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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 4:32 PM

Ignite Modification Date: 2026-02-22 @ 6:44 PM

Study NCT ID: NCT02302066

Status: COMPLETED

Last Update Posted: 2020-02-24

First Post: 2014-11-24

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Participants

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Colombia', 'Thailand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003715', 'term': 'Dengue'}], 'ancestors': [{'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 540); Other adverse events: From any vaccination (Day 1, Day 91, and Day 365) up to 28 days post vaccination.', 'description': 'Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Data for other (non-serious) adverse events is reported for participants from Immunogenicity Subset with available data for analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1 (TDV 2-Dose)', 'description': "Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.", 'otherNumAtRisk': 91, 'deathsNumAtRisk': 200, 'otherNumAffected': 17, 'seriousNumAtRisk': 200, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Group 2 (TDV 1-Dose)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.", 'otherNumAtRisk': 187, 'deathsNumAtRisk': 398, 'otherNumAffected': 43, 'seriousNumAtRisk': 398, 'deathsNumAffected': 1, 'seriousNumAffected': 18}, {'id': 'EG002', 'title': 'Group 3 (TDV 1-Dose + Booster)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.", 'otherNumAtRisk': 191, 'deathsNumAtRisk': 998, 'otherNumAffected': 41, 'seriousNumAtRisk': 998, 'deathsNumAffected': 1, 'seriousNumAffected': 65}, {'id': 'EG003', 'title': 'Group 4 (Placebo Control)', 'description': 'Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 198, 'otherNumAffected': 22, 'seriousNumAtRisk': 198, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Parasitic Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 187, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 191, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 93, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Immune Thrombocytopenic Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ocular Myasthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ileus Paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Food Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Amoebic Dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abscess Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ascariasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dengue Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Scarlet Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Amoebiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Appendicitis Perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Burkholderia Cepacia Complex Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Encephalomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Endometritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastroenteritis Rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Infectious Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peritonsillar Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 398, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 998, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 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'upperLimit': '237.8'}, {'value': '147.0', 'groupId': 'OG002', 'lowerLimit': '108.4', 'upperLimit': '199.2'}, {'value': '23.4', 'groupId': 'OG003', 'lowerLimit': '14.9', 'upperLimit': '36.9'}]}]}, {'title': 'DENV-1, Day 180 (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '448.8', 'groupId': 'OG000', 'lowerLimit': '293.0', 'upperLimit': '687.5'}, {'value': '463.7', 'groupId': 'OG001', 'lowerLimit': '329.5', 'upperLimit': '652.6'}, {'value': '538.9', 'groupId': 'OG002', 'lowerLimit': '391.2', 'upperLimit': '742.3'}, {'value': '55.7', 'groupId': 'OG003', 'lowerLimit': '29.2', 'upperLimit': '106.6'}]}]}, {'title': 'DENV-2, Day 180 (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1461.5', 'groupId': 'OG000', 'lowerLimit': '1071.7', 'upperLimit': '1992.9'}, {'value': '1682.9', 'groupId': 'OG001', 'lowerLimit': '1333.5', 'upperLimit': '2124.0'}, {'value': '1335.1', 'groupId': 'OG002', 'lowerLimit': '1067.7', 'upperLimit': '1669.5'}, {'value': '77.2', 'groupId': 'OG003', 'lowerLimit': '39.8', 'upperLimit': '149.6'}]}]}, {'title': 'DENV-3, Day 180 (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '150.1', 'groupId': 'OG000', 'lowerLimit': '96.9', 'upperLimit': '232.6'}, {'value': '166.3', 'groupId': 'OG001', 'lowerLimit': '117.6', 'upperLimit': '235.3'}, {'value': '173.9', 'groupId': 'OG002', 'lowerLimit': '125.8', 'upperLimit': '240.5'}, {'value': '37.4', 'groupId': 'OG003', 'lowerLimit': '21.7', 'upperLimit': '64.6'}]}]}, {'title': 'DENV-4, Day 180 (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '109.1', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '163.2'}, {'value': '110.0', 'groupId': 'OG001', 'lowerLimit': '81.0', 'upperLimit': '149.2'}, {'value': '92.3', 'groupId': 'OG002', 'lowerLimit': '68.7', 'upperLimit': '123.9'}, {'value': '22.3', 'groupId': 'OG003', 'lowerLimit': '14.1', 'upperLimit': '35.1'}]}]}, {'title': 'DENV-1, Day 365 (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '370.7', 'groupId': 'OG000', 'lowerLimit': '232.3', 'upperLimit': '591.8'}, {'value': '409.6', 'groupId': 'OG001', 'lowerLimit': '287.9', 'upperLimit': '582.5'}, {'value': '487.3', 'groupId': 'OG002', 'lowerLimit': '346.2', 'upperLimit': '686.0'}, {'value': '72.7', 'groupId': 'OG003', 'lowerLimit': '38.0', 'upperLimit': '139.1'}]}]}, {'title': 'DENV-2, Day 365 (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1070.0', 'groupId': 'OG000', 'lowerLimit': '746.7', 'upperLimit': '1533.2'}, {'value': '1529.8', 'groupId': 'OG001', 'lowerLimit': '1179.0', 'upperLimit': '1985.0'}, {'value': '1041.0', 'groupId': 'OG002', 'lowerLimit': '802.8', 'upperLimit': '1349.9'}, {'value': '133.9', 'groupId': 'OG003', 'lowerLimit': '67.7', 'upperLimit': '264.9'}]}]}, {'title': 'DENV-3, Day 365 (Month 12)', 'denoms': [{'units': 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{'value': '89.3', 'groupId': 'OG002', 'lowerLimit': '64.5', 'upperLimit': '123.6'}, {'value': '29.3', 'groupId': 'OG003', 'lowerLimit': '18.5', 'upperLimit': '46.6'}]}]}, {'title': 'DENV-1, Day 393 (Month 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '454.4', 'groupId': 'OG000', 'lowerLimit': '273.4', 'upperLimit': '755.2'}, {'value': '385.8', 'groupId': 'OG001', 'lowerLimit': '271.6', 'upperLimit': '548.2'}, {'value': '1598.8', 'groupId': 'OG002', 'lowerLimit': '1258.2', 'upperLimit': '2031.6'}, {'value': '80.6', 'groupId': 'OG003', 'lowerLimit': '41.4', 'upperLimit': '156.9'}]}]}, {'title': 'DENV-2, Day 393 (Month 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1152.4', 'groupId': 'OG000', 'lowerLimit': '796.3', 'upperLimit': '1667.6'}, {'value': '1384.1', 'groupId': 'OG001', 'lowerLimit': '1066.3', 'upperLimit': '1796.7'}, {'value': '1866.1', 'groupId': 'OG002', 'lowerLimit': '1551.4', 'upperLimit': '2244.6'}, {'value': '129.5', 'groupId': 'OG003', 'lowerLimit': '64.9', 'upperLimit': '258.6'}]}]}, {'title': 'DENV-3, Day 393 (Month 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '192.1', 'groupId': 'OG000', 'lowerLimit': '115.3', 'upperLimit': '320.3'}, {'value': '225.1', 'groupId': 'OG001', 'lowerLimit': '157.1', 'upperLimit': '322.7'}, {'value': '767.6', 'groupId': 'OG002', 'lowerLimit': '615.4', 'upperLimit': '957.4'}, {'value': '68.5', 'groupId': 'OG003', 'lowerLimit': '36.5', 'upperLimit': '128.8'}]}]}, {'title': 'DENV-4, Day 393 (Month 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '58.1', 'upperLimit': '141.2'}, {'value': '86.3', 'groupId': 'OG001', 'lowerLimit': '64.2', 'upperLimit': '116.1'}, {'value': '278.0', 'groupId': 'OG002', 'lowerLimit': '226.6', 'upperLimit': '340.9'}, {'value': '28.8', 'groupId': 'OG003', 'lowerLimit': '18.0', 'upperLimit': '46.0'}]}]}, {'title': 'DENV-1, Day 540 (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '475.9', 'groupId': 'OG000', 'lowerLimit': '286.3', 'upperLimit': '791.0'}, {'value': '461.3', 'groupId': 'OG001', 'lowerLimit': '329.1', 'upperLimit': '646.6'}, {'value': '1056.3', 'groupId': 'OG002', 'lowerLimit': '804.0', 'upperLimit': '1387.9'}, {'value': '92.2', 'groupId': 'OG003', 'lowerLimit': '49.1', 'upperLimit': '172.9'}]}]}, {'title': 'DENV-2, Day 540 (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1211.5', 'groupId': 'OG000', 'lowerLimit': '841.6', 'upperLimit': '1744.1'}, {'value': '1241.8', 'groupId': 'OG001', 'lowerLimit': '947.1', 'upperLimit': '1628.1'}, {'value': '1456.6', 'groupId': 'OG002', 'lowerLimit': '1181.7', 'upperLimit': '1795.5'}, {'value': '176.7', 'groupId': 'OG003', 'lowerLimit': '92.8', 'upperLimit': '336.7'}]}]}, {'title': 'DENV-3, Day 540 (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '285.5', 'groupId': 'OG000', 'lowerLimit': '170.7', 'upperLimit': '477.5'}, {'value': '298.0', 'groupId': 'OG001', 'lowerLimit': '205.0', 'upperLimit': '433.3'}, {'value': '548.0', 'groupId': 'OG002', 'lowerLimit': '411.2', 'upperLimit': '730.3'}, {'value': '77.6', 'groupId': 'OG003', 'lowerLimit': '44.0', 'upperLimit': '136.9'}]}]}, {'title': 'DENV-4, Day 540 (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '64.5', 'upperLimit': '149.9'}, {'value': '102.0', 'groupId': 'OG001', 'lowerLimit': '75.1', 'upperLimit': '138.6'}, {'value': '171.6', 'groupId': 'OG002', 'lowerLimit': '132.9', 'upperLimit': '221.6'}, {'value': '33.1', 'groupId': 'OG003', 'lowerLimit': '21.1', 'upperLimit': '51.9'}]}]}, {'title': 'DENV-1, Day 730 (Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '471.1', 'groupId': 'OG000', 'lowerLimit': '289.9', 'upperLimit': '765.4'}, {'value': '441.5', 'groupId': 'OG001', 'lowerLimit': '302.4', 'upperLimit': '644.3'}, {'value': '920.9', 'groupId': 'OG002', 'lowerLimit': '699.9', 'upperLimit': '1211.8'}, {'value': '114.5', 'groupId': 'OG003', 'lowerLimit': '58.8', 'upperLimit': '223.0'}]}]}, {'title': 'DENV-2, Day 730 (Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1395.5', 'groupId': 'OG000', 'lowerLimit': '962.1', 'upperLimit': '2024.3'}, {'value': '1748.2', 'groupId': 'OG001', 'lowerLimit': '1328.8', 'upperLimit': '2300.0'}, {'value': '1685.8', 'groupId': 'OG002', 'lowerLimit': '1346.1', 'upperLimit': '2111.3'}, {'value': '244.6', 'groupId': 'OG003', 'lowerLimit': '118.2', 'upperLimit': '506.3'}]}]}, {'title': 'DENV-3, Day 730 (Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '243.0', 'groupId': 'OG000', 'lowerLimit': '144.2', 'upperLimit': '409.3'}, {'value': '276.0', 'groupId': 'OG001', 'lowerLimit': '188.3', 'upperLimit': '404.7'}, {'value': '470.1', 'groupId': 'OG002', 'lowerLimit': '347.7', 'upperLimit': '635.7'}, {'value': '90.8', 'groupId': 'OG003', 'lowerLimit': '46.6', 'upperLimit': '176.8'}]}]}, {'title': 'DENV-4, Day 730 (Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '180.0', 'groupId': 'OG000', 'lowerLimit': '113.5', 'upperLimit': '285.6'}, {'value': '170.4', 'groupId': 'OG001', 'lowerLimit': '121.3', 'upperLimit': '239.4'}, {'value': '285.9', 'groupId': 'OG002', 'lowerLimit': '219.6', 'upperLimit': '372.1'}, {'value': '56.3', 'groupId': 'OG003', 'lowerLimit': '32.1', 'upperLimit': '98.9'}]}]}, {'title': 'DENV-1, Day 1095 (Month 36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '495.2', 'groupId': 'OG000', 'lowerLimit': '278.9', 'upperLimit': '879.3'}, {'value': '364.7', 'groupId': 'OG001', 'lowerLimit': '246.3', 'upperLimit': '540.1'}, {'value': '742.8', 'groupId': 'OG002', 'lowerLimit': '553.6', 'upperLimit': '996.8'}, {'value': '90.7', 'groupId': 'OG003', 'lowerLimit': '47.3', 'upperLimit': '173.7'}]}]}, {'title': 'DENV-2, Day 1095 (Month 36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1394.2', 'groupId': 'OG000', 'lowerLimit': '946.4', 'upperLimit': '2053.9'}, {'value': '1408.4', 'groupId': 'OG001', 'lowerLimit': '1057.3', 'upperLimit': '1876.0'}, {'value': '1476.2', 'groupId': 'OG002', 'lowerLimit': '1153.3', 'upperLimit': '1889.7'}, {'value': '203.5', 'groupId': 'OG003', 'lowerLimit': '100.0', 'upperLimit': '414.0'}]}]}, {'title': 'DENV-3, Day 1095 (Month 36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '262.8', 'groupId': 'OG000', 'lowerLimit': '158.2', 'upperLimit': '436.5'}, {'value': '214.9', 'groupId': 'OG001', 'lowerLimit': '144.5', 'upperLimit': '319.7'}, {'value': '364.8', 'groupId': 'OG002', 'lowerLimit': '266.4', 'upperLimit': '499.4'}, {'value': '66.4', 'groupId': 'OG003', 'lowerLimit': '35.1', 'upperLimit': '125.5'}]}]}, {'title': 'DENV-4, Day 1095 (Month 36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '201.8', 'groupId': 'OG000', 'lowerLimit': '125.2', 'upperLimit': '325.3'}, {'value': '148.1', 'groupId': 'OG001', 'lowerLimit': '104.8', 'upperLimit': '209.3'}, {'value': '236.1', 'groupId': 'OG002', 'lowerLimit': '179.4', 'upperLimit': '310.6'}, {'value': '45.7', 'groupId': 'OG003', 'lowerLimit': '27.0', 'upperLimit': '77.2'}]}]}, {'title': 'DENV-1, Day 1460 (Month 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '377.8', 'groupId': 'OG000', 'lowerLimit': '226.1', 'upperLimit': '631.5'}, {'value': '421.0', 'groupId': 'OG001', 'lowerLimit': '285.1', 'upperLimit': '621.9'}, {'value': '718.5', 'groupId': 'OG002', 'lowerLimit': '537.7', 'upperLimit': '959.9'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '49.8', 'upperLimit': '200.7'}]}]}, {'title': 'DENV-2, Day 1460 (Month 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1051.9', 'groupId': 'OG000', 'lowerLimit': '732.2', 'upperLimit': '1511.1'}, {'value': '1319.0', 'groupId': 'OG001', 'lowerLimit': '970.1', 'upperLimit': '1793.5'}, {'value': '1200.0', 'groupId': 'OG002', 'lowerLimit': '927.1', 'upperLimit': '1553.1'}, {'value': '208.1', 'groupId': 'OG003', 'lowerLimit': '99.2', 'upperLimit': '436.5'}]}]}, {'title': 'DENV-3, Day 1460 (Month 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '183.4', 'groupId': 'OG000', 'lowerLimit': '112.9', 'upperLimit': '298.0'}, {'value': '200.5', 'groupId': 'OG001', 'lowerLimit': '135.1', 'upperLimit': '297.6'}, {'value': '287.5', 'groupId': 'OG002', 'lowerLimit': '210.7', 'upperLimit': '392.4'}, {'value': '71.3', 'groupId': 'OG003', 'lowerLimit': '36.6', 'upperLimit': '138.9'}]}]}, {'title': 'DENV-4, Day 1460 (Month 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '152.0', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '239.2'}, {'value': '164.1', 'groupId': 'OG001', 'lowerLimit': '114.1', 'upperLimit': '236.0'}, {'value': '218.6', 'groupId': 'OG002', 'lowerLimit': '164.7', 'upperLimit': '290.2'}, {'value': '46.2', 'groupId': 'OG003', 'lowerLimit': '26.1', 'upperLimit': '81.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to Month 48', 'description': 'GMTs of neutralizing antibodies were measured by microneutralization test 50% \\[MNT50\\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Data reported for up to Month 48 was collected at Months 1, 3, 6, 12, 13, 18, 24, 36 and 48.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): All participants who received at least 1 dose of trial vaccine, who had a valid pre-dose and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. PPS included only participants from Immunogenicity Subset. Number analyzed are participants with data available at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (TDV 2-Dose)', 'description': "Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365."}, {'id': 'OG001', 'title': 'Group 2 (TDV 1-Dose)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365."}, {'id': 'OG002', 'title': 'Group 3 (TDV 1-Dose + Booster)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91."}, {'id': 'OG003', 'title': 'Group 4 (Placebo Control)', 'description': 'Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.'}], 'classes': [{'title': 'DENV-1, Day 28 (Month 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '91.6', 'upperLimit': '99.7'}, {'value': '97.7', 'groupId': 'OG001', 'lowerLimit': '94.1', 'upperLimit': '99.4'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '49.4', 'groupId': 'OG003', 'lowerLimit': '38.1', 'upperLimit': '60.7'}]}]}, {'title': 'DENV-2, Day 28 (Month 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '89.8', 'upperLimit': '99.2'}, {'value': '95.3', 'groupId': 'OG001', 'lowerLimit': '91.0', 'upperLimit': '98.0'}, {'value': '96.6', 'groupId': 'OG002', 'lowerLimit': '92.6', 'upperLimit': '98.7'}, {'value': '51.9', 'groupId': 'OG003', 'lowerLimit': '40.5', 'upperLimit': '63.1'}]}]}, {'title': 'DENV-3, Day 28 (Month 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '79.0', 'upperLimit': '94.1'}, {'value': '90.1', 'groupId': 'OG001', 'lowerLimit': '84.6', 'upperLimit': '94.1'}, {'value': '90.8', 'groupId': 'OG002', 'lowerLimit': '85.5', 'upperLimit': '94.7'}, {'value': '50.6', 'groupId': 'OG003', 'lowerLimit': '39.3', 'upperLimit': '61.9'}]}]}, {'title': 'DENV-4, Day 28 (Month 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '94.0', 'groupId': 'OG000', 'lowerLimit': '86.5', 'upperLimit': '98.0'}, {'value': '93.6', 'groupId': 'OG001', 'lowerLimit': '88.8', 'upperLimit': '96.7'}, {'value': '95.4', 'groupId': 'OG002', 'lowerLimit': '91.1', 'upperLimit': '98.0'}, {'value': '49.4', 'groupId': 'OG003', 'lowerLimit': '38.1', 'upperLimit': '60.7'}]}]}, {'title': 'DENV-1, Day 91 (Month 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000', 'lowerLimit': '88.1', 'upperLimit': '98.7'}, {'value': '97.7', 'groupId': 'OG001', 'lowerLimit': '94.1', 'upperLimit': '99.4'}, {'value': '99.4', 'groupId': 'OG002', 'lowerLimit': '96.8', 'upperLimit': '100.0'}, {'value': '51.9', 'groupId': 'OG003', 'lowerLimit': '40.5', 'upperLimit': '63.1'}]}]}, {'title': 'DENV-2, Day 91 (Month 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '100.0'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '95.8', 'upperLimit': '99.9'}, {'value': '99.4', 'groupId': 'OG002', 'lowerLimit': '96.8', 'upperLimit': '100.0'}, {'value': '53.1', 'groupId': 'OG003', 'lowerLimit': '41.7', 'upperLimit': '64.3'}]}]}, {'title': 'DENV-3, Day 91 (Month 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '89.2', 'groupId': 'OG000', 'lowerLimit': '80.4', 'upperLimit': '94.9'}, {'value': '95.3', 'groupId': 'OG001', 'lowerLimit': '91.0', 'upperLimit': '98.0'}, {'value': '91.4', 'groupId': 'OG002', 'lowerLimit': '86.2', 'upperLimit': '95.1'}, {'value': '48.1', 'groupId': 'OG003', 'lowerLimit': '36.9', 'upperLimit': '59.5'}]}]}, {'title': 'DENV-4, Day 91 (Month 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '79.0', 'upperLimit': '94.1'}, {'value': '90.6', 'groupId': 'OG001', 'lowerLimit': '85.3', 'upperLimit': '94.6'}, {'value': '90.8', 'groupId': 'OG002', 'lowerLimit': '85.5', 'upperLimit': '94.7'}, {'value': '45.7', 'groupId': 'OG003', 'lowerLimit': '34.6', 'upperLimit': '57.1'}]}]}, {'title': 'DENV-1, Day 180 (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '100.0'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '99.0'}, {'value': '99.4', 'groupId': 'OG002', 'lowerLimit': '96.8', 'upperLimit': '100.0'}, {'value': '49.4', 'groupId': 'OG003', 'lowerLimit': '38.1', 'upperLimit': '60.7'}]}]}, {'title': 'DENV-2, Day 180 (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.8', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG002', 'lowerLimit': '96.8', 'upperLimit': '100.0'}, {'value': '49.4', 'groupId': 'OG003', 'lowerLimit': '38.1', 'upperLimit': '60.7'}]}]}, {'title': 'DENV-3, Day 180 (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '100.0'}, {'value': '92.9', 'groupId': 'OG001', 'lowerLimit': '88.0', 'upperLimit': '96.3'}, {'value': '93.1', 'groupId': 'OG002', 'lowerLimit': '88.3', 'upperLimit': '96.4'}, {'value': '48.1', 'groupId': 'OG003', 'lowerLimit': '36.9', 'upperLimit': '59.5'}]}]}, {'title': 'DENV-4, Day 180 (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000', 'lowerLimit': '84.9', 'upperLimit': '97.3'}, {'value': '90.6', 'groupId': 'OG001', 'lowerLimit': '85.2', 'upperLimit': '94.5'}, {'value': '85.1', 'groupId': 'OG002', 'lowerLimit': '78.9', 'upperLimit': '90.0'}, {'value': '44.4', 'groupId': 'OG003', 'lowerLimit': '33.4', 'upperLimit': '55.9'}]}]}, {'title': 'DENV-1, Day 365 (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '100.0'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '93.8', 'upperLimit': '99.3'}, {'value': '97.6', 'groupId': 'OG002', 'lowerLimit': '93.9', 'upperLimit': '99.3'}, {'value': '57.9', 'groupId': 'OG003', 'lowerLimit': '46.0', 'upperLimit': '69.1'}]}]}, {'title': 'DENV-2, Day 365 (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.8', 'upperLimit': '100.0'}, {'value': '60.5', 'groupId': 'OG003', 'lowerLimit': '48.6', 'upperLimit': '71.6'}]}]}, {'title': 'DENV-3, Day 365 (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '87.5', 'upperLimit': '98.6'}, {'value': '94.4', 'groupId': 'OG001', 'lowerLimit': '89.7', 'upperLimit': '97.4'}, {'value': '90.2', 'groupId': 'OG002', 'lowerLimit': '84.6', 'upperLimit': '94.3'}, {'value': '57.9', 'groupId': 'OG003', 'lowerLimit': '46.0', 'upperLimit': '69.1'}]}]}, {'title': 'DENV-4, Day 365 (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000', 'lowerLimit': '84.2', 'upperLimit': '97.2'}, {'value': '85.1', 'groupId': 'OG001', 'lowerLimit': '78.6', 'upperLimit': '90.2'}, {'value': '82.9', 'groupId': 'OG002', 'lowerLimit': '76.3', 'upperLimit': '88.3'}, {'value': '55.3', 'groupId': 'OG003', 'lowerLimit': '43.4', 'upperLimit': '66.7'}]}]}, {'title': 'DENV-1, Day 393 (Month 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '91.3', 'upperLimit': '99.7'}, {'value': '95.7', 'groupId': 'OG001', 'lowerLimit': '91.4', 'upperLimit': '98.3'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.8', 'upperLimit': '100.0'}, {'value': '60.0', 'groupId': 'OG003', 'lowerLimit': '48.0', 'upperLimit': '71.1'}]}]}, {'title': 'DENV-2, Day 393 (Month 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '93.2', 'upperLimit': '100.0'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.8', 'upperLimit': '100.0'}, {'value': '61.3', 'groupId': 'OG003', 'lowerLimit': '49.4', 'upperLimit': '72.4'}]}]}, {'title': 'DENV-3, Day 393 (Month 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '87.7', 'upperLimit': '98.6'}, {'value': '95.1', 'groupId': 'OG001', 'lowerLimit': '90.6', 'upperLimit': '97.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.8', 'upperLimit': '100.0'}, {'value': '57.3', 'groupId': 'OG003', 'lowerLimit': '45.4', 'upperLimit': '68.7'}]}]}, {'title': 'DENV-4, Day 393 (Month 13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '81.2', 'upperLimit': '95.6'}, {'value': '86.5', 'groupId': 'OG001', 'lowerLimit': '80.3', 'upperLimit': '91.3'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.8', 'upperLimit': '100.0'}, {'value': '53.3', 'groupId': 'OG003', 'lowerLimit': '41.4', 'upperLimit': '64.9'}]}]}, {'title': 'DENV-1, Day 540 (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000', 'lowerLimit': '87.8', 'upperLimit': '98.6'}, {'value': '97.0', 'groupId': 'OG001', 'lowerLimit': '93.2', 'upperLimit': '99.0'}, {'value': '98.8', 'groupId': 'OG002', 'lowerLimit': '95.9', 'upperLimit': '99.9'}, {'value': '62.5', 'groupId': 'OG003', 'lowerLimit': '51.0', 'upperLimit': '73.1'}]}]}, {'title': 'DENV-2, Day 540 (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '100.0'}, {'value': '97.6', 'groupId': 'OG001', 'lowerLimit': '94.0', 'upperLimit': '99.3'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '68.8', 'groupId': 'OG003', 'lowerLimit': '57.4', 'upperLimit': '78.7'}]}]}, {'title': 'DENV-3, Day 540 (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000', 'lowerLimit': '87.8', 'upperLimit': '98.6'}, {'value': '92.3', 'groupId': 'OG001', 'lowerLimit': '87.1', 'upperLimit': '95.8'}, {'value': '98.3', 'groupId': 'OG002', 'lowerLimit': '95.0', 'upperLimit': '99.6'}, {'value': '63.8', 'groupId': 'OG003', 'lowerLimit': '52.2', 'upperLimit': '74.2'}]}]}, {'title': 'DENV-4, Day 540 (Month 18)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000', 'lowerLimit': '78.5', 'upperLimit': '93.9'}, {'value': '86.9', 'groupId': 'OG001', 'lowerLimit': '80.8', 'upperLimit': '91.6'}, {'value': '97.1', 'groupId': 'OG002', 'lowerLimit': '93.3', 'upperLimit': '99.0'}, {'value': '57.5', 'groupId': 'OG003', 'lowerLimit': '45.9', 'upperLimit': '68.5'}]}]}, {'title': 'DENV-1, Day 730 (Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '100.0'}, {'value': '95.9', 'groupId': 'OG001', 'lowerLimit': '91.2', 'upperLimit': '98.5'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.5', 'upperLimit': '100.0'}, {'value': '68.6', 'groupId': 'OG003', 'lowerLimit': '56.4', 'upperLimit': '79.1'}]}]}, {'title': 'DENV-2, Day 730 (Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '100.0'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.5', 'upperLimit': '100.0'}, {'value': '71.4', 'groupId': 'OG003', 'lowerLimit': '59.4', 'upperLimit': '81.6'}]}]}, {'title': 'DENV-3, Day 730 (Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000', 'lowerLimit': '86.2', 'upperLimit': '98.4'}, {'value': '93.1', 'groupId': 'OG001', 'lowerLimit': '87.7', 'upperLimit': '96.6'}, {'value': '98.6', 'groupId': 'OG002', 'lowerLimit': '95.2', 'upperLimit': '99.8'}, {'value': '65.7', 'groupId': 'OG003', 'lowerLimit': '53.4', 'upperLimit': '76.7'}]}]}, {'title': 'DENV-4, Day 730 (Month 24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000', 'lowerLimit': '86.2', 'upperLimit': '98.4'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '86.0', 'upperLimit': '95.7'}, {'value': '98.6', 'groupId': 'OG002', 'lowerLimit': '95.2', 'upperLimit': '99.8'}, {'value': '61.4', 'groupId': 'OG003', 'lowerLimit': '49.0', 'upperLimit': '72.8'}]}]}, {'title': 'DENV-1, Day 1095 (Month 36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.6', 'upperLimit': '100.0'}, {'value': '92.7', 'groupId': 'OG001', 'lowerLimit': '87.0', 'upperLimit': '96.4'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.4', 'upperLimit': '100.0'}, {'value': '68.2', 'groupId': 'OG003', 'lowerLimit': '55.6', 'upperLimit': '79.1'}]}]}, {'title': 'DENV-2, Day 1095 (Month 36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.6', 'upperLimit': '100.0'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.4', 'upperLimit': '100.0'}, {'value': '71.2', 'groupId': 'OG003', 'lowerLimit': '58.7', 'upperLimit': '81.7'}]}]}, {'title': 'DENV-3, Day 1095 (Month 36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '99.6'}, {'value': '88.3', 'groupId': 'OG001', 'lowerLimit': '81.7', 'upperLimit': '93.2'}, {'value': '98.6', 'groupId': 'OG002', 'lowerLimit': '94.9', 'upperLimit': '99.8'}, {'value': '63.6', 'groupId': 'OG003', 'lowerLimit': '50.9', 'upperLimit': '75.1'}]}]}, {'title': 'DENV-4, Day 1095 (Month 36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '87.3', 'upperLimit': '99.1'}, {'value': '88.3', 'groupId': 'OG001', 'lowerLimit': '81.7', 'upperLimit': '93.2'}, {'value': '98.6', 'groupId': 'OG002', 'lowerLimit': '94.9', 'upperLimit': '99.8'}, {'value': '63.6', 'groupId': 'OG003', 'lowerLimit': '50.9', 'upperLimit': '75.1'}]}]}, {'title': 'DENV-1, Day 1460 (Month 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000', 'lowerLimit': '89.3', 'upperLimit': '99.6'}, {'value': '94.7', 'groupId': 'OG001', 'lowerLimit': '89.5', 'upperLimit': '97.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.3', 'upperLimit': '100.0'}, {'value': '68.3', 'groupId': 'OG003', 'lowerLimit': '55.3', 'upperLimit': '79.4'}]}]}, {'title': 'DENV-2, Day 1460 (Month 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.5', 'upperLimit': '100.0'}, {'value': '98.5', 'groupId': 'OG001', 'lowerLimit': '94.7', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '97.3', 'upperLimit': '100.0'}, {'value': '68.3', 'groupId': 'OG003', 'lowerLimit': '55.3', 'upperLimit': '79.4'}]}]}, {'title': 'DENV-3, Day 1460 (Month 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.4', 'groupId': 'OG000', 'lowerLimit': '87.1', 'upperLimit': '99.0'}, {'value': '90.2', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '94.7'}, {'value': '97.8', 'groupId': 'OG002', 'lowerLimit': '93.7', 'upperLimit': '99.5'}, {'value': '63.5', 'groupId': 'OG003', 'lowerLimit': '50.4', 'upperLimit': '75.3'}]}]}, {'title': 'DENV-4, Day 1460 (Month 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.8', 'groupId': 'OG000', 'lowerLimit': '81.0', 'upperLimit': '96.5'}, {'value': '91.0', 'groupId': 'OG001', 'lowerLimit': '84.8', 'upperLimit': '95.3'}, {'value': '99.3', 'groupId': 'OG002', 'lowerLimit': '96.0', 'upperLimit': '100.0'}, {'value': '60.3', 'groupId': 'OG003', 'lowerLimit': '47.2', 'upperLimit': '72.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 1, 3, 6, 12, 13, 18, 24, 36, and 48', 'description': 'Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10 (for each serotype). The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS included all participants who received at least 1 dose of trial vaccine, who had a valid pre-dose and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. PPS included only participants from Immunogenicity Subset. Number analyzed are participants with data available at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (TDV 2-Dose) Infant/Toddler', 'description': "Participants aged \\<6 years received Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365."}, {'id': 'OG001', 'title': 'Group 2 (TDV 1-Dose) Infant/Toddler', 'description': "Participants aged \\<6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365."}, {'id': 'OG002', 'title': 'Group 3 (TDV 2-Dose) Infant/Toddler', 'description': "Participants aged \\<6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91."}, {'id': 'OG003', 'title': 'Group 4 (Placebo Control) Infant/Toddler', 'description': 'Participants aged \\<6 years received placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.'}], 'classes': [{'title': 'After Vaccination 1, Pain: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}, {'value': '12.7', 'groupId': 'OG002'}, {'value': '7.1', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Pain: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '10.9', 'groupId': 'OG002'}, {'value': '3.6', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Pain: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}, {'value': '3.6', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Erythema: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Erythema (1-2 cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Swelling: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Swelling (1-2 cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Pain: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '13.0', 'groupId': 'OG002'}, {'value': '6.9', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Pain: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '9.3', 'groupId': 'OG002'}, {'value': '6.9', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Pain: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Pain: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '8.9', 'groupId': 'OG001'}, {'value': '15.0', 'groupId': 'OG002'}, {'value': '3.4', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Pain: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '11.7', 'groupId': 'OG002'}, {'value': '3.4', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Pain: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Pain: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Swelling: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Swelling (1-2 cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after each vaccination', 'description': 'Solicited local injection included pain, erythema at injection site, and swelling at injection site. They were collected using a diary and graded as \\[Grade 0 (no pain), 1 (mild: minor reaction to touch), 2 (moderate: cries/protests on touch) and 3 (severe: cries when limb is moved/spontaneously painful)\\]. Erythema and Swelling at injection site were graded as Grade 0 (\\<10 mm), 1 (mild: ≥10 - ≤ 20 mm), 2 (moderate: \\> 20 - ≤ 40 mm) and 3 (severe: \\> 40 mm).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (TDV 2-Dose) Adult/Children', 'description': "Participants aged ≥6 years received Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365."}, {'id': 'OG001', 'title': 'Group 2 (TDV 1-Dose) Adult/Children', 'description': "Participants aged ≥6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365."}, {'id': 'OG002', 'title': 'Group 3 (TDV 1-Dose + Booster) Adult/Children', 'description': "Participants aged ≥6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91."}, {'id': 'OG003', 'title': 'Group 4 (Placebo Control) Adult/Children', 'description': 'Participant aged ≥6 years received placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.'}], 'classes': [{'title': 'After Vaccination 1, Pain: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '31.7', 'groupId': 'OG001'}, {'value': '26.8', 'groupId': 'OG002'}, {'value': '8.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Pain: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}, {'value': '22.0', 'groupId': 'OG002'}, {'value': '7.0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Pain: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}, {'value': '4.1', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Pain: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Erythema: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Erythema (2.5-5 cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Swelling: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Swelling: (2.5-5 cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Pain: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000'}, {'value': '18.1', 'groupId': 'OG001'}, {'value': '10.9', 'groupId': 'OG002'}, {'value': '14.5', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Pain: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}, {'value': '6.7', 'groupId': 'OG002'}, {'value': '10.9', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Pain: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Pain: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Pain: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '19.2', 'groupId': 'OG002'}, {'value': '16.4', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Pain: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '18.3', 'groupId': 'OG001'}, {'value': '15.8', 'groupId': 'OG002'}, {'value': '12.7', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Pain: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}, {'value': '3.6', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Pain: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Erythema: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Erythema (2.5-5 cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after each vaccination', 'description': 'Solicited local injection site reactions were collected by participant diary and graded as \\[Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)\\]. Erythema and Swelling at injection site were graded as Grade 0 (\\<25 mm), 1 (mild: ≥25 - ≤ 50 mm), 2 (moderate: \\> 50 - ≤ 100 mm).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (TDV 2-Dose) Infant/Toddler', 'description': "Participants aged \\<6 years received Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365."}, {'id': 'OG001', 'title': 'Group 2 (TDV 1-Dose) Infant/Toddler', 'description': "Participants aged \\<6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365."}, {'id': 'OG002', 'title': 'Group 3 (TDV 1-Dose + Booster) Infant/Toddler', 'description': "Participants aged \\<6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91."}, {'id': 'OG003', 'title': 'Group 4 (Placebo Control) Infant/Toddler', 'description': 'Participants aged \\<6 years received placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.'}], 'classes': [{'title': 'After Vaccination 1, Irritability: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '9.1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Irritability: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Irritability: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Irritability: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1,Drowsiness: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}, {'value': '7.1', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Drowsiness: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}, {'value': '5.5', 'groupId': 'OG002'}, {'value': '7.1', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Drowsiness: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1,Loss of Appetite:Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}, {'value': '10.9', 'groupId': 'OG002'}, {'value': '7.1', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1,Loss of Appetite: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}, {'value': '5.5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Loss of Appetite: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '3.6', 'groupId': 'OG002'}, {'value': '7.1', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Loss of Appetite: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Fever: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}, {'value': '3.7', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Fever (38.0 - < 38.5 °C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Fever (38.5 - < 39.0 °C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}, {'value': '3.7', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Irritability:Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}, {'value': '10.7', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Irritability: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}, {'value': '10.7', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Drowsiness: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Drowsiness:Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Loss of Appetite: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}, {'value': '5.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Loss of Appetite: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}, {'value': '5.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Loss of Appetite: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Loss of Appetite: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Fever, Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}, {'value': '11.5', 'groupId': 'OG002'}, {'value': '3.6', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Fever (38.0 - < 38.5 °C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Fever (38.5 - < 39.0 °C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}, {'value': '3.6', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Fever (39.0 - < 39.5 °C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Fever (39.5 - < 40.0 °C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3,Irritability: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '10.3', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Irritability: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6.9', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Irritability: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '3.4', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3,Drowsiness: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}, {'value': '3.4', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1,Drowsiness: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1,Drowsiness: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3,Drowsiness: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3.4', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3,Loss of Appetite: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}, {'value': '10.3', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Loss of Appetite: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}, {'value': '6.9', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Loss of Appetite: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3.4', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Fever: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}, {'value': '6.9', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Fever (38.0 - < 38.5 °C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '3.4', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Fever (38.5 - < 39.0 °C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Fever (39.0 - < 39.5 °C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days after each vaccination', 'description': 'Solicited systemic AEs were collected within 14 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (TDV 2-Dose) Adult/Children', 'description': "Participants aged ≥6 years received Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365."}, {'id': 'OG001', 'title': 'Group 2 (TDV 1-Dose) Adult/Children', 'description': "Participants aged ≥6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365."}, {'id': 'OG002', 'title': 'Group 3 (TDV 1-Dose + Booster) Adult/Children', 'description': "Participants aged ≥6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91."}, {'id': 'OG003', 'title': 'Group 4 (Placebo Control) Adult/Children', 'description': 'Participants aged ≥6 years received placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.'}], 'classes': [{'title': 'After Vaccination 1, Headache: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '23.8', 'groupId': 'OG001'}, {'value': '16.3', 'groupId': 'OG002'}, {'value': '21.1', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Headache: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '20.6', 'groupId': 'OG001'}, {'value': '13.0', 'groupId': 'OG002'}, {'value': '14.0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Headache: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '5.3', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Headache: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Asthenia: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}, {'value': '7.0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Asthenia: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}, {'value': '3.5', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Asthenia: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '3.5', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Asthenia: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Malaise: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '8.9', 'groupId': 'OG002'}, {'value': '10.5', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Malaise: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '13.5', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}, {'value': '8.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Malaise: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Malaise: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Myalgia: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '20.6', 'groupId': 'OG001'}, {'value': '11.4', 'groupId': 'OG002'}, {'value': '7.0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Myalgia: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '18.3', 'groupId': 'OG001'}, {'value': '10.6', 'groupId': 'OG002'}, {'value': '7.0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Myalgia: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Myalgia: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Fever: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '4.5', 'groupId': 'OG002'}, {'value': '5.9', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Fever: 38.0 - < 38.5 °C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Fever: 38.5 - < 39.0 °C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}, {'value': '3.9', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Fever: 39.0 - < 39.5 °C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 1, Fever: 39.5 - < 40.0 °C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Headache: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}, {'value': '6.8', 'groupId': 'OG002'}, {'value': '16.4', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Headache: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}, {'value': '12.7', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Headache: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '2.5', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Headache: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Asthenia: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}, {'value': '3.6', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Asthenia: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}, {'value': '2.5', 'groupId': 'OG002'}, {'value': '3.6', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Asthenia: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Asthenia: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Malaise: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '8.7', 'groupId': 'OG001'}, {'value': '6.8', 'groupId': 'OG002'}, {'value': '9.1', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Malaise: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}, {'value': '7.3', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Malaise: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Malaise: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Myalgia: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}, {'value': '5.5', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Myalgia: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}, {'value': '2.5', 'groupId': 'OG002'}, {'value': '5.5', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Myalgia: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2.5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Myalgia: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Fever: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}, {'value': '4.1', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Fever: 38.0 - < 38.5 °C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Fever: 38.5 - < 39.0 °C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}, {'value': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2, Fever: 39.5 - < 40.0 °C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}, {'value': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Headache: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}, {'value': '7.5', 'groupId': 'OG002'}, {'value': '7.3', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Headache: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}, {'value': '5.5', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Headache: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Headache: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Asthenia: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}, {'value': '2.5', 'groupId': 'OG002'}, {'value': '7.3', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Asthenia: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}, {'value': '2.5', 'groupId': 'OG002'}, {'value': '7.3', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Asthenia: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Asthenia: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Malaise: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '3.6', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Malaise: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Malaise: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '1.8', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Malaise: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Myalgia: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '5.5', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Myalgia: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}, {'value': '5.5', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Myalgia: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Myalgia: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Fever: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Fever: 38.0 - < 38.5 °C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}, {'value': '2.0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Fever: 38.5 - < 39.0 °C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3, Fever: 39.0 - < 39.5 °C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 14 days after each vaccination', 'description': 'Solicited systemic AEs were collected by participants within 14 days after vaccination and included headache, asthenia, malaise, myalgia and fever. Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (TDV 2-Dose)', 'description': "Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365."}, {'id': 'OG001', 'title': 'Group 2 (TDV 1-Dose)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365."}, {'id': 'OG002', 'title': 'Group 3 (TDV 1-Dose + Booster)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91."}, {'id': 'OG003', 'title': 'Group 4 (Placebo Control)', 'description': 'Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.'}], 'classes': [{'title': 'After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '20.3', 'groupId': 'OG001'}, {'value': '19.4', 'groupId': 'OG002'}, {'value': '21.5', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}, {'value': '11.0', 'groupId': 'OG002'}, {'value': '16.1', 'groupId': 'OG003'}]}]}, {'title': 'After Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '12.8', 'groupId': 'OG001'}, {'value': '10.1', 'groupId': 'OG002'}, {'value': '9.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days after each vaccination', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Safety Set included only participants from Immunogenicity Subset with data available for analyses. Number analyzed is number of participants with data available after each vaccination.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}, {'value': '998', 'groupId': 'OG002'}, {'value': '198', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (TDV 2-Dose)', 'description': "Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365."}, {'id': 'OG001', 'title': 'Group 2 (TDV 1-Dose)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365."}, {'id': 'OG002', 'title': 'Group 3 (TDV 1-Dose + Booster)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91."}, {'id': 'OG003', 'title': 'Group 4 (Placebo Control)', 'description': 'Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}, {'value': '6.5', 'groupId': 'OG002'}, {'value': '5.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first vaccination through end of study (Day 1460)', 'description': 'An SAE was defined as any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above-mentioned criteria.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who received at least 1 dose of trial vaccine.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Febrile Episodes of Virologically Confirmed Dengue With Onset 30 Days Post-first Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}, {'value': '998', 'groupId': 'OG002'}, {'value': '198', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (TDV 2-Dose)', 'description': "Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365."}, {'id': 'OG001', 'title': 'Group 2 (TDV 1-Dose)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365."}, {'id': 'OG002', 'title': 'Group 3 (TDV 1-Dose + Booster)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91."}, {'id': 'OG003', 'title': 'Group 4 (Placebo Control)', 'description': 'Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}, {'value': '2.2', 'groupId': 'OG002'}, {'value': '6.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 30 days post-first vaccination through end of study (Day 1460)', 'description': 'Participants with febrile illness (defined as temperature ≥ 38°C on 2 consecutive days) were evaluated for dengue. A dengue infection was considered virologically confirmed by either positive polymerase chain reaction (PCR) or NS1 enzyme-linked immunosorbent assay (ELISA). Virologically confirmed dengue with onset 30 days after first vaccination within each group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who received at least 1 dose of trial vaccine.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 (TDV 2-Dose)', 'description': "Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365."}, {'id': 'FG001', 'title': 'Group 2 (TDV 1-Dose)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365."}, {'id': 'FG002', 'title': 'Group 3 (TDV 1-Dose + Booster)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91."}, {'id': 'FG003', 'title': 'Group 4 (Placebo Control)', 'description': 'Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '398'}, {'groupId': 'FG002', 'numSubjects': '1002'}, {'groupId': 'FG003', 'numSubjects': '199'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '398'}, {'groupId': 'FG002', 'numSubjects': '998'}, {'groupId': 'FG003', 'numSubjects': '198'}]}, {'type': 'Immunogenicity Subset', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '187'}, {'groupId': 'FG002', 'numSubjects': '192'}, {'groupId': 'FG003', 'numSubjects': '94'}]}, {'type': 'Per-Protocol Set (PPS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '171'}, {'groupId': 'FG002', 'numSubjects': '174'}, {'groupId': 'FG003', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '323'}, {'groupId': 'FG002', 'numSubjects': '830'}, {'groupId': 'FG003', 'numSubjects': '158'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '172'}, {'groupId': 'FG003', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '124'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 3 investigative sites in Dominican Republic, Panama and Philippines from 05 Dec 2014 to 18 Feb 2019.', 'preAssignmentDetails': 'Healthy volunteers were enrolled in a 1:2:5:1 ratio into 4 study groups: Group 1 received two doses of Tetravalent Dengue Vaccine (TDV), Group 2 received one dose of TDV, Group 3 received one dose of TDV along with booster vaccination and Group 4 received placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '998', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}, {'value': '1794', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 (TDV 2-Dose)', 'description': "Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365."}, {'id': 'BG001', 'title': 'Group 2 (TDV 1-Dose)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365."}, {'id': 'BG002', 'title': 'Group 3 (TDV 1-Dose + Booster)', 'description': "Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91."}, {'id': 'BG003', 'title': 'Group 4 (Placebo Control)', 'description': 'Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '4.01', 'groupId': 'BG000'}, {'value': '7.3', 'spread': '4.14', 'groupId': 'BG001'}, {'value': '7.3', 'spread': '4.06', 'groupId': 'BG002'}, {'value': '7.0', 'spread': '3.96', 'groupId': 'BG003'}, {'value': '7.3', 'spread': '4.06', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '486', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}, {'value': '888', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '512', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '906', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '317', 'groupId': 'BG001'}, {'value': '825', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}, {'value': '1465', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '329', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '505', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}, {'value': '912', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '331', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '540', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '122.1', 'spread': '22.59', 'groupId': 'BG000'}, {'value': '120.9', 'spread': '23.15', 'groupId': 'BG001'}, {'value': '121.4', 'spread': '22.60', 'groupId': 'BG002'}, {'value': '119.3', 'spread': '21.88', 'groupId': 'BG003'}, {'value': '121.2', 'spread': '22.64', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '27.86', 'spread': '15.069', 'groupId': 'BG000'}, {'value': '27.25', 'spread': '14.368', 'groupId': 'BG001'}, {'value': '27.12', 'spread': '13.612', 'groupId': 'BG002'}, {'value': '25.66', 'spread': '13.371', 'groupId': 'BG003'}, {'value': '27.07', 'spread': '13.924', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '17.42', 'spread': '3.558', 'groupId': 'BG000'}, {'value': '17.43', 'spread': '3.306', 'groupId': 'BG001'}, {'value': '17.29', 'spread': '3.123', 'groupId': 'BG002'}, {'value': '16.93', 'spread': '2.975', 'groupId': 'BG003'}, {'value': '17.30', 'spread': '3.200', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index=weight/\\[height\\^2\\]', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety Analysis Set included all participants who received at least 1 dose of trial vaccine.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-31', 'size': 2507073, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-10T10:33', 'hasProtocol': False}, {'date': '2016-07-21', 'size': 25114633, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-10T11:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'dispFirstSubmitDate': '2019-08-13', 'completionDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2014-11-24', 'dispFirstSubmitQcDate': '2019-08-13', 'resultsFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2014-11-24', 'dispFirstPostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-10', 'studyFirstPostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset', 'timeFrame': 'Up to Month 48', 'description': 'GMTs of neutralizing antibodies were measured by microneutralization test 50% \\[MNT50\\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Data reported for up to Month 48 was collected at Months 1, 3, 6, 12, 13, 18, 24, 36 and 48.'}], 'secondaryOutcomes': [{'measure': 'Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset', 'timeFrame': 'Months 1, 3, 6, 12, 13, 18, 24, 36, and 48', 'description': 'Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10 (for each serotype). The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.'}, {'measure': 'Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination', 'timeFrame': 'Within 7 days after each vaccination', 'description': 'Solicited local injection included pain, erythema at injection site, and swelling at injection site. They were collected using a diary and graded as \\[Grade 0 (no pain), 1 (mild: minor reaction to touch), 2 (moderate: cries/protests on touch) and 3 (severe: cries when limb is moved/spontaneously painful)\\]. Erythema and Swelling at injection site were graded as Grade 0 (\\<10 mm), 1 (mild: ≥10 - ≤ 20 mm), 2 (moderate: \\> 20 - ≤ 40 mm) and 3 (severe: \\> 40 mm).'}, {'measure': 'Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination', 'timeFrame': 'Within 7 days after each vaccination', 'description': 'Solicited local injection site reactions were collected by participant diary and graded as \\[Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)\\]. Erythema and Swelling at injection site were graded as Grade 0 (\\<25 mm), 1 (mild: ≥25 - ≤ 50 mm), 2 (moderate: \\> 50 - ≤ 100 mm).'}, {'measure': 'Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination', 'timeFrame': 'Within 14 days after each vaccination', 'description': 'Solicited systemic AEs were collected within 14 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it.'}, {'measure': 'Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination', 'timeFrame': 'Within 14 days after each vaccination', 'description': 'Solicited systemic AEs were collected by participants within 14 days after vaccination and included headache, asthenia, malaise, myalgia and fever. Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it.'}, {'measure': 'Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination', 'timeFrame': 'Within 28 days after each vaccination', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.'}, {'measure': 'Percentage of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'From first vaccination through end of study (Day 1460)', 'description': 'An SAE was defined as any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above-mentioned criteria.'}, {'measure': 'Percentage of Participants With Febrile Episodes of Virologically Confirmed Dengue With Onset 30 Days Post-first Vaccination', 'timeFrame': 'From 30 days post-first vaccination through end of study (Day 1460)', 'description': 'Participants with febrile illness (defined as temperature ≥ 38°C on 2 consecutive days) were evaluated for dengue. A dengue infection was considered virologically confirmed by either positive polymerase chain reaction (PCR) or NS1 enzyme-linked immunosorbent assay (ELISA). Virologically confirmed dengue with onset 30 days after first vaccination within each group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Dengue Fever']}, 'referencesModule': {'references': [{'pmid': '40099800', 'type': 'DERIVED', 'citation': 'Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.'}, {'pmid': '35078666', 'type': 'DERIVED', 'citation': "Tricou V, Gottardo R, Egan MA, Clement F, Leroux-Roels G, Saez-Llorens X, Borkowski A, Wallace D, Dean HJ. Characterization of the cell-mediated immune response to Takeda's live-attenuated tetravalent dengue vaccine in adolescents participating in a phase 2 randomized controlled trial conducted in a dengue-endemic setting. Vaccine. 2022 Feb 16;40(8):1143-1151. doi: 10.1016/j.vaccine.2022.01.016. Epub 2022 Jan 22."}, {'pmid': '33534885', 'type': 'DERIVED', 'citation': 'Tsuji I, Dominguez D, Egan MA, Dean HJ. Development of a Novel Assay to Assess the Avidity of Dengue Virus-Specific Antibodies Elicited in Response to a Tetravalent Dengue Vaccine. J Infect Dis. 2022 May 4;225(9):1533-1544. doi: 10.1093/infdis/jiab064.'}, {'pmid': '32197107', 'type': 'DERIVED', 'citation': 'Tricou V, Saez-Llorens X, Yu D, Rivera L, Jimeno J, Villarreal AC, Dato E, Saldana de Suman O, Montenegro N, DeAntonio R, Mazara S, Vargas M, Mendoza D, Rauscher M, Brose M, Lefevre I, Tuboi S, Borkowski A, Wallace D. Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2-17 years: a randomised, placebo-controlled, phase 2 trial. Lancet. 2020 May 2;395(10234):1434-1443. doi: 10.1016/S0140-6736(20)30556-0. Epub 2020 Mar 17.'}, {'pmid': '29122463', 'type': 'DERIVED', 'citation': 'Saez-Llorens X, Tricou V, Yu D, Rivera L, Jimeno J, Villarreal AC, Dato E, Mazara S, Vargas M, Brose M, Rauscher M, Tuboi S, Borkowski A, Wallace D. Immunogenicity and safety of one versus two doses of tetravalent dengue vaccine in healthy children aged 2-17 years in Asia and Latin America: 18-month interim data from a phase 2, randomised, placebo-controlled study. Lancet Infect Dis. 2018 Feb;18(2):162-170. doi: 10.1016/S1473-3099(17)30632-1. Epub 2017 Nov 6.'}, {'pmid': '28365225', 'type': 'DERIVED', 'citation': "Saez-Llorens X, Tricou V, Yu D, Rivera L, Tuboi S, Garbes P, Borkowski A, Wallace D. Safety and immunogenicity of one versus two doses of Takeda's tetravalent dengue vaccine in children in Asia and Latin America: interim results from a phase 2, randomised, placebo-controlled study. Lancet Infect Dis. 2017 Jun;17(6):615-625. doi: 10.1016/S1473-3099(17)30166-4. Epub 2017 Mar 30."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the humoral immune responses to three different dose schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) administered subcutaneously in healthy participants between 2 and \\<18 years of age living in dengue endemic countries.", 'detailedDescription': "The vaccine tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV) which was administered in 3 different dosing schedules to participants aged from 2 to 17 years resident in dengue endemic countries. This study looked at the titers of antibodies to dengue fever elicited in people who received TDV.\n\nThe study randomized 1800 healthy participants. Participants were randomly assigned to one of the four treatment groups in a 1:2:5:1 ratio-which remained undisclosed to the participant and study doctor during the study (unless there was an urgent medical need):\n\n* Group 1 - TDV 0.5 mL subcutaneous (SC) injection Days 1 and 91\n* Group 2 - TDV 0.5 mL SC injection Day 1\n* Group 3 - TDV 0.5 mL SC injection Days 1 and 365\n* Group 4 - Placebo (dummy SC) - this is a liquid that looks like the study drug but has no active ingredient\n\nA total of 600 participants were planned to be randomly included in immunogenicity analyses (approximately 100 participants planned in each of Group 1 and Group 4, and 200 participants planned in each of Group 2 and Group 3).\n\nIn order to keep the treatment arms undisclosed to the participant and the doctor, participants received a placebo injection at any study visit where TDV was not being administered (Days 1 and/or 91 and/or 365).\n\nParticipants were asked to record any symptoms that may be related to the vaccine or the injection site in a diary card for 28 days after each vaccination.\n\nThis multi-center trial was conducted in Asia and Latin America. Participants were followed for 48 months with 10 protocol-scheduled visits for participants included in the planned immunogenicity subset of approximately 600 subjects and 7 protocol-scheduled visits for subjects not included in the immunogenicity subset."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Is aged 2 to \\<18 years, at the time of enrolment.\n2. Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator.\n3. The participant or, when applicable, the participant\'s legally acceptable representative signs and dates a written, informed consent form (and assent form, where required) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.\n4. Can comply with trial procedures and are available for the duration of follow-up.\n\nExclusion Criteria:\n\n1. Febrile illness (temperature ≥ 38°C or 100.4°F) or moderate or severe acute illness or infection at the time of enrolment. Trial entry should be delayed until the illness has improved.\n2. Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial, including but not limited to: a. Known hypersensitivity or allergy to any of the vaccine components; b. Female participants who are pregnant or breastfeeding; c. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin-dependent diabetes, cardiac, renal or hepatic disease, neurologic or seizure disorder or Guillain-Barré syndrome); d. Known or suspected impairment/alteration of immune function, including: i. Chronic use of oral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2 mg/kg body weight / day prednisone ≥ 2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed); ii. Receipt of parenteral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2 mg/kg body weight / day prednisone ≥ 2 weeks) within 60 days prior to Day 1; iii. Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the investigational vaccine or planned administration during the trial; iv. Receipt of immunostimulants within 60 days prior to Day 1; v. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months preceding (first) vaccination; vi. Human immunodeficiency virus (HIV) infection or HIV-related disease; vii. Genetic immunodeficiency.\n3. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of investigational vaccine administration.\n4. Individuals participating in any clinical trial with another investigational product 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial.\n5. Individuals who are first degree relatives of individuals involved in trial conduct.\n6. If female of childbearing potential, sexually active, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to trial entry: a. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal (for at least 2 years), bilateral tubal ligation (at least 1 year previously), bilateral oophorectomy (at least 1 year previously) or hysterectomy; b. Acceptable birth control methods are defined as one or more of the following: i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring); ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse; iii. Intrauterine device (IUD); iv. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the participants\' trial entry.\n7. If female of childbearing potential, sexually active and refuses to use an "acceptable contraceptive method" through to 6 weeks after the last dose of investigational vaccine.\n8. Individuals who participated in a previous dengue vaccine trial.'}, 'identificationModule': {'nctId': 'NCT02302066', 'briefTitle': "Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Participants", 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': "A Phase II, Double-Blind, Controlled Trial to Assess the Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Subjects Aged Between 2 and <18 Years and Living in Dengue Endemic Countries in Asia and Latin America", 'orgStudyIdInfo': {'id': 'DEN-204'}, 'secondaryIdInfos': [{'id': 'PHRR140804-000219', 'type': 'REGISTRY', 'domain': 'PHRR'}, {'id': 'U1111-1154-2475', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': '2018-003978-28', 'type': 'REGISTRY', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (TDV 2-Dose)', 'description': "Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching vaccine, 0.5 mL, subcutaneous injection on Day 365.", 'interventionNames': ["Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)", 'Biological: TDV Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (TDV 1-Dose)', 'description': "Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Day 1. Placebo-matching vaccine, 0.5 mL, subcutaneous injection on Days 91 and 365.", 'interventionNames': ["Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)", 'Biological: TDV Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 (TDV 1-Dose + Booster)', 'description': "Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching vaccine, 0.5 mL, subcutaneous injection on Day 91.", 'interventionNames': ["Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)", 'Biological: TDV Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 4 (Placebo Control)', 'description': 'Placebo-matching vaccine, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.', 'interventionNames': ['Biological: TDV Placebo']}], 'interventions': [{'name': "Takeda's Tetravalent Dengue Vaccine Candidate (TDV)", 'type': 'BIOLOGICAL', 'description': 'TDV subcutaneous injection', 'armGroupLabels': ['Group 1 (TDV 2-Dose)', 'Group 2 (TDV 1-Dose)', 'Group 3 (TDV 1-Dose + Booster)']}, {'name': 'TDV Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo-matching vaccine', 'armGroupLabels': ['Group 1 (TDV 2-Dose)', 'Group 2 (TDV 1-Dose)', 'Group 3 (TDV 1-Dose + Booster)', 'Group 4 (Placebo Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10204', 'city': 'Santo Domingo', 'state': 'Distrito Nacional Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Hospital Maternidad Nuestra Senora de la Altagracia', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'zip': '10662', 'city': 'Panama City', 'country': 'Panama', 'facility': 'Centro De Vacunacion Internacional, S.A.(CEVAXIN)', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'zip': '4114', 'city': 'Dasmariñas', 'state': 'Cavite', 'country': 'Philippines', 'facility': 'Dela Salle Health Sciences Institute', 'geoPoint': {'lat': 14.32944, 'lon': 120.93667}}], 'overallOfficials': [{'name': 'Program Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Takeda makes patient/subject-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}