Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT02663102
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2016-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.', 'eventGroups': [{'id': 'EG000', 'title': 'Fluarix Tetra Group 1', 'description': 'Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).', 'otherNumAtRisk': 687, 'deathsNumAtRisk': 687, 'otherNumAffected': 167, 'seriousNumAtRisk': 687, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Fluarix Tetra Group 2', 'description': 'Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).', 'otherNumAtRisk': 701, 'deathsNumAtRisk': 701, 'otherNumAffected': 105, 'seriousNumAtRisk': 701, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 53, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Laryngopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dacryocystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Herpangina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myringitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 35, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Administration site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Administration site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Muscle spams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Traumatic arthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Xerophthalmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': "Kawasaki's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 687, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 701, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Expected Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'OG000'}, {'value': '701', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluarix Tetra Group 1', 'description': 'Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).'}, {'id': 'OG001', 'title': 'Fluarix Tetra Group 2', 'description': 'Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)', 'description': 'An adverse event that is expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety analysis set which included all subjects who received Fluarix Tetra, participated in the drug use investigation and provided post vaccination safety data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Unexpected Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'OG000'}, {'value': '701', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluarix Tetra Group 1', 'description': 'Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).'}, {'id': 'OG001', 'title': 'Fluarix Tetra Group 2', 'description': 'Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)', 'description': 'Any adverse event reported in addition to those expected during the drug use investigation. Adverse events that are not reflected in the approved Prescribing Information.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety analysis set which included all subjects who received Fluarix Tetra, participated in the drug use investigation and provided post vaccination safety data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'OG000'}, {'value': '701', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluarix Tetra Group 1', 'description': 'Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).'}, {'id': 'OG001', 'title': 'Fluarix Tetra Group 2', 'description': 'Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)', 'description': 'SAEs assessed included any adverse event that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety analysis set which included all subjects who received Fluarix Tetra, participated in the drug use investigation and provided post vaccination safety data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluarix Tetra Group 1', 'description': 'Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).'}, {'id': 'FG001', 'title': 'Fluarix Tetra Group 2', 'description': 'Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '687'}, {'groupId': 'FG001', 'numSubjects': '701'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '687'}, {'groupId': 'FG001', 'numSubjects': '701'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'BG000'}, {'value': '701', 'groupId': 'BG001'}, {'value': '1388', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluarix Tetra Group 1', 'description': 'Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).'}, {'id': 'BG001', 'title': 'Fluarix Tetra Group 2', 'description': 'Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '6 months - 11 months', 'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}, {'title': '>1 year - <2 years', 'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}, {'title': '>2 years - < 3 years', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': '3 years - 9 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': '10 years - 19 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': '20 years - 29 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': '30 years - 39 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': '40 years - 49 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': '50 years or more', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '323', 'groupId': 'BG000'}, {'value': '376', 'groupId': 'BG001'}, {'value': '699', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '364', 'groupId': 'BG000'}, {'value': '325', 'groupId': 'BG001'}, {'value': '689', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Korean', 'measurements': [{'value': '686', 'groupId': 'BG000'}, {'value': '701', 'groupId': 'BG001'}, {'value': '1387', 'groupId': 'BG002'}]}, {'title': 'Non-Korean', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-08', 'size': 2456271, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-11T04:20', 'hasProtocol': True}, {'date': '2021-09-29', 'size': 974504, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-11T04:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1388}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-16', 'studyFirstSubmitDate': '2016-01-21', 'resultsFirstSubmitDate': '2022-11-11', 'studyFirstSubmitQcDate': '2016-01-21', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-16', 'studyFirstPostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Expected Adverse Events (AEs)', 'timeFrame': 'During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)', 'description': 'An adverse event that is expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information.'}, {'measure': 'Number of Participants With Unexpected Adverse Events (AEs)', 'timeFrame': 'During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)', 'description': 'Any adverse event reported in addition to those expected during the drug use investigation. Adverse events that are not reflected in the approved Prescribing Information.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)', 'description': 'SAEs assessed included any adverse event that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject.'}]}, 'conditionsModule': {'keywords': ['Safety', 'Post-marketing', 'Korea', 'Drug utilization study', 'Fluarix Tetra'], 'conditions': ['Influenza, Human']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect safety information on the use of Fluarix Tetra according to the approved PI, in Korea, over a period of 6 years from children greater than or equal to (≥)3 years of age and adults, and over a period of 4 years from children between 6 months and 35 months of age.', 'detailedDescription': 'Adults and previously vaccinated children aged ≥6 months, a single dose of Fluarix Tetra will be administered. To previously unvaccinated children aged 6 months to less than (\\<) 9 years, two doses will be administered with a second dose at least 4 weeks apart from the first one as per the local PI in Korea.\n\nFluarix Tetra may be administered to pregnant women/lactating women as per PI, if there is a clear need. Pregnancy outcome (whether full-term or premature, information on the status of the mother and child) in vaccinated pregnant subjects will be followed-up at 6-8 weeks after delivery, if possible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects aged 6 months and above who were vaccinated with Fluarix Tetra or eligible to receive Fluarix Tetra in Korea according to the locally approved PI.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects who were vaccinated with Fluarix Tetra or eligible to receive Fluarix Tetra according to the locally approved PI.\n* Signed informed consent as Informed Consent Form (ICF)/Informed Assent Form (IAF) obtained from the subject/subject's parent(s)/Legally acceptable Representative(s) \\[LAR(s)\\].\n\nExclusion Criteria:\n\n* Those who are not eligible for vaccination with Fluarix Tetra according to the local PI.\n\n * Hypersensitivity reaction to Fluarix Tetra.\n * History of hypersensitivity reaction to Influenza vaccine.\n * History of Guillain-Barre syndrome or other nervous system abnormalities to Influenza vaccine within 6 weeks post-vaccination.\n* Those who are not eligible for vaccination with Fluarix Tetra according to the medical judgement of physician."}, 'identificationModule': {'nctId': 'NCT02663102', 'briefTitle': "Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Assessment of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information in Korea.", 'orgStudyIdInfo': {'id': '204687'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fluarix Tetra Group 1', 'description': 'Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).', 'interventionNames': ['Other: Data collection']}, {'label': 'Fluarix Tetra Group 2', 'description': 'Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Safety monitoring and evaluation: - Recording of all AEs during the study period using diary cards, follow-up contact via telephone or email. - Recording of SAEs throughout the study period for each subject.', 'armGroupLabels': ['Fluarix Tetra Group 1', 'Fluarix Tetra Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47545', 'city': 'Busan', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '42274', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '42601', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '700 712', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '25768', 'city': 'Donghae', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.43694, 'lon': 126.63417}}, {'zip': '484 5', 'city': 'Gwangmyeong', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.47722, 'lon': 126.86639}}, {'zip': '39230', 'city': 'Gyeongsangbuk-do', 'country': 'South Korea', 'facility': 'GSK Investigational Site'}, {'zip': '22214', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '03181', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03966', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04143', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04168', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06568', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08737', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-720', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138201', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '7499', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '16388', 'city': 'Suwon-si, Gyeonggi-do', 'country': 'South Korea', 'facility': 'GSK Investigational Site'}, {'zip': '683380', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'zip': '11456', 'city': 'Yangju-si, Gyeonggi-do', 'country': 'South Korea', 'facility': 'GSK Investigational Site'}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}