Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-06 @ 7:47 AM
Study NCT ID:
NCT02117934
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2014-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006505', 'term': 'Hepatitis'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017325', 'term': 'Hepatitis B Vaccines'}, {'id': 'C000726347', 'term': 'Heplisav-B'}, {'id': 'C075654', 'term': 'Engerix-B'}], 'ancestors': [{'id': 'D014761', 'term': 'Viral Hepatitis Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '510-848-5100', 'title': 'Robert Janssen MD \\ VP & Chief Medical Officer', 'organization': 'Dynavax Technologies, Inc.'}, 'certainAgreement': {'otherDetails': 'Principal Investigator may communicate study results with prior written consent from Dynavax.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through Week 56', 'description': 'Adverse Events were assessed for the Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data.', 'eventGroups': [{'id': 'EG000', 'title': 'HEPLISAV', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)\n\nHEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24', 'otherNumAtRisk': 5587, 'otherNumAffected': 1097, 'seriousNumAtRisk': 5587, 'seriousNumAffected': 345}, {'id': 'EG001', 'title': 'Engerix-B', 'description': '1.0 mL Engerix-B\n\nEngerix-B: Intramuscular injections at Week 0, Week 4, and Week 24', 'otherNumAtRisk': 2781, 'otherNumAffected': 549, 'seriousNumAtRisk': 2781, 'seriousNumAffected': 148}], 'otherEvents': [{'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 174}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 102}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 149}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 84}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 191}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 92}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 63}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 54}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 54}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 37}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 57}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anaemia vitamin b12 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': "Ebstein's anomaly", 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sickle cell anaemia with crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': "Pituitary-dependent cushing's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Appendix disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cyclic vomiting syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastritis alcoholic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastritis alcoholic haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastritis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Gastrointestinal 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bladder disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dysfunctional uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diaphragmatic paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diaphragmatic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hidradenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Victim of homicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5587, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2781, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5587', 'groupId': 'OG000'}, {'value': '2781', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HEPLISAV', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)\n\nHEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24'}, {'id': 'OG001', 'title': 'Engerix-B', 'description': '1.0 mL Engerix-B\n\nEngerix-B: Intramuscular injections at Week 0, Week 4, and Week 24'}], 'classes': [{'title': 'New-onset Immune-mediated Adverse Events', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Medically-attended Adverse Events', 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 56', 'description': "The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '640', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HEPLISAV', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)\n\nHEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24'}, {'id': 'OG001', 'title': 'Engerix-B', 'description': '1.0 mL Engerix-B\n\nEngerix-B: Intramuscular injections at Week 0, Week 4, and Week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '87.4', 'upperLimit': '92.2'}, {'value': '65.1', 'groupId': 'OG001', 'lowerLimit': '59.6', 'upperLimit': '70.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 28', 'description': 'Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Diabetes Population:Randomized subjects with type 2 diabetes mellitus (clinical diagnosis of T2DM taking at least oral or non-insulin injectable hypoglycemic agent and/or insulin) who received all study injections, had no major protocol deviations, and had anti-HBs levels obtained within the study visit window at Week 28.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HEPLISAV', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)\n\nHEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24'}, {'id': 'FG001', 'title': 'Engerix-B', 'description': '1.0 mL Engerix-B\n\nEngerix-B: Intramuscular injections at Week 0, Week 4, and Week 24'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5592'}, {'groupId': 'FG001', 'numSubjects': '2782'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5092'}, {'groupId': 'FG001', 'numSubjects': '2567'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}, {'groupId': 'FG001', 'numSubjects': '215'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5587', 'groupId': 'BG000'}, {'value': '2781', 'groupId': 'BG001'}, {'value': '8368', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HEPLISAV', 'description': '0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)\n\nHEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24'}, {'id': 'BG001', 'title': 'Engerix-B', 'description': '1.0 mL Engerix-B\n\nEngerix-B: Intramuscular injections at Week 0, Week 4, and Week 24'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age ≥ 18 to ≤ 39 years', 'categories': [{'measurements': [{'value': '1132', 'groupId': 'BG000'}, {'value': '561', 'groupId': 'BG001'}, {'value': '1693', 'groupId': 'BG002'}]}]}, {'title': 'Age ≥ 40 years', 'categories': [{'measurements': [{'value': '4455', 'groupId': 'BG000'}, {'value': '2220', 'groupId': 'BG001'}, {'value': '6675', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2743', 'groupId': 'BG000'}, {'value': '1390', 'groupId': 'BG001'}, {'value': '4133', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2844', 'groupId': 'BG000'}, {'value': '1391', 'groupId': 'BG001'}, {'value': '4235', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5587', 'groupId': 'BG000'}, {'value': '2781', 'groupId': 'BG001'}, {'value': '8368', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population: All subjects who received at least 1 study injection and who had any post-baseline safety data'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8374}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'dispFirstSubmitDate': '2017-02-06', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2014-04-15', 'dispFirstSubmitQcDate': '2017-02-06', 'resultsFirstSubmitDate': '2017-12-08', 'studyFirstSubmitQcDate': '2014-04-17', 'dispFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-08', 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest', 'timeFrame': 'Week 56', 'description': "The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology."}, {'measure': 'Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response', 'timeFrame': 'Week 28', 'description': 'Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HBV vaccine', 'HEPLISAV-B', 'Hepatitis B vaccine', 'Hepatitis B', 'Hepatitis', 'Hepatitis B virus (HBV)', 'Prevention and Control', 'Healthy', 'Healthy volunteers'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '31431412', 'type': 'DERIVED', 'citation': 'Hyer RN, Janssen RS. Immunogenicity and safety of a 2-dose hepatitis B vaccine, HBsAg/CpG 1018, in persons with diabetes mellitus aged 60-70 years. Vaccine. 2019 Sep 16;37(39):5854-5861. doi: 10.1016/j.vaccine.2019.08.005. Epub 2019 Aug 17.'}, {'pmid': '29289383', 'type': 'DERIVED', 'citation': 'Jackson S, Lentino J, Kopp J, Murray L, Ellison W, Rhee M, Shockey G, Akella L, Erby K, Heyward WL, Janssen RS; HBV-23 Study Group. Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults. Vaccine. 2018 Jan 29;36(5):668-674. doi: 10.1016/j.vaccine.2017.12.038. Epub 2017 Dec 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and immunogenicity of an investigational hepatitis B vaccine (HEPLISAV) in adults 18 to 70 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "A subject must meet all of the following criteria to be eligible for the trial:\n\nInclusion Criteria:\n\n* Be 18-70 years of age, inclusive\n* Able to comprehend and follow all required study procedures and be available for all visits scheduled in the study\n* If a woman is of childbearing potential, she must consistently use an acceptable method of contraception or confirm in writing she will abstain from sexual activity from the Screening Visit through Week 28.\n* Able and willing to provide informed consent\n\nA subject with any one of the following criteria is not eligible for the trial:\n\nExclusion Criteria:\n\n* Previous receipt of any hepatitis B vaccine\n* History of hepatitis B or human immunodeficiency virus (HIV) infection or positive test for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), or antibody to HIV\n* History of autoimmune disorder\n* History of sensitivity to any component of study vaccines\n* Has received the following prior to the first injection:\n\n 1. Within 28 days:\n\n * Any vaccine\n * Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication\n * Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)\n * Any other investigational medicinal agent\n 2. Within 90 days: Blood products or immunoglobulin\n 3. At any time: An injection of DNA plasmids or oligonucleotide\n* If female: Pregnant, nursing, or planning to become pregnant during the trial\n* Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin\n* Any other medical condition considered by the investigator likely to interfere with the subject's compliance or the interpretation of study assessments"}, 'identificationModule': {'nctId': 'NCT02117934', 'briefTitle': 'Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dynavax Technologies Corporation'}, 'officialTitle': 'A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age', 'orgStudyIdInfo': {'id': 'DV2-HBV-23'}}, 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['HEPLISAV']}, {'name': 'Engerix-B', 'type': 'BIOLOGICAL', 'otherNames': ['Hepatitis B vaccine (recombinant)'], 'description': 'Intramuscular injections at Week 0, Week 4, and Week 24', 'armGroupLabels': ['Engerix-B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Advantage, Inc.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Advantage, Inc.', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Advantage, Inc.', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': 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