post the last study MRI.'}], 'primaryOutcomes': [{'measure': 'Median Overall Survival', 'timeFrame': '2 years', 'description': 'Median overall survival will be calculated using the Intent-to-Treat (ITT) population in each treatment arm when the last subject has completed two years of follow up after their first study TACE procedure. Per protocol, study subjects were followed for survival until death or deemed lost to follow up. All deaths are reported within safety.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rates (ORR)', 'timeFrame': 'Study was terminated early so analysis of additional outcome(s) were not possible.', 'description': 'The Objective Response Rate will be calculated for the ITT population by adding the number of participants that were determined to have complete or partial response (utilizing mRECIST criteria) and dividing by the number of ITT participants.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'TACE', 'HepaSphere Microspheres', 'QuadraSphere Microspheres', 'Doxorubicin'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate overall survival in patients diagnosed with hepatocellular cancer (HCC) treated with HepaSphere/QuadraSphere Microspheres loaded with chemotherapeutic agent doxorubicin compared to conventional transarterial chemoembolization with particle PVA, lipiodol, and doxorubicin.', 'detailedDescription': "This phase three, interventional, and prospective study consists of a patient population that has advanced liver cancer (hepatocellular cancer \\[HCC\\]) that cannot be removed by standard therapies such as surgical removal, liver transplant, and/or ablation.\n\nEmbolics and drug eluting embolics are being used by interventional radiologists to try and shrink or kill the tumor area.\n\nPatients that met eligibility criteria, wanted to participate in the study, and signed the informed consent form (ICF) made up the study subject population. Subjects were randomized on a 1:1 basis (subjects were blinded to arm they were randomized to).\n\nPost randomization and within four weeks of the first chemoembolization procedure all subjects had a baseline MRI. Following, the first chemoembolization procedure (hqTACE or cTACE) or 'cycle' was completed. Subjects can (per protocol) receive up to 3 TACE cycles. Within 4 weeks after any TACE cycle, an MRI and labs should be conducted/collected to evaluate disease status (reduction vs progression) and measure treated lesions. Any residual disease that is present after after the first TACE will undergo the next TACE cycle (maximum of three). However, if the liver MRI shows a complete response (absence of HCC) then no additional TACE procedures are performed and the subject is followed for survival."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must meet all of the following inclusion criteria in order to be entered into the study:\n\n1. Age 18 or older\n2. Patient has signed informed consent\n3. Patient must have a diagnosis of hepatocellular cancer confirmed by at least one of the following:\n\ni. Histological confirmation ii. Magnetic resonance imaging (MRI) result with early enhancement and delayed enhancement washout of at least one solid liver lesion \\> 1 cm. Patient must also have evidence of cirrhosis or have chronic hepatitis B.\n\niii. Contrast enhanced computed tomography (CT) with early enhancement and delayed enhancement washout of at least one solid liver lesion \\> 1cm. Patient must also have evidence of cirrhosis or have chronic hepatitis B.\n\nd. Patient must not be suitable for treatment by resection or percutaneous ablation at time of study entry.\n\nPatients not suitable for ablation due to lesion location may be enrolled\n\ne. Patient MUST meet at least ONE of the following criteria:\n\ni. Stage Child-Pugh B 7 ii. Recurrent HCC iii.Performance status ECOG 1\n\nf. Patient has a life expectancy of at least 6 months\n\ng. Absence of occlusive thrombus to the main portal trunk\n\nExclusion Criteria:\n\nIf patients meet any of the following criteria they may not be entered into the study:\n\n1. Current or previous treatment with chemo- or radiation therapy or sorafenib\n2. Previous treatment with any form of transarterial embolization for HCC\n3. Patients with current or history of any other cancer except non-melanomatous skin cancer\n4. Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive\n5. Performance status ECOG \\> 2\n6. Child-Pugh scores \\>7\n7. Active gastrointestinal bleeding\n8. Evidence of uncorrectable bleeding diathesis\n9. Extra-hepatic spread of the HCC\n10. Total Bilirubin \\> 3 mg/dL\n11. \\>50% tumor involvement of the liver\n12. Infiltrative or diffuse HCC\n13. Encephalopathy not adequately controlled medically\n14. Presence of ascites not controlled medically\n15. Presence of medically relevant localized or systemic infection, other than hepatitis B, C, D, E or G\n16. Any contraindication for MRI (eg. metallic implants)\n17. Allergy to contrast media that cannot be managed with prophylaxis\n18. Allergy to iodized oil\n19. Any contraindication to arteriography\n20. Any contraindication for doxorubicin administration, including the following:\n\ni. White Blood Cell count (WBC) \\<3000 cells/mm₃\n\nii. Absolute Neutrophil \\<1500 cells/mm₃\n\niii. Cardiac ejection fraction \\<50%\n\niv. Other condition deemed exclusionary by physician\n\nu. Any contraindication for hepatic embolization, including the following:\n\ni. Porto-systemic shunt, or an arteriovenous shunt that cannot be adequately closed prior to chemoembolization\n\nii. Hepatofugal blood flow\n\niii. Serum creatinine \\> 2mg/dL\n\niv. Uncorrectable impaired clotting\n\n1. Platelet \\<50,000/mm₃\n2. International Normalized Ratio (INR) \\> 1.4\n3. Activated Prothrombin Time (aPTT) less than 21 or greater than 40\n\n v. AST \\> 5X upper limit of normal for lab\n\n vi. ALT \\> 5X upper limit of normal for lab'}, 'identificationModule': {'nctId': 'NCT01387932', 'acronym': 'HiQuality', 'briefTitle': 'HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merit Medical Systems, Inc.'}, 'officialTitle': 'Phase 3 Prospective, Randomized, Blinded, and Controlled Investigation of HepaSphere/QuadraSphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'HCC-P3-11-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HepaSphere/QuadraSphere TACE', 'description': 'HepaSphere/QuadraSphere TACE', 'interventionNames': ['Device: HepaSphere/QuadraSphere Microspheres']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional TACE', 'description': 'Conventional TACE', 'interventionNames': ['Procedure: PVA, lipiodol, doxorubicin']}], 'interventions': [{'name': 'HepaSphere/QuadraSphere Microspheres', 'type': 'DEVICE', 'description': 'HepaSphere/QuadraSphere Microspheres loaded with doxorubicin', 'armGroupLabels': ['HepaSphere/QuadraSphere TACE']}, {'name': 'PVA, lipiodol, doxorubicin', 'type': 'PROCEDURE', 'description': 'Conventional TACE procedure using PVA, lipiodol and doxorubicin', 'armGroupLabels': ['Conventional TACE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85711', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tuscon Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Greater Arkansas Veterans Healthcare', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Palo Alto Veterans Institute for Research', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '35209', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Albert Einstein Healthcare', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'VA Pittsburgh Healthcare System', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'MUSC Medical Center (Medical University of South Carolina)', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Health and Science Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals K.U. Leuven (Dept of Hematology)', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hospital Saint Andre', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '94804', 'city': 'Villejuif', 'country': 'France', 'facility': 'Hospital Paul Brousse', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '115 28', 'city': 'Athens', 'country': 'Greece', 'facility': 'Evgenidion University Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '12100', 'city': 'Cuneo', 'country': 'Italy', 'facility': 'S. Croce e Carle Hospital', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}], 'overallOfficials': [{'name': 'Michael Soulen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Riccardo Lencioni, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Independent Radiology Panel'}, {'name': 'Josep Llovet, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Data Safety Monitoring Board'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merit Medical Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}