Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT00119067
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2005-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000881', 'term': 'Anthrax'}], 'ancestors': [{'id': 'D016863', 'term': 'Bacillaceae Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022122', 'term': 'Anthrax Vaccines'}, {'id': 'C493276', 'term': 'Biothrax'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jgwright@cdc.gov', 'title': 'Jennifer G Wright', 'organization': 'CDC'}, 'certainAgreement': {'otherDetails': 'PIs must have the approval of all 5 PIs to conduct and publish additional research using clinical trial data or specimens', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was not statistically powered to identify very rare SAEs.'}}, 'adverseEventsModule': {'timeFrame': 'The observation period for Solicited AEs and Other AEs was 14 days post-injection for the first two injections, and 28 days for all subsequent injections. Serious Adverse Event (SAE) data were collected and reported to FDA as they occurred.', 'description': 'Adverse Event data were collected for each injection during scheduled office visits and by patient reporting via a diary.', 'eventGroups': [{'id': 'EG000', 'title': '8-SQ', 'description': '8 AVA injections administered subcutaneously at months 0, 0.5, 1, 6, 12, 18, 30, and 42 (the initially licensed schedule and route)', 'otherNumAtRisk': 259, 'deathsNumAtRisk': 259, 'otherNumAffected': 254, 'seriousNumAtRisk': 259, 'deathsNumAffected': 0, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': '8-IM', 'description': '8 AVA injections administered intramuscularly at months 0, 0.5, 1, 6, 12, 18, 30, and 42', 'otherNumAtRisk': 262, 'deathsNumAtRisk': 262, 'otherNumAffected': 250, 'seriousNumAtRisk': 262, 'deathsNumAffected': 3, 'seriousNumAffected': 35}, {'id': 'EG002', 'title': '7-IM', 'description': '7 AVA injections administered intramuscularly at months 0, 1, 6, 12, 18, 30, and 42', 'otherNumAtRisk': 256, 'deathsNumAtRisk': 256, 'otherNumAffected': 249, 'seriousNumAtRisk': 256, 'deathsNumAffected': 2, 'seriousNumAffected': 27}, {'id': 'EG003', 'title': '5-IM AVA', 'description': '5 AVA injections administered intramuscularly at months 0, 1, 6, 18, and 42', 'otherNumAtRisk': 258, 'deathsNumAtRisk': 258, 'otherNumAffected': 253, 'seriousNumAtRisk': 258, 'deathsNumAffected': 1, 'seriousNumAffected': 35}, {'id': 'EG004', 'title': '4-IM', 'description': '4 AVA injections administered intramuscularly at months 0, 1, 6, and 42', 'otherNumAtRisk': 268, 'deathsNumAtRisk': 268, 'otherNumAffected': 263, 'seriousNumAtRisk': 268, 'deathsNumAffected': 0, 'seriousNumAffected': 38}, {'id': 'EG005', 'title': 'Saline Placebo', 'description': '8 saline placebo injections administered subcutaneously or intramuscularly at months 0, 0.5, 1, 6, 12, 18, 30, and 42. Placebo participants were grouped for analysis regardless of injection route', 'otherNumAtRisk': 260, 'deathsNumAtRisk': 260, 'otherNumAffected': 200, 'seriousNumAtRisk': 260, 'deathsNumAffected': 1, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'LYMPHADENOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ABDOMINAL PAIN NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DIARRHOEA NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 25}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 36}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VOMITING NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 199}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 187}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 187}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 177}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 181}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 158}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INJECTION SITE BRUISING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 150}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 101}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 85}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 101}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 80}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 74}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 244}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 209}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 207}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 187}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 195}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 137}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INJECTION SITE JOINT MOVEMENT IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 163}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 179}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 177}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 176}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 188}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 226}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 223}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 224}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 221}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 222}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 84}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INJECTION SITE PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 186}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 114}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 101}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 71}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 73}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INJECTION SITE SWELLING / LUMP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 248}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 215}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 218}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 200}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 184}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 120}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INJECTION SITE TENDERNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 251}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 241}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 243}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 237}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 244}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 110}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INJECTION SITE WARMTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 223}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 154}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 140}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 122}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 106}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPERSENSITIVITY NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 9}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 58}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 59}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 62}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 56}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SINUSITIS NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 30}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 34}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 25}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'URINARY TRACT INFECTION NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'JOINT SPRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'LIMB INJURY NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'POST PROCEDURAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 21}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPERCHOLESTEROLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 50}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 52}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 44}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 42}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 43}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 51}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 38}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MUSCULOSKELETAL STIFFNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 197}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 185}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 188}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 186}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 195}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 130}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NECK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 28}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 203}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 173}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 194}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 181}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 187}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 177}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DYSMENORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 30}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 25}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BRONCHITIS NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 35}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NASAL CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PHARYNGOLARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 53}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 47}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 37}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RESPIRATORY TRACT CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RHINITIS NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SINUS CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DERMATITIS CONTACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RASH NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPERTENSION NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 262, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 256, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 258, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 268, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 260, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Death due to atherosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'muscle, tendon, or ligament tear/rupture', 'notes': 'Due to falls, accidents, or non-specified reasons', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Generalized allergic reaction', 'notes': 'Generalized allergic reaction (note:\n\nContac Nighttime medicine was also temporally associated with some of the allergic symptoms. These symptoms reoccurred following a second exposure to Contac Nighttime medicine)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bilateral pseudotumor cerebri', 'notes': 'occurred with bilateral disc edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hydrocephalus and aqueductal stenosis', 'notes': 'new onset of seizure led to diagnosis of hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumocystis carinii', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Hodgkin's Lymphoma", 'notes': 'stage 1A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Basal Cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'pancreatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'cellulitis, hospitalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Embolization secondary to AV malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'burns', 'notes': 'following a fire', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'appendectomy secondary to appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Systemic Lupus Erythematosus/positive ANA', 'notes': 'and lupus related disease', 'stats': [{'groupId': 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260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'hip arthroplasty', 'notes': 'due to avascular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'prostatectomy', 'notes': 'to remove prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'gastroesophageal reflux leading to abnormal EKG and chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HIV positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'hospitalized; chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'hospitalized, back pain evaluation', 'notes': 'no diagnosis provided', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ventriculostomy', 'notes': 'for aqueductal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'transient ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'benign ovarian cysts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leiomyomata', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'hysterectomy plus oophorectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'multiple injuries following motor vehicle accident', 'notes': 'to include fractures, coma, and cardiac arrest. Patient ultimately survived injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 259, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 260, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Local AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '958', 'groupId': 'OG000'}, {'value': '2806', 'groupId': 'OG001'}, {'value': '835', 'groupId': 'OG002'}, {'value': '2584', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SQ Females', 'description': 'female participants receiving SQ AVA injection'}, {'id': 'OG001', 'title': 'IM Female', 'description': 'female participants receiving IM AVA injection'}, {'id': 'OG002', 'title': 'SQ Males', 'description': 'male participants receiving SQ AVA injection'}, {'id': 'OG003', 'title': 'IM Male', 'description': 'male participants receiving IM AVA injection'}], 'classes': [{'title': 'Warmth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '952', 'groupId': 'OG000'}, {'value': '2772', 'groupId': 'OG001'}, {'value': '827', 'groupId': 'OG002'}, {'value': '2556', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '500', 'groupId': 'OG000'}, {'value': '344', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}, {'value': '189', 'groupId': 'OG003'}]}]}, {'title': 'Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '952', 'groupId': 'OG000'}, {'value': '2806', 'groupId': 'OG001'}, {'value': '832', 'groupId': 'OG002'}, {'value': '2584', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '667', 'groupId': 'OG000'}, {'value': '1398', 'groupId': 'OG001'}, {'value': '410', 'groupId': 'OG002'}, {'value': '1075', 'groupId': 'OG003'}]}]}, {'title': 'Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '946', 'groupId': 'OG000'}, {'value': '2762', 'groupId': 'OG001'}, {'value': '824', 'groupId': 'OG002'}, {'value': '2551', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}, {'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '942', 'groupId': 'OG000'}, {'value': '2780', 'groupId': 'OG001'}, {'value': '826', 'groupId': 'OG002'}, {'value': '2561', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '569', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '341', 'groupId': 'OG003'}]}]}, {'title': 'Arm Motion Limitation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '943', 'groupId': 'OG000'}, {'value': '2771', 'groupId': 'OG001'}, {'value': '822', 'groupId': 'OG002'}, {'value': '2558', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '218', 'groupId': 'OG003'}]}]}, {'title': 'Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '958', 'groupId': 'OG000'}, {'value': '2791', 'groupId': 'OG001'}, {'value': '835', 'groupId': 'OG002'}, {'value': '2565', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '723', 'groupId': 'OG000'}, {'value': '952', 'groupId': 'OG001'}, {'value': '399', 'groupId': 'OG002'}, {'value': '603', 'groupId': 'OG003'}]}]}, {'title': 'Induration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '946', 'groupId': 'OG000'}, {'value': '2772', 'groupId': 'OG001'}, {'value': '830', 'groupId': 'OG002'}, {'value': '2555', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '411', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}, {'value': '245', 'groupId': 'OG003'}]}]}, {'title': 'Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '948', 'groupId': 'OG000'}, {'value': '2772', 'groupId': 'OG001'}, {'value': '827', 'groupId': 'OG002'}, {'value': '2558', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '345', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '225', 'groupId': 'OG002'}, {'value': '354', 'groupId': 'OG003'}]}]}, {'title': 'Nodules', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '947', 'groupId': 'OG000'}, {'value': '2762', 'groupId': 'OG001'}, {'value': '825', 'groupId': 'OG002'}, {'value': '2554', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '409', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}]}, {'title': 'Bruise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '942', 'groupId': 'OG000'}, {'value': '2764', 'groupId': 'OG001'}, {'value': '822', 'groupId': 'OG002'}, {'value': '2552', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after each injection', 'description': 'warmth, tenderness, itching, pain, arm motion limitation, erythema, induration, nodule, and bruise.\n\nThe number of injections analyzable varies for each event based on the presence or absence of reported data.', 'unitOfMeasure': 'injections', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of doses received', 'denomUnitsSelected': 'Number of doses received', 'populationDescription': 'There are missing data'}, {'type': 'PRIMARY', 'title': 'Systemic AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '958', 'groupId': 'OG000'}, {'value': '2806', 'groupId': 'OG001'}, {'value': '835', 'groupId': 'OG002'}, {'value': '2584', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SQ Females', 'description': 'female participants receiving SQ AVA injection'}, {'id': 'OG001', 'title': 'IM Female', 'description': 'female participants receiving IM AVA injection'}, {'id': 'OG002', 'title': 'SQ Males', 'description': 'male participants receiving SQ AVA injection'}, {'id': 'OG003', 'title': 'IM Male', 'description': 'male participants receiving IM AVA injection'}], 'classes': [{'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '942', 'groupId': 'OG000'}, {'value': '2768', 'groupId': 'OG001'}, {'value': '825', 'groupId': 'OG002'}, {'value': '2564', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '278', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '182', 'groupId': 'OG003'}]}]}, {'title': 'Muscle Ache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '942', 'groupId': 'OG000'}, {'value': '2769', 'groupId': 'OG001'}, {'value': '825', 'groupId': 'OG002'}, {'value': '2558', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '132', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '942', 'groupId': 'OG000'}, {'value': '2767', 'groupId': 'OG001'}, {'value': '823', 'groupId': 'OG002'}, {'value': '2559', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}]}, {'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '937', 'groupId': 'OG000'}, {'value': '2745', 'groupId': 'OG001'}, {'value': '822', 'groupId': 'OG002'}, {'value': '2546', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Tender Axillary Adenopathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '510', 'groupId': 'OG003'}]}, {'units': 'Number of doses received', 'counts': [{'value': '939', 'groupId': 'OG000'}, {'value': '2762', 'groupId': 'OG001'}, {'value': '823', 'groupId': 'OG002'}, {'value': '2553', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after each injection', 'description': 'Fatigue, Muscle Ache, Headache, Fever, Tender Axillary Lymphnode The number of injections analyzable varies for each event based on the presence or absence of reported data.', 'unitOfMeasure': 'injections', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of doses received', 'denomUnitsSelected': 'Number of doses received', 'populationDescription': 'We analyzed by number of doses received. There might be missing data; people dropped out as time went on'}, {'type': 'PRIMARY', 'title': 'Anti-protective Antigen IgG Geometric Mean Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}, {'value': '157', 'groupId': 'OG004'}, {'value': '698', 'groupId': 'OG005'}, {'value': '243', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Anthrax Vaccine Adsorbed 8-SQ', 'description': 'receive 8 injections of AVA injected SQ at the same points as the original licensure: 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG001', 'title': 'Anthrax Vaccine Adsorbed 8-IM', 'description': 'receive 8 injections of AVA IM administered at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG002', 'title': 'Anthrax Vaccine Adsorbed 7-IM', 'description': 'receive 7 injections of AVA IM administered at 0m, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG003', 'title': 'Anthrax Vaccine Adsorbed 5-IM', 'description': 'receive 5 injections of AVA IM administered at 0m, 1m, 6m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG004', 'title': 'Anthrax Vaccine Adsorbed 4-IM', 'description': 'receive 4 injections of AVA IM; 0m, 1m, 6m and a booster at 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG005', 'title': 'Anthrax Vaccine Adsorbed 754-IM', 'description': 'The 7-IM, 5-IM, and 4-IM arms received the same 0, 1, 6 month primary series schedule, so were combined for analysis at months 2 and 7. Analysis at month 43 was done separately since the schedules differed at that time. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.'}, {'id': 'OG006', 'title': 'Saline Placebo IM or SQ', 'description': 'Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.'}], 'classes': [{'title': 'Month 2', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000', 'lowerLimit': '82.1', 'upperLimit': '108.3'}, {'value': '84.5', 'groupId': 'OG001', 'lowerLimit': '73.7', 'upperLimit': '96.8'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '46.4', 'groupId': 'OG005', 'lowerLimit': '42.2', 'upperLimit': '51.0'}, {'value': '1.9', 'groupId': 'OG006', 'lowerLimit': '1.9', 'upperLimit': '2.0'}]}]}, {'title': 'Month 7', 'categories': [{'measurements': [{'value': '201.1', 'groupId': 'OG000', 'lowerLimit': '174.7', 'upperLimit': '231.6'}, {'value': '232.6', 'groupId': 'OG001', 'lowerLimit': '202.4', 'upperLimit': '267.3'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '206.9', 'groupId': 'OG005', 'lowerLimit': '187.1', 'upperLimit': '227.0'}, {'value': '1.9', 'groupId': 'OG006', 'lowerLimit': '1.9', 'upperLimit': '2.0'}]}]}, {'title': 'Month 43', 'categories': [{'measurements': [{'value': '216.8', 'groupId': 'OG000', 'lowerLimit': '185.8', 'upperLimit': '253.1'}, {'value': '320.5', 'groupId': 'OG001', 'lowerLimit': '276.0', 'upperLimit': '372.1'}, {'value': '254.8', 'groupId': 'OG002', 'lowerLimit': '222.0', 'upperLimit': '292.4'}, {'value': '310.0', 'groupId': 'OG003', 'lowerLimit': '270.5', 'upperLimit': '355.3'}, {'value': '433.2', 'groupId': 'OG004', 'lowerLimit': '379.6', 'upperLimit': '494.4'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.9', 'groupId': 'OG006', 'lowerLimit': '1.8', 'upperLimit': '1.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks after the m1, m6 and m42 injections', 'description': 'Geometric mean of the Anti-PA IgG Concentration measured in μg/mL. The lower limit of quantification (LLOQ) is 3.7, results below the LLOQ have been replaced by 1/2 LLOQ (1.85) before taking the geometric mean.', 'unitOfMeasure': 'μg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'TNA ED50 Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}, {'value': '315', 'groupId': 'OG005'}, {'value': '124', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Anthrax Vaccine Adsorbed 8-SQ', 'description': 'receive 8 injections of AVA injected SQ at the same points as the original licensure: 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG001', 'title': 'Anthrax Vaccine Adsorbed 8-IM', 'description': 'receive 8 injections of AVA IM administered at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG002', 'title': 'Anthrax Vaccine Adsorbed 7-IM', 'description': 'receive 7 injections of AVA IM administered at 0m, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG003', 'title': 'Anthrax Vaccine Adsorbed 5-IM', 'description': 'receive 5 injections of AVA IM administered at 0m, 1m, 6m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG004', 'title': 'Anthrax Vaccine Adsorbed 4-IM', 'description': 'receive 4 injections of AVA IM; months 0, 2, 6 and a booster at month 42\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG005', 'title': 'Anthrax Vaccine Adsorbed 754-IM', 'description': 'The 7-IM, 5-IM, and 4-IM arms received the same 0, 1, 6 month primary series schedule, so were combined for analysis at months 2 and 7. Analysis at month 43 was done separately since the schedules differed at that time. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.'}, {'id': 'OG006', 'title': 'Saline Placebo IM or SQ', 'description': 'Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.'}], 'classes': [{'title': 'Month 2', 'categories': [{'measurements': [{'value': '229.1', 'groupId': 'OG000', 'lowerLimit': '190.9', 'upperLimit': '274.9'}, {'value': '240.8', 'groupId': 'OG001', 'lowerLimit': '196.5', 'upperLimit': '295.2'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '165.5', 'groupId': 'OG005', 'lowerLimit': '146.2', 'upperLimit': '187.4'}, {'value': '18.0', 'groupId': 'OG006', 'lowerLimit': '18.0', 'upperLimit': '18.0'}]}]}, {'title': 'Month 7', 'categories': [{'measurements': [{'value': '1281.1', 'groupId': 'OG000', 'lowerLimit': '1073.9', 'upperLimit': '1528.3'}, {'value': '1630.0', 'groupId': 'OG001', 'lowerLimit': '1354.3', 'upperLimit': '1961.7'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1423.9', 'groupId': 'OG005', 'lowerLimit': '1253.1', 'upperLimit': '1617.9'}, {'value': '18.1', 'groupId': 'OG006', 'lowerLimit': '17.9', 'upperLimit': '18.4'}]}]}, {'title': 'Month 43', 'categories': [{'measurements': [{'value': '1015.0', 'groupId': 'OG000', 'lowerLimit': '827.8', 'upperLimit': '1244.4'}, {'value': '1540.3', 'groupId': 'OG001', 'lowerLimit': '1274.6', 'upperLimit': '1861.4'}, {'value': '1451.0', 'groupId': 'OG002', 'lowerLimit': '1139.5', 'upperLimit': '1847.7'}, {'value': '1876.2', 'groupId': 'OG003', 'lowerLimit': '1603.1', 'upperLimit': '2195.9'}, {'value': '2825.9', 'groupId': 'OG004', 'lowerLimit': '2175.2', 'upperLimit': '3671.3'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '18.0', 'groupId': 'OG006', 'lowerLimit': '18.0', 'upperLimit': '18.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks after the m1, m6 and m42 injections', 'description': 'Geometric mean of the ED50. The ED50 is the reciprocal of the dilution at which patient serum neutralizes 50% of a dose of anthrax lethal toxin (ED50). The lower limit of quantification (LLOQ) for this assay is 36, results below the LLOQ have been replaced with 1/2 LLOQ (18) before taking the geometric mean. Note that this secondary endpoint was only performed on \\~47% of the participants.', 'unitOfMeasure': 'ED50 Dilutional Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anti-protective Antigen IgG Geometric Mean Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}, {'value': '157', 'groupId': 'OG004'}, {'value': '698', 'groupId': 'OG005'}, {'value': '243', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Anthrax Vaccine Adsorbed 8-SQ', 'description': 'receive 8 injections of AVA injected SQ at the same points as the original licensure: 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG001', 'title': 'Anthrax Vaccine Adsorbed 8-IM', 'description': 'receive 8 injections of AVA IM administered at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG002', 'title': 'Anthrax Vaccine Adsorbed 7-IM', 'description': 'receive 7 injections of AVA IM administered at 0m, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG003', 'title': 'Anthrax Vaccine Adsorbed 5-IM', 'description': 'receive 5 injections of AVA IM administered at 0m, 1m, 6m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG004', 'title': 'Anthrax Vaccine Adsorbed 4-IM', 'description': 'receive 4 injections of AVA IM; months 0, 2, 6 and a booster at month 42\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG005', 'title': 'Anthrax Vaccine Adsorbed 754-IM', 'description': 'The 7-IM, 5-IM, and 4-IM arms received the same 0, 1, 6 month primary series schedule, so were combined for analysis at months 2 and 7. Analysis at month 43 was done separately since the schedules differed at that time. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.'}, {'id': 'OG006', 'title': 'Saline Placebo IM or SQ', 'description': 'Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.'}], 'classes': [{'title': 'Month 2', 'categories': [{'measurements': [{'value': '1048.5', 'groupId': 'OG000', 'lowerLimit': '913.1', 'upperLimit': '1204.1'}, {'value': '934.8', 'groupId': 'OG001', 'lowerLimit': '815.6', 'upperLimit': '1071.3'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '514.6', 'groupId': 'OG005', 'lowerLimit': '468.1', 'upperLimit': '565.7'}, {'value': '29.7', 'groupId': 'OG006', 'lowerLimit': '28.7', 'upperLimit': '30.6'}]}]}, {'title': 'Month 7', 'categories': [{'measurements': [{'value': '2211.9', 'groupId': 'OG000', 'lowerLimit': '1921.8', 'upperLimit': '2545.9'}, {'value': '2545.6', 'groupId': 'OG001', 'lowerLimit': '2215.1', 'upperLimit': '2925.1'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2257.0', 'groupId': 'OG005', 'lowerLimit': '2050.1', 'upperLimit': '2484.9'}, {'value': '29.7', 'groupId': 'OG006', 'lowerLimit': '28.7', 'upperLimit': '30.8'}]}]}, {'title': 'Month 43', 'categories': [{'measurements': [{'value': '2282.4', 'groupId': 'OG000', 'lowerLimit': '1955.8', 'upperLimit': '2663.5'}, {'value': '3425.4', 'groupId': 'OG001', 'lowerLimit': '2950.4', 'upperLimit': '3976.9'}, {'value': '2760.4', 'groupId': 'OG002', 'lowerLimit': '2404.7', 'upperLimit': '3168.6'}, {'value': '3286.4', 'groupId': 'OG003', 'lowerLimit': '2866.5', 'upperLimit': '3767.8'}, {'value': '4683.8', 'groupId': 'OG004', 'lowerLimit': '4103.0', 'upperLimit': '5346.8'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '29.0', 'groupId': 'OG006', 'lowerLimit': '29.0', 'upperLimit': '29.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '4 weeks after the m1, m6 and m42 injections', 'description': 'Geometric mean of the Dilutional Titer. The Dilutional Titer is the reciprocal of the dilution at which the anti-PA IgG response reaches a threshold. The lower limit of quantification (LLOQ) is 58, results below the LLOQ have been replaced by 1/2 LLOQ (29) before taking the geometric mean.', 'unitOfMeasure': 'Dilutional Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '4-fold Rise in Anti-protective Antigen IgG Titer Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}, {'value': '157', 'groupId': 'OG004'}, {'value': '698', 'groupId': 'OG005'}, {'value': '243', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Anthrax Vaccine Adsorbed 8-SQ', 'description': 'receive 8 injections of AVA injected SQ at the same points as the original licensure: 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG001', 'title': 'Anthrax Vaccine Adsorbed 8-IM', 'description': 'receive 8 injections of AVA IM administered at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG002', 'title': 'Anthrax Vaccine Adsorbed 7-IM', 'description': 'receive 7 injections of AVA IM administered at 0m, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG003', 'title': 'Anthrax Vaccine Adsorbed 5-IM', 'description': 'receive 5 injections of AVA IM administered at 0m, 1m, 6m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG004', 'title': 'Anthrax Vaccine Adsorbed 4-IM', 'description': 'receive 4 injections of AVA IM; months 0, 2, 6 and a booster at month 42\n\nAnthrax Vaccine Adsorbed'}, {'id': 'OG005', 'title': 'Anthrax Vaccine Adsorbed 754-IM', 'description': 'The 7-IM, 5-IM, and 4-IM arms received the same 0, 1, 6 month primary series schedule, so were combined for analysis at months 2 and 7. Analysis at month 43 was done separately since the schedules differed at that time. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.'}, {'id': 'OG006', 'title': 'Saline Placebo IM or SQ', 'description': 'Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.'}], 'classes': [{'title': 'Month 2', 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '91.3', 'upperLimit': '97.3'}, {'value': '91.9', 'groupId': 'OG001', 'lowerLimit': '87.6', 'upperLimit': '95.0'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '78.8', 'groupId': 'OG005', 'lowerLimit': '75.6', 'upperLimit': '81.8'}, {'value': '0.4', 'groupId': 'OG006', 'lowerLimit': '0.01', 'upperLimit': '2.3'}]}]}, {'title': 'Month 7', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.7'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '99.7'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '97.8', 'groupId': 'OG005', 'lowerLimit': '96.3', 'upperLimit': '99.0'}, {'value': '0.5', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Month 43', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '100'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.4', 'upperLimit': '100.0'}, {'value': '99.3', 'groupId': 'OG003', 'lowerLimit': '96.1', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG004', 'lowerLimit': '96.5', 'upperLimit': '100.0'}, {'value': 'NA', 'comment': 'The 7-IM, 5-IM, and 4-IM arms received the same priming schedule, so were combined for analysis at months 2 and 7. The 754-IM arm contains the combined analysis results (months 2 and 7), the individual arms contain the month 43 results.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '2.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after the m1, m6 and m42 injections', 'description': 'Percent of participants who achieved a 4-fold or greater rise in anti-PA IgG Titer relative to the pre-vaccination level at month 0. The Dilutional Titer is the reciprocal of the dilution at which the anti-PA IgG response reaches a threshold. The lower limit of quantification (LLOQ) is 58, results below the LLOQ have been replaced by LLOQ (58) before calculating the fold response. Thus the lowest titer that can achieve 4-fold rise is 4\\*58 = 232.', 'unitOfMeasure': '% of participants with ≥4-fold rise', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anthrax Vaccine Adsorbed 8-SQ', 'description': 'receive 8 injections of AVA injected SQ at the same points as the original licensure: 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'FG001', 'title': 'Anthrax Vaccine Adsorbed 8-IM', 'description': 'receive 8 injections of AVA IM administered at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'FG002', 'title': 'Anthrax Vaccine Adsorbed 7-IM', 'description': 'receive 7 injections of AVA IM administered at 0m, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'FG003', 'title': 'Anthrax Vaccine Adsorbed 5-IM', 'description': 'receive 5 injections of AVA IM administered at 0m, 1m, 6m, and 2 boosters - 30m and 42m.\n\nAnthrax Vaccine Adsorbed'}, {'id': 'FG004', 'title': 'Anthrax Vaccine Adsorbed 4-IM', 'description': 'receive 4 injections of AVA IM; months 0, 2, 6 and a booster at month 42\n\nAnthrax Vaccine Adsorbed'}, {'id': 'FG005', 'title': 'Saline Placebo IM or SQ', 'description': 'Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One person consented and enrolled, then withdrew prior to first vaccination.', 'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '262'}, {'groupId': 'FG002', 'numSubjects': '256'}, {'groupId': 'FG003', 'numSubjects': '258'}, {'groupId': 'FG004', 'numSubjects': '268'}, {'groupId': 'FG005', 'numSubjects': '260'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '157'}, {'groupId': 'FG002', 'numSubjects': '146'}, {'groupId': 'FG003', 'numSubjects': '144'}, {'groupId': 'FG004', 'numSubjects': '158'}, {'groupId': 'FG005', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '105'}, {'groupId': 'FG002', 'numSubjects': '110'}, {'groupId': 'FG003', 'numSubjects': '114'}, {'groupId': 'FG004', 'numSubjects': '110'}, {'groupId': 'FG005', 'numSubjects': '116'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}, {'value': '258', 'groupId': 'BG003'}, {'value': '268', 'groupId': 'BG004'}, {'value': '260', 'groupId': 'BG005'}, {'value': '1563', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Anthrax Vaccine Adsorbed 8-SQ', 'description': 'receive 8 injections of Anthrax Vaccine Adsorbed injected SQ at the same points as the original licensure: 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.'}, {'id': 'BG001', 'title': 'Anthrax Vaccine Adsorbed 8-IM', 'description': 'receive 8 injections of Anthrax Vaccine Adsorbed IM administered at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.'}, {'id': 'BG002', 'title': 'Anthrax Vaccine Adsorbed 7-IM', 'description': 'receive 7 injections of Anthrax Vaccine Adsorbed IM administered at 0m, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.'}, {'id': 'BG003', 'title': 'Anthrax Vaccine Adsorbed 5-IM', 'description': 'receive 5 injections of Anthrax Vaccine Adsorbed IM administered at 0m, 1m, 6m, and 2 boosters - 30m and 42m.'}, {'id': 'BG004', 'title': 'Anthrax Vaccine Adsorbed 4-IM', 'description': 'receive 4 injections of Anthrax Vaccine Adsorbed IM; months 0, 2, 6 and a booster at month 42'}, {'id': 'BG005', 'title': 'Saline Placebo IM or SQ', 'description': 'Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age <30', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}, {'value': '75', 'groupId': 'BG005'}, {'value': '439', 'groupId': 'BG006'}]}]}, {'title': 'Age 30-39', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '361', 'groupId': 'BG006'}]}]}, {'title': 'Age 40-49', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}, {'value': '73', 'groupId': 'BG005'}, {'value': '460', 'groupId': 'BG006'}]}]}, {'title': 'Age 50-61', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}, {'value': '303', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '136', 'groupId': 'BG004'}, {'value': '132', 'groupId': 'BG005'}, {'value': '800', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}, {'value': '132', 'groupId': 'BG004'}, {'value': '128', 'groupId': 'BG005'}, {'value': '763', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race: White', 'categories': [{'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}, {'value': '183', 'groupId': 'BG003'}, {'value': '201', 'groupId': 'BG004'}, {'value': '185', 'groupId': 'BG005'}, {'value': '1159', 'groupId': 'BG006'}]}]}, {'title': 'Race: Black', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}, {'value': '324', 'groupId': 'BG006'}]}]}, {'title': 'Race: Other', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}]}]}, {'title': 'Ethnicity:Non-Hispanic', 'categories': [{'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}, {'value': '243', 'groupId': 'BG003'}, {'value': '256', 'groupId': 'BG004'}, {'value': '251', 'groupId': 'BG005'}, {'value': '1493', 'groupId': 'BG006'}]}]}, {'title': 'Ethnicity: Hispanic', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '70', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'mean study group size was 261 (range 260-268); proportions of men 48.8% to women 51.2% was not statistically different across groups or time points; mean age was 39 years; Whites accounted for 74%, Blacks for 21%, and "other" for 5% of participants; less than 5% of study population was Hispanic'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1564}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2005-07-06', 'resultsFirstSubmitDate': '2014-12-09', 'studyFirstSubmitQcDate': '2005-07-11', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-01', 'studyFirstPostDateStruct': {'date': '2005-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local AEs', 'timeFrame': '4 weeks after each injection', 'description': 'warmth, tenderness, itching, pain, arm motion limitation, erythema, induration, nodule, and bruise.\n\nThe number of injections analyzable varies for each event based on the presence or absence of reported data.'}, {'measure': 'Systemic AEs', 'timeFrame': '4 weeks after each injection', 'description': 'Fatigue, Muscle Ache, Headache, Fever, Tender Axillary Lymphnode The number of injections analyzable varies for each event based on the presence or absence of reported data.'}, {'measure': 'Anti-protective Antigen IgG Geometric Mean Concentration', 'timeFrame': '4 weeks after the m1, m6 and m42 injections', 'description': 'Geometric mean of the Anti-PA IgG Concentration measured in μg/mL. The lower limit of quantification (LLOQ) is 3.7, results below the LLOQ have been replaced by 1/2 LLOQ (1.85) before taking the geometric mean.'}, {'measure': 'Anti-protective Antigen IgG Geometric Mean Titer', 'timeFrame': '4 weeks after the m1, m6 and m42 injections', 'description': 'Geometric mean of the Dilutional Titer. The Dilutional Titer is the reciprocal of the dilution at which the anti-PA IgG response reaches a threshold. The lower limit of quantification (LLOQ) is 58, results below the LLOQ have been replaced by 1/2 LLOQ (29) before taking the geometric mean.'}, {'measure': '4-fold Rise in Anti-protective Antigen IgG Titer Response', 'timeFrame': '4 weeks after the m1, m6 and m42 injections', 'description': 'Percent of participants who achieved a 4-fold or greater rise in anti-PA IgG Titer relative to the pre-vaccination level at month 0. The Dilutional Titer is the reciprocal of the dilution at which the anti-PA IgG response reaches a threshold. The lower limit of quantification (LLOQ) is 58, results below the LLOQ have been replaced by LLOQ (58) before calculating the fold response. Thus the lowest titer that can achieve 4-fold rise is 4\\*58 = 232.'}], 'secondaryOutcomes': [{'measure': 'TNA ED50 Titer', 'timeFrame': '4 weeks after the m1, m6 and m42 injections', 'description': 'Geometric mean of the ED50. The ED50 is the reciprocal of the dilution at which patient serum neutralizes 50% of a dose of anthrax lethal toxin (ED50). The lower limit of quantification (LLOQ) for this assay is 36, results below the LLOQ have been replaced with 1/2 LLOQ (18) before taking the geometric mean. Note that this secondary endpoint was only performed on \\~47% of the participants.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anthrax', 'Vaccine', 'Immunogenicity', 'Reactogenicity'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '18827210', 'type': 'BACKGROUND', 'citation': 'Marano N, Plikaytis BD, Martin SW, Rose C, Semenova VA, Martin SK, Freeman AE, Li H, Mulligan MJ, Parker SD, Babcock J, Keitel W, El Sahly H, Poland GA, Jacobson RM, Keyserling HL, Soroka SD, Fox SP, Stamper JL, McNeil MM, Perkins BA, Messonnier N, Quinn CP; Anthrax Vaccine Research Program Working Group. Effects of a reduced dose schedule and intramuscular administration of anthrax vaccine adsorbed on immunogenicity and safety at 7 months: a randomized trial. JAMA. 2008 Oct 1;300(13):1532-43. doi: 10.1001/jama.300.13.1532.'}, {'pmid': '24373307', 'type': 'RESULT', 'citation': 'Wright JG, Plikaytis BD, Rose CE, Parker SD, Babcock J, Keitel W, El Sahly H, Poland GA, Jacobson RM, Keyserling HL, Semenova VA, Li H, Schiffer J, Dababneh H, Martin SK, Martin SW, Marano N, Messonnier NE, Quinn CP. Effect of reduced dose schedules and intramuscular injection of anthrax vaccine adsorbed on immunological response and safety profile: a randomized trial. Vaccine. 2014 Feb 12;32(8):1019-28. doi: 10.1016/j.vaccine.2013.10.039. Epub 2013 Dec 25.'}, {'pmid': '26865594', 'type': 'DERIVED', 'citation': 'Quinn CP, Sabourin CL, Schiffer JM, Niemuth NA, Semenova VA, Li H, Rudge TL, Brys AM, Mittler RS, Ibegbu CC, Wrammert J, Ahmed R, Parker SD, Babcock J, Keitel W, Poland GA, Keyserling HL, El Sahly H, Jacobson RM, Marano N, Plikaytis BD, Wright JG. Humoral and Cell-Mediated Immune Responses to Alternate Booster Schedules of Anthrax Vaccine Adsorbed in Humans. Clin Vaccine Immunol. 2016 Apr 4;23(4):326-38. doi: 10.1128/CVI.00696-15. Print 2016 Apr.'}, {'pmid': '23741398', 'type': 'DERIVED', 'citation': 'Falola MI, Wiener HW, Wineinger NE, Cutter GR, Kimberly RP, Edberg JC, Arnett DK, Kaslow RA, Tang J, Shrestha S. Genomic copy number variants: evidence for association with antibody response to anthrax vaccine adsorbed. PLoS One. 2013 May 31;8(5):e64813. doi: 10.1371/journal.pone.0064813. Print 2013.'}, {'pmid': '21368772', 'type': 'DERIVED', 'citation': 'Pajewski NM, Parker SD, Poland GA, Ovsyannikova IG, Song W, Zhang K, McKinney BA, Pankratz VS, Edberg JC, Kimberly RP, Jacobson RM, Tang J, Kaslow RA. The role of HLA-DR-DQ haplotypes in variable antibody responses to anthrax vaccine adsorbed. Genes Immun. 2011 Sep;12(6):457-65. doi: 10.1038/gene.2011.15. Epub 2011 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'Anthrax Clinical Trial Objectives:\n\nTo assess whether:\n\n* Anthrax vaccine (AVA or BioThrax, BioPort Corp. Lansing MI) administered by the intramuscular (IM) route elicits antibody responses that are not inferior (i.e., "non-inferior") to that achieved by the currently licensed schedule.\n* BioThrax administered by the IM route and containing fewer numbers of doses elicits antibody responses that are not inferior (i.e., "non-inferior") to that achieved by the currently licensed schedule.\n* Differences in reactogenicity exist between the IM and subcutaneous (SQ) administration of BioThrax.\n\nAdditionally for the final report we will assess whether:\n\n* Occurrence of adverse events following AVA administration is influenced by selected risk factors.', 'detailedDescription': "This study is a 43-month prospective, randomized, double-blind, placebo-controlled comparison of immunogenicity and reactogenicity elicited by BioThrax given by different routes of administration (SQ versus IM) and dosing regimens (as many as 8 doses versus as few as 4 doses). Sterile saline is used as the placebo where doses are dropped in regimens using AVA, and in the all-placebo study group.\n\nThis study is conducted among a total of 1564 healthy adult men and women (18 to 61 years of age) at five sites in the United States. Participants were randomized into one of 6 study groups with 260 participants per group. One group receives BioThrax given as currently licensed (SQ with 6 doses followed by annual boosters); another group is given placebo IM (130 participants) or SQ (130 participants) in the currently licensed dosing regimen. The four other groups receive BioThrax IM in modified dosing regimens; placebo is given when a dose of BioThrax is omitted from the licensed dosing regimen. There are a total of 25 required visits for this study, during which all participants receive an injection of vaccine or placebo (8 injections total), have a blood sample drawn (16 or 17 total), and have an in-clinic examination for adverse events (22 total).\n\nImmunogenicity is assessed by assaying 16 serial blood samples obtained from all participants and a 17th sample from a subset of participants before vaccination and at other specified times. Total anti-protective antigen IgG antibody (anti-PA IgG) is quantified using a standardized and validated enzyme-linked immunosorbent assay (ELISA); the primary study endpoints are 4-fold rise in antibody titer and antibody concentration relative to the pre-vaccination titers or assay reactivity threshold. A subset of serum samples is also assayed in an in vitro toxin neutralization assay (TNA) to measure the functional activity of anti-BioThrax antibodies. The kinetics of the immune response to BioThrax are examined at 3 time points in the study and blood samples from a subset of participants will be further tested in correlates of protection and immunogenetics substudies. All adverse events (AEs), including vaccine reactogenicity, are actively monitored. While all AEs will be ascertained among study participants, several endpoints will be defined based on the likelihood of their occurrence and/or their clinical importance. Of primary interest is the occurrence of local AEs such as warmth, tenderness, itching, pain, arm motion limitation, erythema, induration, nodule, and bruise. Systemic AEs such as fever, fatigue, muscle ache, headache, temperature, and painful axillary adenopathy are also evaluated.\n\nThis study is expected to provide the basis for consideration of change in route of BioThrax administration from SQ to IM and reduction in number of vaccine doses required for primary and booster immunization.\n\nThere is an interim analysis of data collected through each participant's first 7 months of this study for consideration in changing the route of BioThrax administration from SQ to IM, and elimination of the 2 week vaccine priming dose.\n\nAt the end of the study, the Sponsor will present the entire results of the trial to FDA for consideration in elimination of additional doses from the licensed BioThrax schedule. At that time, the Sponsor will also supplement these data with results from parallel non-human primate challenge studies and additional research on immunologic correlates of protection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '61 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRead/sign Informed Consent Document; Female or male, 18 to 61 years old (up to 62nd birthday); Females must agree to exercise adequate birth control from the time of the screening procedures to one month after the last vaccination; willingness/ability to return for all follow-up visits and blood collections for the duration of the study; ability to understand/comply with planned study procedures; agree to complete the Participant Diary (Appendix G) and to report concomitant medications and AEs during the study period; thave two intact upper arms with sufficient subcutaneous and intramuscular tissue in the deltoid regions for vaccine administration.Potential participants with a history of the following conditions remain eligible for study enrollment: gestational diabetes; treated, controlled, uncomplicated hypertension; treated hypo- or hyperthyroidism; cured nonmetastatic cancer; disease-free for 5 years (excluding hematologic malignancies); localized skin cancer, resected (including squamous cell and basal cell carcinomas, participants with a history of melanoma must be disease-free for 5 years); exercise-induced bronchospasm; mild asthma: use of inhalers only for control of symptoms is acceptable (Persons who have required hospitalization for asthma within the previous 2 years or those who require chronic or frequent oral/parenteral steroids will not be eligible; use of low to medium doses of inhaled steroids; history of coronary artery disease, asymptomatic (NYHA Function Class I), on a stable medical regimen. Persons meeting these criteria must be at least 2 years post-myocardial infarction, cardiac bypass surgery, and/or percutaneous coronary intervention (e.g., angioplasty, stent placement, etc) in order to qualify. Persons with a history of cardiac disease must be under the care of a physician.\n\nExclusion Criteria:\n\nPrior history of anthrax or immunization against anthrax; Known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex; Pregnant/plans to become pregnant for duration of study/does not agree to use adequate birth control from the time of screening procedures to one month after last vaccination; Used cytotoxic therapy in previous 5 years; Cardiovascular disease with significant likelihood of progression over 5 years; Moderate to severe asthma, chronic obstructive pulmonary disease, other significant pulmonary disease; using high doses of inhaled steroids; Clinically recognized hepatic or renal insufficiency; Inflammatory, vasculitic, or rheumatic disease including systemic lupus erythematosis, polymyalgia rheumatica and rheumatoid arthritis, scleroderma; Known HIV, hepatitis B or hepatitis C infection; Other conditions known to produce or be associated with immune suppression; Neuropathy or other evolving neurologic condition; Unstable/moderate to severe mental illness; Ongoing drug abuse/dependence (including alcohol); Seizure disorder; Active malignancy or history of metastatic or hematologic malignancy; current diabetes; Anyone who plans to receive within 60 days of study entry: cytotoxic therapy, experimental products, a live vaccine outside this trial, immunosuppressive therapy, parenteral immunoglobulin or blood products; Anyone who plans to receive an inactivated vaccine outside this trial within 42 days after study entry;: experimental products, a live vaccine outside this trial, immunosuppressive therapy; Anyone who received an inactivated vaccine outside this trial within 14 days prior to study entry, parenteral immunoglobulin or blood products within three months of study. In addition to conditions listed above, temporary exclusion would result from moderate or severe illness and/or oral temperature \\>100.4˚F within 3 days of injection or chronic condition that, in opinion of investigator, would render injection unsafe or would interfere with evaluations.'}, 'identificationModule': {'nctId': 'NCT00119067', 'acronym': 'AVRP', 'briefTitle': 'Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Anthrax Vaccine Adsorbed: Human Reactogenicity and Immunogenicity Trial to Address Change in Route of Administration and Dose Reduction', 'orgStudyIdInfo': {'id': 'CDC-NCID-3344'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Anthrax Vaccine Adsorbed 8-SQ', 'description': 'receive 8 injections of AVA injected SQ at the same points as the original licensure: 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.', 'interventionNames': ['Biological: Anthrax Vaccine Adsorbed']}, {'type': 'EXPERIMENTAL', 'label': 'Anthrax Vaccine Adsorbed 8-IM', 'description': 'receive 8 injections of AVA IM administered at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.', 'interventionNames': ['Biological: Anthrax Vaccine Adsorbed']}, {'type': 'EXPERIMENTAL', 'label': 'Anthrax Vaccine Adsorbed 7-IM', 'description': 'receive 7 injections of AVA IM administered at 0m, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.', 'interventionNames': ['Biological: Anthrax Vaccine Adsorbed']}, {'type': 'EXPERIMENTAL', 'label': 'Anthrax Vaccine Adsorbed 5-IM', 'description': 'receive 5 injections of AVA IM administered at 0m, 1m, 6m, and 2 boosters - 30m and 42m.', 'interventionNames': ['Biological: Anthrax Vaccine Adsorbed']}, {'type': 'EXPERIMENTAL', 'label': 'Anthrax Vaccine Adsorbed 4-IM', 'description': 'receive 4 injections of AVA IM; months 0, 2, 6 and a booster at month 42', 'interventionNames': ['Biological: Anthrax Vaccine Adsorbed']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline placebo IM or SQ', 'description': 'Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.', 'interventionNames': ['Biological: Saline injection']}], 'interventions': [{'name': 'Anthrax Vaccine Adsorbed', 'type': 'BIOLOGICAL', 'otherNames': ['AVA', 'BioThrax'], 'armGroupLabels': ['Anthrax Vaccine Adsorbed 4-IM', 'Anthrax Vaccine Adsorbed 5-IM', 'Anthrax Vaccine Adsorbed 7-IM', 'Anthrax Vaccine Adsorbed 8-IM', 'Anthrax Vaccine Adsorbed 8-SQ']}, {'name': 'Saline injection', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Saline placebo IM or SQ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-2050', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama, Birmingham (UAB)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '20910-7500', 'city': 'Silver Spring', 'state': 'Maryland', 'country': 'United States', 'facility': 'Walter Reed Army Institute for Research (WRAIR)', 'geoPoint': {'lat': 38.99067, 'lon': -77.02609}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jennifer Wright, DVM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centers for Disease Control and Prevention'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'collaborators': [{'name': 'Walter Reed Army Institute of Research (WRAIR)', 'class': 'FED'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'Emory University', 'class': 'OTHER'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}