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Ignite Creation Date: 2025-12-26 @ 10:45 PM

Ignite Modification Date: 2026-03-08 @ 11:46 PM

Study NCT ID: NCT01887912

Status: TERMINATED

Last Update Posted: 2022-03-28

First Post: 2013-06-20

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}], 'ancestors': [{'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': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Medical Director', 'phoneExt': '1#', 'organization': 'Sanofi Pasteur'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data was collected throughout the study (up to 3 years).', 'description': 'Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).', 'otherNumAtRisk': 6113, 'deathsNumAtRisk': 6113, 'otherNumAffected': 1347, 'seriousNumAtRisk': 6113, 'deathsNumAffected': 255, 'seriousNumAffected': 1662}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).', 'otherNumAtRisk': 3057, 'deathsNumAtRisk': 3057, 'otherNumAffected': 401, 'seriousNumAtRisk': 3057, 'deathsNumAffected': 127, 'seriousNumAffected': 851}], 'otherEvents': [{'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1252, 'numAffected': 855}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 157, 'numAffected': 127}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 456, 'numAffected': 325}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 195, 'numAffected': 135}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 481, 'numAffected': 345}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 205, 'numAffected': 146}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 556, 'numAffected': 368}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 201, 'numAffected': 132}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 758, 'numAffected': 531}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 327, 'numAffected': 229}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Antiphospholipid Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Haemolytic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Haemorrhagic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Microcytic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Nephrogenic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Normochromic Normocytic Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 59, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 15, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Aortic Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Aortic Valve Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Arrhythmia Supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Arteriosclerosis Coronary Artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 53, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Atrial Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Atrial Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Atrioventricular Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Atrioventricular Block Complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Bundle Branch Block Left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cardiac Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 40, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 36, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 22, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cardiac Failure Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 102, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 37, 'numAffected': 29}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cardiac Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cardiac Valve Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cardio-Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cardiogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cardiopulmonary Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cardiorenal Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cor Pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Coronary Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Coronary Artery Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Heart Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Hypertensive Heart Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Intracardiac Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Ischaemic Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Left Ventricular Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Prinzmetal Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Pulseless Electrical Activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Reperfusion Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 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'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Benign Bone Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Bladder Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Bladder Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Bladder Transitional Cell Carcinoma Recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Bladder Transitional Cell Carcinoma Stage Ii', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, 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'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Breast Cancer Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Breast Cancer Stage Ii', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Breast Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Bronchial Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': "Burkitt's Lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Carcinoid Tumour Of The Duodenum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 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'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Colon Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Colon Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Colon Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Diffuse Large B-Cell Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Endometrial Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Endometrial Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Eyelid Tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Gallbladder Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Gastric Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 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'Gastrointestinal Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Gastrointestinal Stromal Tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Glioblastoma Multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Hepatic Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Hepatocellular Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Intraductal Papillary Mucinous Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': "Kaposi's Sarcoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Leiomyosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 3, 'numAffected': 1}, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Lung Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Lung Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms 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{'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Malignant Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Malignant Respiratory Tract Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Mantle Cell Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Mediastinum Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Mesothelioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Metastases To Central Nervous System', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Metastases To Lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Metastatic Carcinoma Of The Bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Metastatic Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Neoplasm Of Thymus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Neoplasm Prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Neuroendocrine Tumour', 'stats': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Non-Small Cell Lung Cancer Recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Oesophageal Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Ovarian Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Ovarian Epithelial Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Pancreatic Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Pancreatic Carcinoma Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Pancreatic Neuroendocrine Tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Papillary Thyroid Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Parathyroid Tumour Benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Plasma Cell Myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 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'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Superficial Spreading Melanoma Stage Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Testicular Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Transitional Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 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'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Arachnoid Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Brain Stem Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Carotid Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Carotid Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Carpal Tunnel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cerebral Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cerebral Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 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'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Alveolitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 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'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Circulatory Collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Essential Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Extremity Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Femoral Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Hypertensive Emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Hypovolaemic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Intra-Abdominal Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Peripheral Arterial Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Peripheral Artery Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Peripheral Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Peripheral Artery Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Peripheral Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Peripheral Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Peripheral Vascular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Phlebitis Deep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Post Thrombotic Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Shock Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Subclavian Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Temporal Arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Thromboangiitis Obliterans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Thrombophlebitis Superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Varicophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Varicose Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Vascular Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Venous Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}, {'term': 'Venous Thrombosis Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3057, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDra 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Symptomatic Polymerase Chain Reaction (PCR)-Confirmed Primary C. Difficile Infection (CDI) Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6173', 'groupId': 'OG000'}, {'value': '3085', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 years post injection 1', 'description': 'Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \\>= 3 loose stools in \\<= 24 hours, loose stools (defined as type 6 \\[fluffy pieces with ragged edges, mushy\\] or type 7 \\[watery, no solid pieces\\] according to the Bristol Stool Chart) lasting \\>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on modified intent-to-treat (mITT) population which included all participants who received at least 1 injection and were analyzed according to the group to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Severe PCR-Confirmed Primary CDI Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 years post injection 1', 'description': 'Severe CDI cases were defined as number of participants with at least one of the following symptoms: fever \\>= 38.5 degree Celsius (°C), white blood cell count \\>= 15,000 cells/mm\\^3, ileus, pseudomembranous colitis, serum albumin \\<3 gram per deciliter, abdominal distension, abdominal tenderness, or admission to the intensive care unit within 7 days of CDI diagnosis.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on participants with protocol-defined (PCR confirmed) primary CDI cases.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Loose Stool Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}], 'classes': [{'title': '<3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '3 to 6', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '7 to 10', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '11 to 15', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '>15', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 years post injection 1', 'description': 'Loose stools were defined as type 6 (fluffy pieces with ragged edges, mushy) or type 7 (watery, no solid pieces) according to the Bristol Stool Chart. In this outcome measure, participants with number of loose stool episodes (categorized as: loose stool episodes less than 3, 3 to 6, 7 to 10, 11 to 15 and greater than 15) were reported.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on participants with protocol-defined PCR confirmed CDI cases.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Symptomatic PCR Confirmed CDI Cases: Per-Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4786', 'groupId': 'OG000'}, {'value': '2378', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 years post injection 1', 'description': 'Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \\>= 3 loose stools in \\<= 24 hours, loose stools (defined as type 6 \\[fluffy pieces with ragged edges, mushy\\] or type 7 \\[watery, no solid pieces\\] according to the Bristol Stool Chart) lasting \\>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. Analysis was performed on per-protocol efficacy analysis set (PPEAS).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPEAS: participants who had at least 1 injection, no relevant protocol deviations (not meet inclusion criteria/ met exclusion criteria, not receive any vaccine/not received in proper time window, received different vaccine than randomized, preparation and / or administration of vaccine not done per protocol, received protocol-restricted therapy).'}, {'type': 'SECONDARY', 'title': 'Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}], 'classes': [{'title': 'Toxin A ImunnoglobulinG (IgG): Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.957', 'groupId': 'OG000', 'lowerLimit': '0.897', 'upperLimit': '1.02'}, {'value': '0.999', 'groupId': 'OG001', 'lowerLimit': '0.912', 'upperLimit': '1.09'}]}]}, {'title': 'Toxin A IgG: Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.19', 'groupId': 'OG000', 'lowerLimit': '2.68', 'upperLimit': '3.80'}, {'value': '0.913', 'groupId': 'OG001', 'lowerLimit': '0.849', 'upperLimit': '0.983'}]}]}, {'title': 'Toxin A IgG: Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '14.3'}, {'value': '0.959', 'groupId': 'OG001', 'lowerLimit': '0.889', 'upperLimit': '1.03'}]}]}, {'title': 'Toxin A IgG: Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.7', 'groupId': 'OG000', 'lowerLimit': '38.1', 'upperLimit': '50.2'}, {'value': '0.933', 'groupId': 'OG001', 'lowerLimit': '0.867', 'upperLimit': '1.00'}]}]}, {'title': 'Toxin A IgG: Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '13.8'}, {'value': '0.944', 'groupId': 'OG001', 'lowerLimit': '0.865', 'upperLimit': '1.03'}]}]}, {'title': 'Toxin A IgG: Day 390', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.02', 'groupId': 'OG000', 'lowerLimit': '5.23', 'upperLimit': '6.93'}, {'value': '0.955', 'groupId': 'OG001', 'lowerLimit': '0.856', 'upperLimit': '1.06'}]}]}, {'title': 'Toxin A IgG: Day 570', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.50', 'groupId': 'OG000', 'lowerLimit': '3.86', 'upperLimit': '5.25'}, {'value': '0.908', 'groupId': 'OG001', 'lowerLimit': '0.834', 'upperLimit': '0.989'}]}]}, {'title': 'Toxin A IgG: Day 750', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.02', 'groupId': 'OG000', 'lowerLimit': '3.38', 'upperLimit': '4.78'}, {'value': '0.856', 'groupId': 'OG001', 'lowerLimit': '0.776', 'upperLimit': '0.944'}]}]}, {'title': 'Toxin A IgG: Day 930', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.83', 'groupId': 'OG000', 'lowerLimit': '3.02', 'upperLimit': '4.85'}, {'value': '0.902', 'groupId': 'OG001', 'lowerLimit': '0.796', 'upperLimit': '1.02'}]}]}, {'title': 'Toxin A IgG: Day 1110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.75', 'groupId': 'OG000', 'lowerLimit': '2.64', 'upperLimit': '5.34'}, {'value': '1.09', 'groupId': 'OG001', 'lowerLimit': '0.786', 'upperLimit': '1.50'}]}]}, {'title': 'Toxin B IgG: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.40', 'groupId': 'OG000', 'lowerLimit': '1.24', 'upperLimit': '1.57'}, {'value': '1.49', 'groupId': 'OG001', 'lowerLimit': '1.24', 'upperLimit': '1.79'}]}]}, {'title': 'Toxin B IgG: Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.36', 'groupId': 'OG000', 'lowerLimit': '3.37', 'upperLimit': '5.64'}, {'value': '1.56', 'groupId': 'OG001', 'lowerLimit': '1.29', 'upperLimit': '1.89'}]}]}, {'title': 'Toxin B IgG: Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '455', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '7.85', 'upperLimit': '12.8'}, {'value': '1.46', 'groupId': 'OG001', 'lowerLimit': '1.21', 'upperLimit': '1.75'}]}]}, {'title': 'Toxin B IgG: Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000', 'lowerLimit': '20.1', 'upperLimit': '30.6'}, {'value': '1.42', 'groupId': 'OG001', 'lowerLimit': '1.18', 'upperLimit': '1.71'}]}]}, {'title': 'Toxin B IgG: Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.62', 'groupId': 'OG000', 'lowerLimit': '5.36', 'upperLimit': '8.19'}, {'value': '1.31', 'groupId': 'OG001', 'lowerLimit': '1.07', 'upperLimit': '1.61'}]}]}, {'title': 'Toxin B IgG: Day 390', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.98', 'groupId': 'OG000', 'lowerLimit': '3.15', 'upperLimit': '5.02'}, {'value': '1.24', 'groupId': 'OG001', 'lowerLimit': '0.991', 'upperLimit': '1.56'}]}]}, {'title': 'Toxin B IgG: Day 570', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.37', 'groupId': 'OG000', 'lowerLimit': '2.63', 'upperLimit': '4.32'}, {'value': '1.15', 'groupId': 'OG001', 'lowerLimit': '0.905', 'upperLimit': '1.47'}]}]}, {'title': 'Toxin B IgG: Day 750', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.86', 'groupId': 'OG000', 'lowerLimit': '2.14', 'upperLimit': '3.84'}, {'value': '1.11', 'groupId': 'OG001', 'lowerLimit': '0.840', 'upperLimit': '1.47'}]}]}, {'title': 'Toxin B IgG: Day 930', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.42', 'groupId': 'OG000', 'lowerLimit': '1.65', 'upperLimit': '3.55'}, {'value': '1.13', 'groupId': 'OG001', 'lowerLimit': '0.812', 'upperLimit': '1.58'}]}]}, {'title': 'Toxin B IgG: Day 1110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.46', 'groupId': 'OG000', 'lowerLimit': '2.06', 'upperLimit': '5.81'}, {'value': '0.966', 'groupId': 'OG001', 'lowerLimit': '0.592', 'upperLimit': '1.58'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110', 'description': 'Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as geometric mean concentration (GMC). The 2-sided 95% Confidence Interval (CI) of GMC was based on the Student t-distribution. Analysis was performed on Per Protocol Immunogenicity Analysis Set, which included participants who had at least 1 injection, no relevant protocol deviations (not met inclusion criteria/ met exclusion criteria, not received vaccine/ not received in proper time window, received different vaccine than randomized, preparation and/ or administration of vaccine not per protocol, protocol-restricted therapy, not provided post-dose serology sample/serology sample did not produced a valid test result).', 'unitOfMeasure': 'ELISA units per milliliter (EU/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, 'number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}], 'classes': [{'title': 'Toxin A IgG: >=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '90.5', 'upperLimit': '95.5'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.3'}]}]}, {'title': 'Toxin A IgG: >=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '85.6', 'upperLimit': '91.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.7'}]}]}, {'title': 'Toxin B IgG: >=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000', 'lowerLimit': '78.3', 'upperLimit': '85.7'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '8.3'}]}]}, {'title': 'Toxin B IgG: >=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.2', 'groupId': 'OG000', 'lowerLimit': '68.8', 'upperLimit': '77.3'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 60', 'description': 'Percentage of Participants with \\>= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by ELISA. The 2-sided 95% Cl of the percentage was based on Exact method calculations.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Participants With CDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}], 'classes': [{'title': 'Toxin A IgG: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.15', 'groupId': 'OG000', 'lowerLimit': '0.821', 'upperLimit': '1.62'}, {'value': '1.04', 'groupId': 'OG001', 'lowerLimit': '0.661', 'upperLimit': '1.64'}]}]}, {'title': 'Toxin A IgG: Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '98.3'}, {'value': '1.06', 'groupId': 'OG001', 'lowerLimit': '0.632', 'upperLimit': '1.76'}]}]}, {'title': 'Toxin B IgG: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.41', 'groupId': 'OG000', 'lowerLimit': '0.762', 'upperLimit': '2.62'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.504', 'upperLimit': '2.20'}]}]}, {'title': 'Toxin B IgG: Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000', 'lowerLimit': '6.65', 'upperLimit': '56.2'}, {'value': '1.13', 'groupId': 'OG001', 'lowerLimit': '0.609', 'upperLimit': '2.11'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 and Day 60', 'description': 'Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as GMC. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \\>= 3 loose stools in \\<= 24 hours, loose stools (defined as type 6 \\[fluffy pieces with ragged edges, mushy\\] or type 7 \\[watery, no solid pieces\\] according to the Bristol Stool Chart) lasting \\>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on participants with protocol-defined (PCR confirmed) primary CDI cases. Here, 'number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '471', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}], 'classes': [{'title': 'Toxin A TNA: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.86', 'groupId': 'OG000', 'lowerLimit': '9.22', 'upperLimit': '10.5'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '9.12', 'upperLimit': '11.2'}]}]}, {'title': 'Toxin A TNA: Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000', 'lowerLimit': '22.7', 'upperLimit': '35.8'}, {'value': '9.86', 'groupId': 'OG001', 'lowerLimit': '8.96', 'upperLimit': '10.8'}]}]}, {'title': 'Toxin A TNA: Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000', 'lowerLimit': '40.9', 'upperLimit': '62.3'}, {'value': '9.97', 'groupId': 'OG001', 'lowerLimit': '9.09', 'upperLimit': '10.9'}]}]}, {'title': 'Toxin A TNA: Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000', 'lowerLimit': '226', 'upperLimit': '322'}, {'value': '9.82', 'groupId': 'OG001', 'lowerLimit': '8.95', 'upperLimit': '10.8'}]}]}, {'title': 'Toxin A TNA: Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000', 'lowerLimit': '228', 'upperLimit': '317'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '9.09', 'upperLimit': '11.7'}]}]}, {'title': 'Toxin A TNA: Day 390', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000', 'lowerLimit': '183', 'upperLimit': '259'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '8.86', 'upperLimit': '11.5'}]}]}, {'title': 'Toxin A TNA: Day 570', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000', 'lowerLimit': '153', 'upperLimit': '223'}, {'value': '9.86', 'groupId': 'OG001', 'lowerLimit': '8.76', 'upperLimit': '11.1'}]}]}, {'title': 'Toxin A TNA: Day 750', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000', 'lowerLimit': '148', 'upperLimit': '234'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '8.66', 'upperLimit': '12.0'}]}]}, {'title': 'Toxin A TNA: Day 930', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000', 'lowerLimit': '125', 'upperLimit': '240'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '8.57', 'upperLimit': '13.4'}]}]}, {'title': 'Toxin A TNA: Day 1110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000', 'lowerLimit': '137', 'upperLimit': '329'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '8.03', 'upperLimit': '12.9'}]}]}, {'title': 'Toxin B TNA: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '13.6'}, {'value': '13.2', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '15.6'}]}]}, {'title': 'Toxin B TNA: Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000', 'lowerLimit': '25.3', 'upperLimit': '42.2'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '15.7'}]}]}, {'title': 'Toxin B TNA: Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000', 'lowerLimit': '29.3', 'upperLimit': '48.8'}, {'value': '13.4', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '15.8'}]}]}, {'title': 'Toxin B TNA: Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000', 'lowerLimit': '34.0', 'upperLimit': '56.6'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': '17.2'}]}]}, {'title': 'Toxin B TNA: Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000', 'lowerLimit': '32.4', 'upperLimit': '53.1'}, {'value': '13.2', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '15.5'}]}]}, {'title': 'Toxin B TNA: Day 390', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '49.0'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '16.1'}]}]}, {'title': 'Toxin B TNA: Day 570', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '46.0'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '16.8'}]}]}, {'title': 'Toxin B TNA: Day 750', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000', 'lowerLimit': '25.1', 'upperLimit': '46.9'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '18.9'}]}]}, {'title': 'Toxin B TNA: Day 930', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000', 'lowerLimit': '21.1', 'upperLimit': '45.6'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '23.5'}]}]}, {'title': 'Toxin B TNA: Day 1110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000', 'lowerLimit': '26.1', 'upperLimit': '84.1'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '9.05', 'upperLimit': '21.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110', 'description': 'Serum antibody concentrations against toxins A and B were measured by TNA and expressed as geometric mean titer (GMT). The 2-sided 95% Cl of GMT was based on the Student t-distribution.', 'unitOfMeasure': 'Titer (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, 'number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}], 'classes': [{'title': 'Toxin A TNA: >=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.6', 'groupId': 'OG000', 'lowerLimit': '81.9', 'upperLimit': '88.8'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Toxin A TNA: >=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000', 'lowerLimit': '74.0', 'upperLimit': '82.0'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Toxin B TNA: >=2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '35.5'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '5.9'}]}]}, {'title': 'Toxin B TNA: >=4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '431', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000', 'lowerLimit': '23.2', 'upperLimit': '31.8'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 60', 'description': 'Percentage of Participants with \\>= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by TNA. The 2-sided 95% CI of the percentage was based on Exact method calculations.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' = participants with evaluable data for each specified category.'}, {'type': 'SECONDARY', 'title': 'Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Participants With CDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}], 'classes': [{'title': 'Toxin A TNA: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000', 'lowerLimit': '8.59', 'upperLimit': '17.9'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '6.27', 'upperLimit': '23.0'}]}]}, {'title': 'Toxin A TNA: Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000', 'lowerLimit': '83.4', 'upperLimit': '371'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '5.77', 'upperLimit': '19.7'}]}]}, {'title': 'Toxin B TNA: Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '9.46', 'upperLimit': '29.5'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '7.57', 'upperLimit': '16.3'}]}]}, {'title': 'Toxin B TNA: Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000', 'lowerLimit': '18.3', 'upperLimit': '153'}, {'value': '13.1', 'groupId': 'OG001', 'lowerLimit': '8.11', 'upperLimit': '21.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0 and Day 60', 'description': 'Serum antibody concentrations against toxins A and B were measured by TNA and were expressed as GMT. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \\>= 3 loose stools in \\<= 24 hours, loose stools (defined as type 6 \\[fluffy pieces with ragged edges, mushy\\] or type 7 \\[watery, no solid pieces\\] according to the Bristol Stool Chart) lasting \\>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.', 'unitOfMeasure': 'Titer (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on participants with protocol-defined (PCR confirmed) primary CDI cases. Here, 'number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'OG000'}, {'value': '608', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}], 'classes': [{'title': 'Injection site Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1199', 'groupId': 'OG000'}, {'value': '586', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000'}, {'value': '13.5', 'groupId': 'OG001'}]}]}, {'title': 'Injection site Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1196', 'groupId': 'OG000'}, {'value': '587', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection site Swelling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1197', 'groupId': 'OG000'}, {'value': '587', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1173', 'groupId': 'OG000'}, {'value': '577', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1196', 'groupId': 'OG000'}, {'value': '586', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}]}]}, {'title': 'Malaise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1196', 'groupId': 'OG000'}, {'value': '586', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1196', 'groupId': 'OG000'}, {'value': '586', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}, {'value': '21.2', 'groupId': 'OG001'}]}]}, {'title': 'Arthralgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1196', 'groupId': 'OG000'}, {'value': '586', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 to Day 6 after any vaccination', 'description': 'Solicited injection site reactions: pain, erythema, and swelling. Pain: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Erythema and swelling: Grade 1: \\>= 25 to \\<=50 mm, Grade 2: \\>51 to \\<=100 mm, Grade 3: \\>100 mm. Solicited systemic reactions: fever, headache, malaise, myalgia, and arthralgia. Fever: Grade 1: \\>= 38.0°C to \\<=38.4°C or \\>= 100.4° Fahrenheit (F) to \\<=101.1°F, Grade 2: \\>=38.5°C to \\<= 38.9°C or \\>=101.2°F to \\<=102.0°F, Grade 3: \\>=39.0°C or \\>=102.1°F. Headache, malaise, and myalgia: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Arthralgia: Grade 1: free range of motion but complains of pain or discomfort, Grade 2: decreased range of motion due to pain or discomfort, Grade 3: unwilling to move due to pain.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on all participants who received vaccine and were evaluable for reactogenicity. Here, 'number analyzed' = participants with available data for each specified category."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6201'}, {'groupId': 'FG001', 'numSubjects': '3101'}]}, {'type': 'Safety Population', 'comment': 'Participants who had received the study or control vaccine, analyzed according to vaccine received', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6113'}, {'groupId': 'FG001', 'numSubjects': '3057'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4809'}, {'groupId': 'FG001', 'numSubjects': '2370'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1392'}, {'groupId': 'FG001', 'numSubjects': '731'}]}], 'dropWithdraws': [{'type': 'Serious adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '400'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'Other Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '606'}, {'groupId': 'FG001', 'numSubjects': '349'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '58'}]}]}], 'recruitmentDetails': 'Study participants were enrolled in the study from 30 July 2013 to 17 November 2017.', 'preAssignmentDetails': 'A total of 9302 participants were enrolled and randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6201', 'groupId': 'BG000'}, {'value': '3101', 'groupId': 'BG001'}, {'value': '9302', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'C. Difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'spread': '8.86', 'groupId': 'BG000'}, {'value': '65.8', 'spread': '8.87', 'groupId': 'BG001'}, {'value': '65.8', 'spread': '8.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2629', 'groupId': 'BG000'}, {'value': '1294', 'groupId': 'BG001'}, {'value': '3923', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3572', 'groupId': 'BG000'}, {'value': '1807', 'groupId': 'BG001'}, {'value': '5379', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '330', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '501', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2780', 'groupId': 'BG000'}, {'value': '1390', 'groupId': 'BG001'}, {'value': '4170', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3091', 'groupId': 'BG000'}, {'value': '1540', 'groupId': 'BG001'}, {'value': '4631', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '795', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '1193', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2983', 'groupId': 'BG000'}, {'value': '1487', 'groupId': 'BG001'}, {'value': '4470', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2198', 'groupId': 'BG000'}, {'value': '1099', 'groupId': 'BG001'}, {'value': '3297', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-14', 'size': 1011687, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-11T09:05', 'hasProtocol': True}, {'date': '2017-09-05', 'size': 1523342, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-11T12:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was observer-blind. The vaccine preparer and administrator may have been unblinded to treatment assignment due to the steps necessary for vaccine preparation. However, the participant, the Investigator, and study staff members who collected the safety data and laboratory personnel who analyzed the blood and stool samples were all blinded to the group assignment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9302}}, 'statusModule': {'whyStopped': 'The Independent Data Monitoring Committee (IDMC) concluded that the probability that the study will meet its primary objective is low.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2013-06-20', 'resultsFirstSubmitDate': '2019-06-11', 'studyFirstSubmitQcDate': '2013-06-24', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-11', 'studyFirstPostDateStruct': {'date': '2013-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Symptomatic Polymerase Chain Reaction (PCR)-Confirmed Primary C. Difficile Infection (CDI) Cases', 'timeFrame': 'Up to 3 years post injection 1', 'description': 'Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \\>= 3 loose stools in \\<= 24 hours, loose stools (defined as type 6 \\[fluffy pieces with ragged edges, mushy\\] or type 7 \\[watery, no solid pieces\\] according to the Bristol Stool Chart) lasting \\>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Severe PCR-Confirmed Primary CDI Cases', 'timeFrame': 'Up to 3 years post injection 1', 'description': 'Severe CDI cases were defined as number of participants with at least one of the following symptoms: fever \\>= 38.5 degree Celsius (°C), white blood cell count \\>= 15,000 cells/mm\\^3, ileus, pseudomembranous colitis, serum albumin \\<3 gram per deciliter, abdominal distension, abdominal tenderness, or admission to the intensive care unit within 7 days of CDI diagnosis.'}, {'measure': 'Number of Participants With Loose Stool Episodes', 'timeFrame': 'Up to 3 years post injection 1', 'description': 'Loose stools were defined as type 6 (fluffy pieces with ragged edges, mushy) or type 7 (watery, no solid pieces) according to the Bristol Stool Chart. In this outcome measure, participants with number of loose stool episodes (categorized as: loose stool episodes less than 3, 3 to 6, 7 to 10, 11 to 15 and greater than 15) were reported.'}, {'measure': 'Number of Participants With Symptomatic PCR Confirmed CDI Cases: Per-Protocol Population', 'timeFrame': 'Up to 3 years post injection 1', 'description': 'Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \\>= 3 loose stools in \\<= 24 hours, loose stools (defined as type 6 \\[fluffy pieces with ragged edges, mushy\\] or type 7 \\[watery, no solid pieces\\] according to the Bristol Stool Chart) lasting \\>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. Analysis was performed on per-protocol efficacy analysis set (PPEAS).'}, {'measure': 'Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)', 'timeFrame': 'Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110', 'description': 'Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as geometric mean concentration (GMC). The 2-sided 95% Confidence Interval (CI) of GMC was based on the Student t-distribution. Analysis was performed on Per Protocol Immunogenicity Analysis Set, which included participants who had at least 1 injection, no relevant protocol deviations (not met inclusion criteria/ met exclusion criteria, not received vaccine/ not received in proper time window, received different vaccine than randomized, preparation and/ or administration of vaccine not per protocol, protocol-restricted therapy, not provided post-dose serology sample/serology sample did not produced a valid test result).'}, {'measure': 'Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA', 'timeFrame': 'Day 60', 'description': 'Percentage of Participants with \\>= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by ELISA. The 2-sided 95% Cl of the percentage was based on Exact method calculations.'}, {'measure': 'Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Participants With CDI', 'timeFrame': 'Day 0 and Day 60', 'description': 'Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as GMC. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \\>= 3 loose stools in \\<= 24 hours, loose stools (defined as type 6 \\[fluffy pieces with ragged edges, mushy\\] or type 7 \\[watery, no solid pieces\\] according to the Bristol Stool Chart) lasting \\>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.'}, {'measure': 'Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)', 'timeFrame': 'Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110', 'description': 'Serum antibody concentrations against toxins A and B were measured by TNA and expressed as geometric mean titer (GMT). The 2-sided 95% Cl of GMT was based on the Student t-distribution.'}, {'measure': 'Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA', 'timeFrame': 'Day 60', 'description': 'Percentage of Participants with \\>= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by TNA. The 2-sided 95% CI of the percentage was based on Exact method calculations.'}, {'measure': 'Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Participants With CDI', 'timeFrame': 'Day 0 and Day 60', 'description': 'Serum antibody concentrations against toxins A and B were measured by TNA and were expressed as GMT. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \\>= 3 loose stools in \\<= 24 hours, loose stools (defined as type 6 \\[fluffy pieces with ragged edges, mushy\\] or type 7 \\[watery, no solid pieces\\] according to the Bristol Stool Chart) lasting \\>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.'}, {'measure': 'Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions', 'timeFrame': 'Day 0 to Day 6 after any vaccination', 'description': 'Solicited injection site reactions: pain, erythema, and swelling. Pain: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Erythema and swelling: Grade 1: \\>= 25 to \\<=50 mm, Grade 2: \\>51 to \\<=100 mm, Grade 3: \\>100 mm. Solicited systemic reactions: fever, headache, malaise, myalgia, and arthralgia. Fever: Grade 1: \\>= 38.0°C to \\<=38.4°C or \\>= 100.4° Fahrenheit (F) to \\<=101.1°F, Grade 2: \\>=38.5°C to \\<= 38.9°C or \\>=101.2°F to \\<=102.0°F, Grade 3: \\>=39.0°C or \\>=102.1°F. Headache, malaise, and myalgia: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Arthralgia: Grade 1: free range of motion but complains of pain or discomfort, Grade 2: decreased range of motion due to pain or discomfort, Grade 3: unwilling to move due to pain.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clostridium difficile Toxoid Vaccine', 'Clostridium difficile infection', 'Cdiffense'], 'conditions': ['Clostridium Difficile Infection']}, 'referencesModule': {'references': [{'pmid': '32946836', 'type': 'DERIVED', 'citation': 'de Bruyn G, Gordon DL, Steiner T, Tambyah P, Cosgrove C, Martens M, Bassily E, Chan ES, Patel D, Chen J, Torre-Cisneros J, Fernando De Magalhaes Francesconi C, Gesser R, Jeanfreau R, Launay O, Laot T, Morfin-Otero R, Oviedo-Orta E, Park YS, Piazza FM, Rehm C, Rivas E, Self S, Gurunathan S. Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial. Lancet Infect Dis. 2021 Feb;21(2):252-262. doi: 10.1016/S1473-3099(20)30331-5. Epub 2020 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need.\n\nPrimary objective:\n\n* To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged \\>= 50 years who are at risk for CDI and have received at least 1 injection.\n\nSecondary Objectives:\n\nEfficacy:\n\n* To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days.\n* To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections.\n\nImmunogenicity:\n\n* To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60.\n\nSafety:\n\n* To describe the safety profile of all participants who received at least 1 injection.', 'detailedDescription': 'The study was designed as an event-driven group sequential protocol with 4 interim analyses at defined information milestones and a final analysis when a specific number of clinical endpoints are reached. Analyses of trial futility (non-efficacy) were to be performed at the first 2 interim analyses, and the study was to be stopped if either of those analyses provided robust and compelling evidence that meaningful levels of vaccine efficacy (VE) would not be demonstrated.\n\nFollowing completion of the first interim analysis (50 cases of confirmed CDI observed), the futility criterion was met and in accordance with IDMC recommendation, enrollment and further vaccination ceased in November 2017.\n\nDue to the early termination of the study, some of the planned secondary efficacy endpoints could not be analyzed as all planned data were not collected.\n\nParticipants were randomized to receive either the candidate vaccine or a placebo that was to be administered in a 3-dose schedule. At the time of group assignment, 928 participants (10% of total enrollment) were randomized to an immunogenicity subset; and 1859 participants (20% of total enrollment) were randomized to a reactogenicity subset.\n\nSafety was assessed in all participants in terms of unsolicited adverse events from Day 0 to Day 60, as well as serious adverse events (SAEs) throughout the study. Solicited adverse reactions were collected for 6 days following each injection in the reactogenicity subset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\>= 50 years on the day of inclusion\n* Informed consent form had been signed and dated.\n* Attended all scheduled visits and complied with all trial procedures.\n* Covered by health insurance (if required).\n* Must fulfill at least 1 of the following criteria\n\nRisk Stratum 1:\n\n* Had at least 2 hospital stays, each lasting at least \\>= 24 hours, in the 12 months before enrollment, and\n* Had received systemic (not topical) antibiotics in the 12 months before enrollment, or\n\nRisk Stratum 2:\n\n* Was anticipated to have an in-patient hospitalization for a planned surgical procedure within 60 days of enrollment. The impending hospital stay was planned to be \\>= 72 hours for a surgery involving 1 of the following:\n* Kidney/bladder/urinary system\n* Musculoskeletal system\n* Respiratory system\n* Circulatory system\n* Central nervous system.\n\nExclusion Criteria:\n\n* Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination).\n* Participation in the 4 weeks preceding the first trial vaccination or participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.\n* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination except for influenza (seasonal or pandemic) and pneumococcal vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.\n* Previous vaccination against C. difficile with either the trial vaccine, another vaccine, or monoclonal antibodies.\n* Diarrhea on day of enrollment.\n* Self-reported current or prior CDI episode.\n* Anticipated or current receipt of kidney dialysis treatment.\n* History of gastrointestinal surgery for gastrointestinal malignancy (Note: Colonoscopy, polypectomy, and appendectomy are not exclusion criteria).\n* History of inflammatory bowel disease, irritable bowel syndrome (must include diarrhea as a symptom), colostomy, or small or large intestine bowel surgery where resection was performed.\n* Receiving enteral feeding (e.g., nasogastric, gastrostomy, and jejunostomy tube feeding).\n* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).\n* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.\n* Self-reported thrombocytopenia, contraindicating intramuscular vaccination.\n* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.\n* Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures in the opinion of the Investigator.\n* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.\n* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature \\>= 38.0 degree Celsius \\[\\>= 100.4°Fahrenheit\\]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.\n* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.'}, 'identificationModule': {'nctId': 'NCT01887912', 'briefTitle': 'Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (Cdiffense™)', 'orgStudyIdInfo': {'id': 'H-030-014'}, 'secondaryIdInfos': [{'id': '2013-000775-32', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1127-7162', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C. difficile Vaccine Group', 'description': 'Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).', 'interventionNames': ['Biological: C. difficile Toxoid Vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).', 'interventionNames': ['Biological: Placebo: 0.9% normal saline']}], 'interventions': [{'name': 'C. difficile Toxoid Vaccine', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['C. difficile Vaccine Group']}, {'name': 'Placebo: 0.9% normal saline', 'type': 'BIOLOGICAL', 'description': '0.5 mL, Intramuscular', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35803', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site 104', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '86001', 'city': 'Flagstaff', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 35.19807, 'lon': -111.65127}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site 194', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85374', 'city': 'Surprise', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site 503', 'geoPoint': {'lat': 33.63059, 'lon': -112.33322}}, {'zip': '72205', 'city': 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{'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site 084', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70570', 'city': 'Opelousas', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.53353, 'lon': -92.08151}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site 077', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site 002', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02132', 'city': 'West Roxbury', 'state': 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