Viewing Study NCT01352793

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Ignite Creation Date: 2025-12-25 @ 1:08 AM
Ignite Modification Date: 2025-12-27 @ 2:23 AM
Study NCT ID: NCT01352793
Status: COMPLETED
Last Update Posted: 2015-03-11
First Post: 2011-05-11
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008585', 'term': 'Meningitis, Meningococcal'}], 'ancestors': [{'id': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were recorded from Vaccination 1 to 1 month after last vaccination. SAEs, newly diagnosed chronic medical conditions and medically attended adverse events were recorded from Vaccination 1 to 6 months after the last vaccination', 'description': 'SAEs and AEs were grouped by system organ class and summarized. AEs collected on the case report form at each visit (non-systematic assessment).', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: rLP2086', 'description': 'Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule', 'otherNumAtRisk': 3796, 'otherNumAffected': 1671, 'seriousNumAtRisk': 3796, 'seriousNumAffected': 59}, {'id': 'EG001', 'title': 'Group 2: HAV/Saline/HAV', 'description': 'Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month', 'otherNumAtRisk': 1908, 'otherNumAffected': 640, 'seriousNumAtRisk': 1908, 'seriousNumAffected': 48}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 722}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 149}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 237}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 142}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Vaccination site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 157}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 87}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 149}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 84}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 47}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 38}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Viral pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 30}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 23}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 24}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 249}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 102}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 41}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 34}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Autoimmune thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Hyperprolactinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Hypothalamo-pituitary disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Duodenal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Duodenal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Breast abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Carbuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Meningitis enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Meningitis enteroviral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Pertussis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Salpingitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Tick-borne viral encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Heat stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Snake bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Traumatic intracranial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Central Nervous System germinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Demyelination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Meningism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Radicular syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Abortion missed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Substance abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Attention deficit or hyperactivity disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Schizoaffective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Testicular torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Ingrowing nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3796, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1908, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3796', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086', 'description': 'Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule'}, {'id': 'OG001', 'title': 'Group 2: HAV/Saline/HAV', 'description': 'Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month'}], 'classes': [{'categories': [{'measurements': [{'value': '1.55', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '2.0'}, {'value': '2.52', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '3.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Vaccination 1 up to 6 months after Vaccination 3', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3796', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086', 'description': 'Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule'}, {'id': 'OG001', 'title': 'Group 2: HAV/Saline/HAV', 'description': 'Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month'}], 'classes': [{'categories': [{'measurements': [{'value': '7.03', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '7.9'}, {'value': '6.13', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '7.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days after Vaccination 1', 'description': 'A medically attended AE was defined as a non-serious AE that required medical attention.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 1 safety population included all participants who received the first dose of study vaccine (bivalent rLP2086 or HAV vaccine) and had safety information available from Vaccination 1 until prior to Vaccination 2.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3529', 'groupId': 'OG000'}, {'value': '1806', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086', 'description': 'Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule'}, {'id': 'OG001', 'title': 'Group 2: HAV/Saline/HAV', 'description': 'Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month'}], 'classes': [{'categories': [{'measurements': [{'value': '5.50', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '6.3'}, {'value': '6.09', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '7.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days after Vaccination 2', 'description': 'A medically attended AE was defined as a non-serious AE that required medical attention.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 2 safety population included all participants who received the second dose of study vaccine (bivalent rLP2086 or saline) and had safety information available from Vaccination 2 until prior to Vaccination 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3313', 'groupId': 'OG000'}, {'value': '1710', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086', 'description': 'Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 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month after Vaccination 3).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3796', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086', 'description': 'Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule'}, {'id': 'OG001', 'title': 'Group 2: HAV/Saline/HAV', 'description': 'Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month'}], 'classes': [{'title': '30 days after Vaccination 1 (N=3796, 1908)', 'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.4'}, {'value': '0.42', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.8'}]}]}, {'title': '30 days after Vaccination 2 (N=3529, 1806)', 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.4'}, {'value': '0.44', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.9'}]}]}, {'title': '30 days after Vaccination 3 (N=3313, 1710)', 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.6'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': '30 days after any vaccination (N=3796, 1908)', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '0.9'}, {'value': '0.94', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '1.5'}]}]}, {'title': 'Vaccination phase (N=3796, 1908)', 'categories': [{'measurements': [{'value': '1.16', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.6'}, {'value': '1.83', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '2.5'}]}]}, {'title': 'Follow-up phase (N=3400, 1733)', 'categories': [{'measurements': [{'value': '0.44', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.7'}, {'value': '0.87', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '1.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)', 'description': "An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. 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vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)', 'description': 'A medically attended AE was defined as a non-serious AE that required medical attention.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3796', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086', 'description': 'Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule'}, {'id': 'OG001', 'title': 'Group 2: HAV/Saline/HAV', 'description': 'Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month'}], 'classes': [{'title': '30 days after Vaccination 1 (N=3796, 1908)', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.4'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': '30 days after Vaccination 2 (N=3529, 1806)', 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.4'}, {'value': '0.33', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.7'}]}]}, {'title': '30 days after Vaccination 3 (N=3313, 1710)', 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.3'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': '30 days after any vaccination (N=3796, 1908)', 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.7'}, {'value': '0.52', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1.0'}]}]}, {'title': 'Vaccination phase (N=3796, 1908)', 'categories': [{'measurements': [{'value': '1.03', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '1.4'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '1.6'}]}]}, {'title': 'Follow-up phase (N=3400, 1733)', 'categories': [{'measurements': [{'value': '0.44', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.7'}, {'value': '0.52', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.0'}]}]}, {'title': 'Throughout study (N=3796, 1908)', 'categories': [{'measurements': [{'value': '1.40', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.8'}, {'value': '1.52', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)', 'description': "A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3796', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086', 'description': 'Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule'}, {'id': 'OG001', 'title': 'Group 2: HAV/Saline/HAV', 'description': 'Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month'}], 'classes': [{'title': '30 days after Vaccination 1 (N=3796, 1908)', 'categories': [{'measurements': [{'value': '31.48', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '33.0'}, {'value': '19.03', 'groupId': 'OG001', 'lowerLimit': '17.3', 'upperLimit': '20.9'}]}]}, {'title': '30 days after Vaccination 2 (N=3529, 1806)', 'categories': [{'measurements': [{'value': '20.37', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '21.7'}, {'value': '12.35', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '14.0'}]}]}, {'title': '30 days after Vaccination 3 (N=3313, 1710)', 'categories': [{'measurements': [{'value': '15.00', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '16.3'}, {'value': '10.76', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '12.3'}]}]}, {'title': '30 days after any vaccination (N=3796, 1908)', 'categories': [{'measurements': [{'value': '43.02', 'groupId': 'OG000', 'lowerLimit': '41.4', 'upperLimit': '44.6'}, {'value': '31.45', 'groupId': 'OG001', 'lowerLimit': '29.4', 'upperLimit': '33.6'}]}]}, {'title': 'Vaccination phase (N=3796, 1908)', 'categories': [{'measurements': [{'value': '51.08', 'groupId': 'OG000', 'lowerLimit': '49.5', 'upperLimit': '52.7'}, {'value': '42.51', 'groupId': 'OG001', 'lowerLimit': '40.3', 'upperLimit': '44.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)', 'description': "An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3796', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086', 'description': 'Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule'}, {'id': 'OG001', 'title': 'Group 2: HAV/Saline/HAV', 'description': 'Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month'}], 'classes': [{'title': 'Vaccination 1 (N=3796, 1908)', 'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.4'}, {'value': '0.84', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '1.4'}]}]}, {'title': 'Vaccination 2 (N=3529, 1806)', 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.8'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.3'}]}]}, {'title': 'Vaccination 3 (N=3313, 1710)', 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.7'}, {'value': '0.41', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 minutes after Vaccination 1, 2, 3', 'description': "An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.'}, {'type': 'SECONDARY', 'title': 'Number of Days Participant Missed School or Work Due to Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3796', 'groupId': 'OG000'}, {'value': '1908', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: rLP2086', 'description': 'Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule'}, {'id': 'OG001', 'title': 'Group 2: HAV/Saline/HAV', 'description': 'Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '7.01', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '110'}, {'value': '3.0', 'spread': '9.67', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '136'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Vaccination 1 up to 1 month after Vaccination 3', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: rLP2086', 'description': 'Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule'}, {'id': 'FG001', 'title': 'Group 2: HAV/Saline/HAV', 'description': 'Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3804'}, {'groupId': 'FG001', 'numSubjects': '1908'}]}, {'type': 'Vaccination 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3796'}, {'groupId': 'FG001', 'numSubjects': '1908'}]}, {'type': 'Vaccination 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3530'}, {'groupId': 'FG001', 'numSubjects': '1806'}]}, {'type': 'Vaccination 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3314'}, {'groupId': 'FG001', 'numSubjects': '1710'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3219'}, {'groupId': 'FG001', 'numSubjects': '1663'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '585'}, {'groupId': 'FG001', 'numSubjects': '245'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '289'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Medication error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomized but not vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No longer meets eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}], 'preAssignmentDetails': 'A total of 5712 participants in 12 countries were enrolled in this study. Of these, 8 participants were randomized but did not receive study vaccination.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3804', 'groupId': 'BG000'}, {'value': '1908', 'groupId': 'BG001'}, {'value': '5712', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: rLP2086', 'description': 'Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule'}, {'id': 'BG001', 'title': 'Group 2: HAV/Saline/HAV', 'description': 'Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '17.4', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '17.4', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1962', 'groupId': 'BG000'}, {'value': '994', 'groupId': 'BG001'}, {'value': '2956', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1842', 'groupId': 'BG000'}, {'value': '914', 'groupId': 'BG001'}, {'value': '2756', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all participants who were randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5715}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-25', 'studyFirstSubmitDate': '2011-05-11', 'resultsFirstSubmitDate': '2015-02-25', 'studyFirstSubmitQcDate': '2011-05-11', 'lastUpdatePostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-25', 'studyFirstPostDateStruct': {'date': '2011-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study', 'timeFrame': 'Vaccination 1 up to 6 months after Vaccination 3', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.'}, {'measure': 'Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1', 'timeFrame': 'Within 30 days after Vaccination 1', 'description': 'A medically attended AE was defined as a non-serious AE that required medical attention.'}, {'measure': 'Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2', 'timeFrame': 'Within 30 days after Vaccination 2', 'description': 'A medically attended AE was defined as a non-serious AE that required medical attention.'}, {'measure': 'Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3', 'timeFrame': 'Within 30 days after Vaccination 3', 'description': 'A medically attended AE was defined as a non-serious AE that required medical attention.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods', 'timeFrame': 'Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)', 'description': "An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period."}, {'measure': 'Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods', 'timeFrame': 'Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)', 'description': 'A medically attended AE was defined as a non-serious AE that required medical attention.'}, {'measure': 'Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods', 'timeFrame': 'Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)', 'description': "A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period."}, {'measure': 'Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods', 'timeFrame': 'Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)', 'description': "An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period."}, {'measure': 'Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination', 'timeFrame': 'Within 30 minutes after Vaccination 1, 2, 3', 'description': "An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period."}, {'measure': 'Number of Days Participant Missed School or Work Due to Adverse Events (AEs)', 'timeFrame': 'Vaccination 1 up to 1 month after Vaccination 3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['phase 3 safety study', '5700 healthy subjects', '3 vaccine doses at month 0', '2', 'and 6', 'control HAV/saline/HAV'], 'conditions': ['Meningitis, Meningococcal']}, 'referencesModule': {'references': [{'pmid': '35164991', 'type': 'DERIVED', 'citation': 'Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1971014&StudyName=A%20Global%20Phase%203%20Safety%20Study%20of%20120%20mcg%20rLP2086%20Vaccine%20in%20Adolescents%20and%20Young%20Adults%20Aged%2010%20to%2025%20Years', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.\n\nAll subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects aged 10 to 25 years.\n\nExclusion Criteria:\n\n* Previous vaccination with Hepatitis A virus vaccine\n* Previous vaccination with investigational meningococcal B vaccine\n* History of culture-proven N. meningitidis serogroup B disease\n* Any neuroinflammatory or autoimmune condition\n* Any immune defect that would prevent an effective response to the study vaccine'}, 'identificationModule': {'nctId': 'NCT01352793', 'briefTitle': 'A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years', 'orgStudyIdInfo': {'id': 'B1971014'}, 'secondaryIdInfos': [{'id': '2009-015198-11', 'type': 'EUDRACT_NUMBER'}, {'id': '6108A1-3003', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rLP2086 vaccine', 'description': 'rLP2086 vaccine', 'interventionNames': ['Biological: rLP2086 vaccine']}, {'type': 'OTHER', 'label': 'control', 'description': 'The control treatment will be HAVRIX vaccine at month 0 and 6 and a normal saline injection at month 2.', 'interventionNames': ['Biological: control']}], 'interventions': [{'name': 'rLP2086 vaccine', 'type': 'BIOLOGICAL', 'description': '120 mcg, 3 doses, at month 0, 2, and 6.', 'armGroupLabels': ['rLP2086 vaccine']}, {'name': 'control', 'type': 'BIOLOGICAL', 'description': 'HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. 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