Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT00979602
Status:
COMPLETED
Last Update Posted:
2018-03-21
First Post:
2009-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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 local and general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 42-day (Days 0-41) post-vaccination period. Serious adverse events (SAE): during the entire study period (Day 0 to Day 385).', 'eventGroups': [{'id': 'EG000', 'title': 'GSK2340274A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.', 'otherNumAtRisk': 2025, 'deathsNumAtRisk': 2025, 'otherNumAffected': 1680, 'seriousNumAtRisk': 2025, 'deathsNumAffected': 6, 'seriousNumAffected': 84}, {'id': 'EG001', 'title': 'GSK2340273A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.', 'otherNumAtRisk': 2023, 'deathsNumAtRisk': 2023, 'otherNumAffected': 1063, 'seriousNumAtRisk': 2023, 'deathsNumAffected': 1, 'seriousNumAffected': 73}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 302, 'numAffected': 299}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 167, 'numAffected': 165}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 183, 'numAffected': 181}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 116, 'numAffected': 116}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 82, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 112, 'numAffected': 110}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 114, 'numAffected': 114}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 573, 'numAffected': 564}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 435, 'numAffected': 428}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 570, 'numAffected': 547}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 530, 'numAffected': 510}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 116, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 83, 'numAffected': 83}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 709, 'numAffected': 698}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 329, 'numAffected': 326}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 124, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 131, 'numAffected': 126}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1533, 'numAffected': 1530}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 509, 'numAffected': 508}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 165, 'numAffected': 165}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Splenic vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastric fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Mesenteric vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Retroperitoneal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Enterocolitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Histoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia primary atypical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drug toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Brain natriuretic peptide increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Electrocardiogram st segment elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Enzyme activity decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchioloalveolar carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Follicle centre lymphoma, follicular grade i, ii, iii stage iii', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Glioblastoma multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': "Paget's disease of the breast", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thymoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abortion spontaneous complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pre-eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Small for dates baby', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urethral perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Stevens-johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2025, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2023, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1345', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '1338', 'groupId': 'OG002'}, {'value': '531', 'groupId': 'OG003'}, {'value': '1426', 'groupId': 'OG004'}, {'value': '454', 'groupId': 'OG005'}, {'value': '1414', 'groupId': 'OG006'}, {'value': '455', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1210', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}, {'value': '1012', 'groupId': 'OG002'}, {'value': '301', 'groupId': 'OG003'}, {'value': '1279', 'groupId': 'OG004'}, {'value': '342', 'groupId': 'OG005'}, {'value': '1055', 'groupId': 'OG006'}, {'value': '258', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 21', 'description': 'A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1347', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '1344', 'groupId': 'OG002'}, {'value': '532', 'groupId': 'OG003'}, {'value': '1428', 'groupId': 'OG004'}, {'value': '454', 'groupId': 'OG005'}, {'value': '1420', 'groupId': 'OG006'}, {'value': '456', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '337', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}, {'value': '350', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}, {'value': '346', 'groupId': 'OG006'}, {'value': '78', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.'}, {'type': 'PRIMARY', 'title': 'Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1350', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}, {'value': '1347', 'groupId': 'OG002'}, {'value': '533', 'groupId': 'OG003'}, {'value': '1432', 'groupId': 'OG004'}, {'value': '457', 'groupId': 'OG005'}, {'value': '1424', 'groupId': 'OG006'}, {'value': '456', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1326', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}, {'value': '1246', 'groupId': 'OG002'}, {'value': '371', 'groupId': 'OG003'}, {'value': '1403', 'groupId': 'OG004'}, {'value': '393', 'groupId': 'OG005'}, {'value': '1302', 'groupId': 'OG006'}, {'value': '315', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 21', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.'}, {'type': 'PRIMARY', 'title': 'Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1345', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '1338', 'groupId': 'OG002'}, {'value': '531', 'groupId': 'OG003'}, {'value': '1426', 'groupId': 'OG004'}, {'value': '454', 'groupId': 'OG005'}, {'value': '1414', 'groupId': 'OG006'}, {'value': '455', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000', 'lowerLimit': '25.7', 'upperLimit': '29.9'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '13.9'}, {'value': '15.5', 'groupId': 'OG002', 'lowerLimit': '14.2', 'upperLimit': '16.8'}, {'value': '6.4', 'groupId': 'OG003', 'lowerLimit': '5.7', 'upperLimit': '7.1'}, {'value': '26.9', 'groupId': 'OG004', 'lowerLimit': '25.0', 'upperLimit': '29.0'}, {'value': '11.9', 'groupId': 'OG005', 'lowerLimit': '10.5', 'upperLimit': '13.4'}, {'value': '14.8', 'groupId': 'OG006', 'lowerLimit': '13.6', 'upperLimit': '16.1'}, {'value': '6.3', 'groupId': 'OG007', 'lowerLimit': '5.5', 'upperLimit': '7.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 21', 'description': 'SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.', 'unitOfMeasure': 'Fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.'}, {'type': 'PRIMARY', 'title': 'Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1949', 'groupId': 'OG000'}, {'value': '1958', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340273A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 14 post-vaccination up to study end (at Day 385)', 'description': 'The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1350', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}, {'value': '1347', 'groupId': 'OG002'}, {'value': '533', 'groupId': 'OG003'}, {'value': '1432', 'groupId': 'OG004'}, {'value': '457', 'groupId': 'OG005'}, {'value': '1424', 'groupId': 'OG006'}, {'value': '456', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'Flu A/CAL/7/09, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1347', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '1344', 'groupId': 'OG002'}, {'value': '532', 'groupId': 'OG003'}, {'value': '1428', 'groupId': 'OG004'}, {'value': '454', 'groupId': 'OG005'}, {'value': '1420', 'groupId': 'OG006'}, {'value': '456', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '754', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '731', 'groupId': 'OG002'}, {'value': '312', 'groupId': 'OG003'}, {'value': '803', 'groupId': 'OG004'}, {'value': '244', 'groupId': 'OG005'}, {'value': '775', 'groupId': 'OG006'}, {'value': '268', 'groupId': 'OG007'}]}]}, {'title': 'Flu A/CAL/7/09, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1350', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}, {'value': '1347', 'groupId': 'OG002'}, {'value': '533', 'groupId': 'OG003'}, {'value': '1432', 'groupId': 'OG004'}, {'value': '457', 'groupId': 'OG005'}, {'value': '1424', 'groupId': 'OG006'}, {'value': '456', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1348', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '1335', 'groupId': 'OG002'}, {'value': '512', 'groupId': 'OG003'}, {'value': '1430', 'groupId': 'OG004'}, {'value': '452', 'groupId': 'OG005'}, {'value': '1410', 'groupId': 'OG006'}, {'value': '437', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 0 and 21', 'description': 'Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination.\n\nThe Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.'}, {'type': 'SECONDARY', 'title': 'Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1350', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}, {'value': '1347', 'groupId': 'OG002'}, {'value': '533', 'groupId': 'OG003'}, {'value': '1432', 'groupId': 'OG004'}, {'value': '457', 'groupId': 'OG005'}, {'value': '1424', 'groupId': 'OG006'}, {'value': '456', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'Flu A/CAL/7/09, Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1347', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '1344', 'groupId': 'OG002'}, {'value': '532', 'groupId': 'OG003'}, {'value': '1428', 'groupId': 'OG004'}, {'value': '454', 'groupId': 'OG005'}, {'value': '1420', 'groupId': 'OG006'}, {'value': '456', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '16.0'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '11.9'}, {'value': '14.8', 'groupId': 'OG002', 'lowerLimit': '13.8', 'upperLimit': '15.8'}, {'value': '12.2', 'groupId': 'OG003', 'lowerLimit': '11.2', 'upperLimit': '13.3'}, {'value': '14.7', 'groupId': 'OG004', 'lowerLimit': '13.8', 'upperLimit': '15.7'}, {'value': '10.9', 'groupId': 'OG005', 'lowerLimit': '10.0', 'upperLimit': '11.9'}, {'value': '14.7', 'groupId': 'OG006', 'lowerLimit': '13.7', 'upperLimit': '15.7'}, {'value': '12.0', 'groupId': 'OG007', 'lowerLimit': '11.0', 'upperLimit': '13.2'}]}]}, {'title': 'Flu A/CAL/7/09, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1350', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}, {'value': '1347', 'groupId': 'OG002'}, {'value': '533', 'groupId': 'OG003'}, {'value': '1432', 'groupId': 'OG004'}, {'value': '457', 'groupId': 'OG005'}, {'value': '1424', 'groupId': 'OG006'}, {'value': '456', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '415.0', 'groupId': 'OG000', 'lowerLimit': '391.4', 'upperLimit': '440.0'}, {'value': '135.9', 'groupId': 'OG001', 'lowerLimit': '122.1', 'upperLimit': '151.1'}, {'value': '228.7', 'groupId': 'OG002', 'lowerLimit': '213.5', 'upperLimit': '245.0'}, {'value': '77.3', 'groupId': 'OG003', 'lowerLimit': '68.4', 'upperLimit': '87.4'}, {'value': '396.2', 'groupId': 'OG004', 'lowerLimit': '373.8', 'upperLimit': '419.9'}, {'value': '128.6', 'groupId': 'OG005', 'lowerLimit': '114.6', 'upperLimit': '144.3'}, {'value': '217.6', 'groupId': 'OG006', 'lowerLimit': '203.3', 'upperLimit': '232.9'}, {'value': '75.2', 'groupId': 'OG007', 'lowerLimit': '65.9', 'upperLimit': '85.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 0 and 21', 'description': 'Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '43', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 42', 'description': 'Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.'}, {'type': 'SECONDARY', 'title': 'Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '288.5', 'groupId': 'OG000', 'lowerLimit': '215.9', 'upperLimit': '385.5'}, {'value': '105.4', 'groupId': 'OG001', 'lowerLimit': '70.8', 'upperLimit': '157.0'}, {'value': '177.2', 'groupId': 'OG002', 'lowerLimit': '121.3', 'upperLimit': '259.0'}, {'value': '47.9', 'groupId': 'OG003', 'lowerLimit': '33.1', 'upperLimit': '69.2'}, {'value': '276.5', 'groupId': 'OG004', 'lowerLimit': '207.1', 'upperLimit': '369.0'}, {'value': '105.9', 'groupId': 'OG005', 'lowerLimit': '70.2', 'upperLimit': '159.9'}, {'value': '170.0', 'groupId': 'OG006', 'lowerLimit': '117.7', 'upperLimit': '245.4'}, {'value': '47.2', 'groupId': 'OG007', 'lowerLimit': '32.1', 'upperLimit': '69.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 42', 'description': 'Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1306', 'groupId': 'OG000'}, {'value': '543', 'groupId': 'OG001'}, {'value': '1314', 'groupId': 'OG002'}, {'value': '536', 'groupId': 'OG003'}, {'value': '1388', 'groupId': 'OG004'}, {'value': '461', 'groupId': 'OG005'}, {'value': '1391', 'groupId': 'OG006'}, {'value': '459', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1282', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}, {'value': '1257', 'groupId': 'OG002'}, {'value': '449', 'groupId': 'OG003'}, {'value': '1361', 'groupId': 'OG004'}, {'value': '422', 'groupId': 'OG005'}, {'value': '1324', 'groupId': 'OG006'}, {'value': '382', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 182', 'description': 'Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.'}, {'type': 'SECONDARY', 'title': 'Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1306', 'groupId': 'OG000'}, {'value': '543', 'groupId': 'OG001'}, {'value': '1314', 'groupId': 'OG002'}, {'value': '536', 'groupId': 'OG003'}, {'value': '1388', 'groupId': 'OG004'}, {'value': '461', 'groupId': 'OG005'}, {'value': '1391', 'groupId': 'OG006'}, {'value': '459', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '115.5', 'groupId': 'OG000', 'lowerLimit': '107.8', 'upperLimit': '123.7'}, {'value': '38.4', 'groupId': 'OG001', 'lowerLimit': '34.6', 'upperLimit': '42.6'}, {'value': '87.6', 'groupId': 'OG002', 'lowerLimit': '81.4', 'upperLimit': '94.3'}, {'value': '30.1', 'groupId': 'OG003', 'lowerLimit': '26.9', 'upperLimit': '33.6'}, {'value': '109.5', 'groupId': 'OG004', 'lowerLimit': '102.3', 'upperLimit': '117.1'}, {'value': '37.1', 'groupId': 'OG005', 'lowerLimit': '33.2', 'upperLimit': '41.5'}, {'value': '83.3', 'groupId': 'OG006', 'lowerLimit': '77.5', 'upperLimit': '89.5'}, {'value': '29.2', 'groupId': 'OG007', 'lowerLimit': '26.0', 'upperLimit': '33.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 182', 'description': 'Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 42', 'description': 'A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}, {'value': '1304', 'groupId': 'OG002'}, {'value': '534', 'groupId': 'OG003'}, {'value': '1383', 'groupId': 'OG004'}, {'value': '458', 'groupId': 'OG005'}, {'value': '1380', 'groupId': 'OG006'}, {'value': '458', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '823', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '717', 'groupId': 'OG002'}, {'value': '146', 'groupId': 'OG003'}, {'value': '861', 'groupId': 'OG004'}, {'value': '160', 'groupId': 'OG005'}, {'value': '741', 'groupId': 'OG006'}, {'value': '122', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 182', 'description': 'A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '43', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 42', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.'}, {'type': 'SECONDARY', 'title': 'Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1306', 'groupId': 'OG000'}, {'value': '543', 'groupId': 'OG001'}, {'value': '1314', 'groupId': 'OG002'}, {'value': '536', 'groupId': 'OG003'}, {'value': '1388', 'groupId': 'OG004'}, {'value': '461', 'groupId': 'OG005'}, {'value': '1391', 'groupId': 'OG006'}, {'value': '459', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1091', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}, {'value': '1009', 'groupId': 'OG002'}, {'value': '236', 'groupId': 'OG003'}, {'value': '1140', 'groupId': 'OG004'}, {'value': '237', 'groupId': 'OG005'}, {'value': '1047', 'groupId': 'OG006'}, {'value': '198', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 182', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '35.8'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '16.0'}, {'value': '13.7', 'groupId': 'OG002', 'lowerLimit': '9.1', 'upperLimit': '20.6'}, {'value': '4.0', 'groupId': 'OG003', 'lowerLimit': '2.9', 'upperLimit': '5.5'}, {'value': '26.1', 'groupId': 'OG004', 'lowerLimit': '19.7', 'upperLimit': '34.6'}, {'value': '11.0', 'groupId': 'OG005', 'lowerLimit': '7.5', 'upperLimit': '16.1'}, {'value': '13.2', 'groupId': 'OG006', 'lowerLimit': '8.8', 'upperLimit': '19.7'}, {'value': '3.9', 'groupId': 'OG007', 'lowerLimit': '2.9', 'upperLimit': '5.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 42', 'description': 'SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.', 'unitOfMeasure': 'Fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available.'}, {'type': 'SECONDARY', 'title': 'Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1302', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}, {'value': '1304', 'groupId': 'OG002'}, {'value': '534', 'groupId': 'OG003'}, {'value': '1383', 'groupId': 'OG004'}, {'value': '458', 'groupId': 'OG005'}, {'value': '1380', 'groupId': 'OG006'}, {'value': '458', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-60 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 60 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>60 y) Group', 'description': 'Healthy male or female subjects older than 60 years of age (\\>60 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG004', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG005', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG006', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG007', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '8.4'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '3.9'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '5.4', 'upperLimit': '6.4'}, {'value': '2.5', 'groupId': 'OG003', 'lowerLimit': '2.3', 'upperLimit': '2.8'}, {'value': '7.5', 'groupId': 'OG004', 'lowerLimit': '6.9', 'upperLimit': '8.1'}, {'value': '3.4', 'groupId': 'OG005', 'lowerLimit': '3.0', 'upperLimit': '3.8'}, {'value': '5.6', 'groupId': 'OG006', 'lowerLimit': '5.2', 'upperLimit': '6.1'}, {'value': '2.5', 'groupId': 'OG007', 'lowerLimit': '2.2', 'upperLimit': '2.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 182', 'description': 'SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.', 'unitOfMeasure': 'Fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available.'}, {'type': 'SECONDARY', 'title': 'Number of A/California Influenza Related Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1949', 'groupId': 'OG000'}, {'value': '1958', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340273A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'ILI cases', 'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia cases', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'RT-qPCR confirmed influenza', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Culture confirmed influenza', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'RT-qPCR confirmed influenza with pneumonia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 0 up to the end of ILI surveillance (Day 385)', 'description': 'Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.'}, {'type': 'SECONDARY', 'title': 'Number of ILI Symptoms in All Reported ILI Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1949', 'groupId': 'OG000'}, {'value': '1958', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340273A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'Fever', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}]}, {'title': 'Sore throat', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}, {'title': 'Runny or stuffy nose', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}, {'title': 'Short of breath', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 0 up to the end of ILI surveillance (Day 385)', 'description': 'Assessed ILI symptoms were fever \\[defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)\\], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.'}, {'type': 'SECONDARY', 'title': 'Number of ILI Symptoms in All Reported ILI Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1949', 'groupId': 'OG000'}, {'value': '1958', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340273A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'Fever', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}, {'title': 'Sore throat', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}, {'title': 'Runny or stuffy nose', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Short of breath', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 14 post-vaccination through the end of ILI surveillance (Day 385)', 'description': 'Assessed ILI symptoms were fever \\[defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)\\], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1529', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '1531', 'groupId': 'OG002'}, {'value': '479', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'Any Pain', 'categories': [{'measurements': [{'value': '1256', 'groupId': 'OG000'}, {'value': '272', 'groupId': 'OG001'}, {'value': '458', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Pain', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Redness', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Redness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\\>64y).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1529', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '1531', 'groupId': 'OG002'}, {'value': '479', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'Any Fatigue', 'categories': [{'measurements': [{'value': '473', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Fatigue', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related Fatigue', 'categories': [{'measurements': [{'value': '382', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}]}, {'title': 'Any Headache', 'categories': [{'measurements': [{'value': '452', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '421', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Headache', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Related Headache', 'categories': [{'measurements': [{'value': '359', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '312', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}, {'title': 'Any Joint pain', 'categories': [{'measurements': [{'value': '242', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Joint pain', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Related Joint pain', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'Any Muscle aches', 'categories': [{'measurements': [{'value': '600', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Muscle aches', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Related Muscle aches', 'categories': [{'measurements': [{'value': '531', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '240', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}, {'title': 'Any Shivering', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Shivering', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related Shivering', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Any Sweating', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Sweating', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related Sweating', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Any Temperature', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Temperature', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Related Temperature', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period', 'description': 'Assessed solicited general symptoms were fatigue, fever \\[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\\], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\\>64y).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who filled in their symptom sheets.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1527', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1524', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'title': 'ALT, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1527', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1524', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1497', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}, {'value': '1482', 'groupId': 'OG002'}, {'value': '472', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'ALT, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1455', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '1437', 'groupId': 'OG002'}, {'value': '469', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'AP, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1527', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1523', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1497', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '1495', 'groupId': 'OG002'}, {'value': '468', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'AP, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1461', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '1469', 'groupId': 'OG002'}, {'value': '464', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'AST, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1527', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1524', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1505', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}, {'value': '1493', 'groupId': 'OG002'}, {'value': '473', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'AST, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1466', 'groupId': 'OG000'}, {'value': '472', 'groupId': 'OG001'}, {'value': '1459', 'groupId': 'OG002'}, {'value': '468', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'BAS, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1526', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1523', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1511', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}, {'value': '1515', 'groupId': 'OG002'}, {'value': '477', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'BAS, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1458', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '1460', 'groupId': 'OG002'}, {'value': '466', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'T/BIL, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1527', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1524', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1511', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}, {'value': '1500', 'groupId': 'OG002'}, {'value': '472', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'T/BIL, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1467', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}, {'value': '1466', 'groupId': 'OG002'}, {'value': '467', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'BIL/D, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1527', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1524', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1524', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}, {'value': '1518', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'BIL/D, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1484', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1488', 'groupId': 'OG002'}, {'value': '473', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CREA, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1527', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1523', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1365', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}, {'value': '1363', 'groupId': 'OG002'}, {'value': '443', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'CREA, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1324', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}, {'value': '1345', 'groupId': 'OG002'}, {'value': '438', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'EOS, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1526', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1523', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1411', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}, {'value': '1414', 'groupId': 'OG002'}, {'value': '449', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'EOS, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1345', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}, {'value': '1361', 'groupId': 'OG002'}, {'value': '437', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'HEM, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1526', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1523', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1429', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '1416', 'groupId': 'OG002'}, {'value': '467', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'HEM, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1368', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}, {'value': '1362', 'groupId': 'OG002'}, {'value': '453', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'HgB, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1526', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1523', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1455', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}, {'value': '1436', 'groupId': 'OG002'}, {'value': '470', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'HgB, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1399', 'groupId': 'OG000'}, {'value': '460', 'groupId': 'OG001'}, {'value': '1385', 'groupId': 'OG002'}, {'value': '456', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'LYM, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1526', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1523', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1494', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}, {'value': '1500', 'groupId': 'OG002'}, {'value': '468', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'LYM, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1445', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}, {'value': '1444', 'groupId': 'OG002'}, {'value': '452', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'MON, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1526', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1523', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '306', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1205', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}, {'value': '1224', 'groupId': 'OG002'}, {'value': '423', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'MON, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '309', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '304', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1149', 'groupId': 'OG000'}, {'value': '404', 'groupId': 'OG001'}, {'value': '1155', 'groupId': 'OG002'}, {'value': '402', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'NEU, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1522', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}, {'value': '1522', 'groupId': 'OG002'}, {'value': '475', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1449', 'groupId': 'OG000'}, {'value': '454', 'groupId': 'OG001'}, {'value': '1448', 'groupId': 'OG002'}, {'value': '459', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'NEU, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1392', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}, {'value': '1392', 'groupId': 'OG002'}, {'value': '448', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'PLA, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1526', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1523', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1498', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}, {'value': '1501', 'groupId': 'OG002'}, {'value': '467', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'PLA, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1454', 'groupId': 'OG000'}, {'value': '456', 'groupId': 'OG001'}, {'value': '1448', 'groupId': 'OG002'}, {'value': '456', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1526', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1523', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1411', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '1402', 'groupId': 'OG002'}, {'value': '469', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'RBC, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1368', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}, {'value': '1367', 'groupId': 'OG002'}, {'value': '458', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'BUN, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1527', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1523', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1509', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}, {'value': '1500', 'groupId': 'OG002'}, {'value': '466', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'BUN, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1462', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}, {'value': '1467', 'groupId': 'OG002'}, {'value': '469', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1526', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '1523', 'groupId': 'OG002'}, {'value': '478', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1457', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}, {'value': '1440', 'groupId': 'OG002'}, {'value': '458', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'WBC, Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1493', 'groupId': 'OG000'}, {'value': '473', 'groupId': 'OG001'}, {'value': '1492', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Unknown', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Below', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}, {'title': 'Within', 'measurements': [{'value': '1406', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '1398', 'groupId': 'OG002'}, {'value': '444', 'groupId': 'OG003'}]}, {'title': 'Above', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Days 7 and 21', 'description': 'Among biochemical and haematological parameters assessed were alanine aminotransferase \\[ALT\\], alkaline phosphatase \\[AP\\], aspartate aminotransferase \\[AST\\], basophils \\[BAS\\], total bilirubin \\[T/BIL\\], bilirubin direct \\[BIL/D\\], creatinine \\[CREA\\], eosinophils \\[EOS\\], hematocrit \\[HEM\\], haemoglobin \\[Hgb\\], lymphocytes \\[LYM\\], monocytes \\[MON\\], neutrophils \\[NEU\\], platelets \\[PLA\\], red blood cells \\[RBC\\], blood urea nitrogen \\[BUN\\] and white blood cells \\[WBC\\]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above for subjects aged 18-64 years (18-64y) and \\>64 years old (\\>64y).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Medically-attended Adverse Events (MAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1544', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}, {'value': '1543', 'groupId': 'OG002'}, {'value': '480', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '615', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '614', 'groupId': 'OG002'}, {'value': '265', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the entire study period (Day 0 - Day 385)', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\\>64y).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1544', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}, {'value': '1543', 'groupId': 'OG002'}, {'value': '480', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the entire study period (Day 0 - Day 385)', 'description': 'Potential immune-mediated diseases (pIMDs) represent a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\\>64y).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1544', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}, {'value': '1543', 'groupId': 'OG002'}, {'value': '480', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '495', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '522', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within the 42-day (Days 0-41) post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\\>64y).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1544', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}, {'value': '1543', 'groupId': 'OG002'}, {'value': '480', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK2340274A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG001', 'title': 'GSK2340274A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG002', 'title': 'GSK2340273A (18-64 y) Group', 'description': 'Healthy male or female subjects between and including 18 and 64 years of age, who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'OG003', 'title': 'GSK2340273A (>64 y) Group', 'description': 'Healthy male or female subjects older than 64 years of age (\\>64 y), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the entire study period (Day 0 - Day 385)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\\>64y).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GSK2340274A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'FG001', 'title': 'GSK2340273A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2025'}, {'groupId': 'FG001', 'numSubjects': '2023'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1880'}, {'groupId': 'FG001', 'numSubjects': '1890'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '133'}]}], 'dropWithdraws': [{'type': 'Serious Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Others', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2025', 'groupId': 'BG000'}, {'value': '2023', 'groupId': 'BG001'}, {'value': '4048', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GSK2340274A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'BG001', 'title': 'GSK2340273A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '18.6', 'groupId': 'BG000'}, {'value': '45.4', 'spread': '18.3', 'groupId': 'BG001'}, {'value': '45.5', 'spread': '18.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1185', 'groupId': 'BG000'}, {'value': '1185', 'groupId': 'BG001'}, {'value': '2370', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '840', 'groupId': 'BG000'}, {'value': '838', 'groupId': 'BG001'}, {'value': '1678', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Geographic ancestry', 'categories': [{'title': 'African Heritage/African American', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaskan native', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Asian - Central/South Asian Heritage', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Asian - East Asian Heritage', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Asian - Japanese Heritage', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian - South East Asian Heritage', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White - Arabic/North African Heritage', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'White - Caucasian/European Heritage', 'measurements': [{'value': '1787', 'groupId': 'BG000'}, {'value': '1790', 'groupId': 'BG001'}, {'value': '3577', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4048}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'dispFirstSubmitDate': '2011-02-04', 'completionDateStruct': {'date': '2011-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-19', 'studyFirstSubmitDate': '2009-09-17', 'dispFirstSubmitQcDate': '2011-02-04', 'resultsFirstSubmitDate': '2017-08-25', 'studyFirstSubmitQcDate': '2009-09-17', 'dispFirstPostDateStruct': {'date': '2011-02-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-25', 'studyFirstPostDateStruct': {'date': '2009-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 21', 'description': 'A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.'}, {'measure': 'Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 0', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.'}, {'measure': 'Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 21', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.'}, {'measure': 'Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 21', 'description': 'SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance.'}, {'measure': 'Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases', 'timeFrame': 'From Day 14 post-vaccination up to study end (at Day 385)', 'description': 'The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases.'}], 'secondaryOutcomes': [{'measure': 'Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Days 0 and 21', 'description': 'Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination.\n\nThe Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.'}, {'measure': 'Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Days 0 and 21', 'description': 'Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.'}, {'measure': 'Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 42', 'description': 'Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.'}, {'measure': 'Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 42', 'description': 'Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.'}, {'measure': 'Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 182', 'description': 'Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.'}, {'measure': 'Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 182', 'description': 'Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.'}, {'measure': 'Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 42', 'description': 'A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.'}, {'measure': 'Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 182', 'description': 'A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer ≥1:40 and at least a 4-fold increase of the pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.'}, {'measure': 'Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 42', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.'}, {'measure': 'Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 182', 'description': 'A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance.'}, {'measure': 'Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 42', 'description': 'SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.'}, {'measure': 'Seroconversion Factor (SCF) for HI Antibodies Against A/CAL/7/09 H1N1 Virus Strain', 'timeFrame': 'At Day 182', 'description': 'SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP.'}, {'measure': 'Number of A/California Influenza Related Cases', 'timeFrame': 'From Day 0 up to the end of ILI surveillance (Day 385)', 'description': 'Influenza related cases included: A/California/7/2009 (H1N1)v-like influenza illness (ILI) cases, pneumonia cases, RT-qPCR confirmed influenza, culture confirmed influenza and RT-qPCR confirmed influenza with pneumonia.'}, {'measure': 'Number of ILI Symptoms in All Reported ILI Cases', 'timeFrame': 'From Day 0 up to the end of ILI surveillance (Day 385)', 'description': 'Assessed ILI symptoms were fever \\[defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)\\], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.'}, {'measure': 'Number of ILI Symptoms in All Reported ILI Cases', 'timeFrame': 'From Day 14 post-vaccination through the end of ILI surveillance (Day 385)', 'description': 'Assessed ILI symptoms were fever \\[defined as oral temperature equal to or above (≥) 38.5 degrees Celsius (°C)\\], myalgia (muscle aches all over the body), cough, sore throat, runny/stuffy nose, short of breath, headache, vomiting, diarrhea, chills, fatigue.'}, {'measure': 'Number of Subjects With Any and Grade 3 Solicited Local Symptoms', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period', 'description': 'Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\\>64y).'}, {'measure': 'Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms', 'timeFrame': 'During the 7-day (Days 0-6) post-vaccination period', 'description': 'Assessed solicited general symptoms were fatigue, fever \\[defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)\\], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\\>64y).'}, {'measure': 'Number of Subjects With Normal/Abnormal Biochemical and Haematological Levels', 'timeFrame': 'At Days 7 and 21', 'description': 'Among biochemical and haematological parameters assessed were alanine aminotransferase \\[ALT\\], alkaline phosphatase \\[AP\\], aspartate aminotransferase \\[AST\\], basophils \\[BAS\\], total bilirubin \\[T/BIL\\], bilirubin direct \\[BIL/D\\], creatinine \\[CREA\\], eosinophils \\[EOS\\], hematocrit \\[HEM\\], haemoglobin \\[Hgb\\], lymphocytes \\[LYM\\], monocytes \\[MON\\], neutrophils \\[NEU\\], platelets \\[PLA\\], red blood cells \\[RBC\\], blood urea nitrogen \\[BUN\\] and white blood cells \\[WBC\\]. Levels of haematological/biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above for subjects aged 18-64 years (18-64y) and \\>64 years old (\\>64y).'}, {'measure': 'Number of Subjects With Any Medically-attended Adverse Events (MAEs)', 'timeFrame': 'Throughout the entire study period (Day 0 - Day 385)', 'description': 'MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\\>64y).'}, {'measure': 'Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)', 'timeFrame': 'Throughout the entire study period (Day 0 - Day 385)', 'description': 'Potential immune-mediated diseases (pIMDs) represent a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\\>64y).'}, {'measure': 'Number of Subjects With Any Unsolicited Adverse Events (AEs)', 'timeFrame': 'Within the 42-day (Days 0-41) post-vaccination period', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\\>64y).'}, {'measure': 'Number of Subjects With Serious Adverse Events (SAEs)', 'timeFrame': 'Throughout the entire study period (Day 0 - Day 385)', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Safety results were tabulated according to age stratification: adults aged 18-64 years and older (\\>64y).'}]}, 'conditionsModule': {'keywords': ["GSK Bio's influenza vaccine GSK2340274A", 'Influenza Vaccines', "GSK Bio's influenza vaccine GSK2340273A", 'influenza infection'], 'conditions': ['Influenza']}, 'referencesModule': {'availIpds': [{'id': '113480', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113480', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113480', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113480', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113480', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113480', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113480', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '23856331', 'type': 'DERIVED', 'citation': 'Yang WH, Dionne M, Kyle M, Aggarwal N, Li P, Madariaga M, Godeaux O, Vaughn DW. Long-term immunogenicity of an AS03-adjuvanted influenza A(H1N1)pdm09 vaccine in young and elderly adults: an observer-blind, randomized trial. Vaccine. 2013 Sep 13;31(40):4389-97. doi: 10.1016/j.vaccine.2013.07.007. Epub 2013 Jul 12.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the safety, immunogenicity, and relative efficacy of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.', 'detailedDescription': 'Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes can and will comply with the requirements of the protocol.\n* Written informed consent obtained from the subject.\n* Male and female adults, \\>= 18 years of age at the time of the first vaccination.\n* Satisfactory baseline medical assessment by history and physical examination.\n* Safety laboratory test results within the parameters specified in the protocol.\n* Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as demonstrated by signature on the informed consent document.\n* Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device.\n* Female subjects of non-childbearing potential may be enrolled in the study.\n* Female subjects of childbearing potential may be enrolled in the study, if the subject:\n* has practiced adequate contraception for 30 days prior to vaccination; and\n* has a negative pregnancy test on the day of first vaccination; and\n* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.\n\nExclusion Criteria:\n\n* Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.\n* Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.\n* With the exception of seasonal influenza vaccination, administration of any vaccine(s) within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.\n* Planned administration of any vaccine other than the study vaccines between Day 0 and the phlebotomy 21 days after vaccination.\n* Planned administration of any monovalent pandemic (H1N1)v-like vaccine other than the study vaccines during the whole study (Day 0 - Day 385).\n* Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.\n* Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.\n* Presence of a temperature \\>= 38.0ºC (\\>= 100.4 ºF), oral temperature assessment preferred, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.\n* Diagnosed with cancer, or treatment for cancer, within 3 years.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n* Receipt of systemic glucocorticoids within 1month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors, or imiquimod are allowed.\n* Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.\n* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.\n* History of an acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.\n* With the exception of seasonal influenza vaccination, administration of any vaccines within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.\n* Planned administration of any vaccine other than the study vaccine between Day 0 and the phlebotomy 21 days after the second study vaccine dose.\n* Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period.\n* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.\n* Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to vaccination.\n* Lactating or nursing women.'}, 'identificationModule': {'nctId': 'NCT00979602', 'briefTitle': 'Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study to Evaluate the Safety, Immunogenicity, and Relative Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Adults Aged 18 Years and Older', 'orgStudyIdInfo': {'id': '113480'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK2340274A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the adjuvanted GSK2340274A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.', 'interventionNames': ['Biological: GSK2340274A']}, {'type': 'EXPERIMENTAL', 'label': 'GSK2340273A Group', 'description': 'Healthy male or female subjects between and including 18 to 60 years of age and older (\\>60 years) and between 18 to 64 years of age and older (\\>64 years), who received one dose of the unadjuvanted GSK2340273A vaccine at Day 0, administered intramuscularly into the deltoid region of the non-dominant arm.', 'interventionNames': ['Biological: GSK2340273A']}], 'interventions': [{'name': 'GSK2340274A', 'type': 'BIOLOGICAL', 'description': 'One intramuscular injection', 'armGroupLabels': ['GSK2340274A Group']}, {'name': 'GSK2340273A', 'type': 'BIOLOGICAL', 'description': 'One intramuscular injection', 'armGroupLabels': ['GSK2340273A Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85213', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85028', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33484', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '32205', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '60610', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21045', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '01757', 'city': 'Milford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.13982, 'lon': -71.51617}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '08244', 'city': 'Somers Point', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.31762, 'lon': -74.5946}}, {'zip': '13901', 'city': 'Binghamton', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.09869, 'lon': -75.91797}}, {'zip': '13031', 'city': 'Camillus', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.03923, 'lon': -76.3041}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44094', 'city': 'Willoughby Hills', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.59838, 'lon': -81.41845}}, {'zip': '16506', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98801', 'city': 'Wenatchee', 'state': 'Washington', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.42346, 'lon': -120.31035}}, {'zip': 'V3K 3P4', 'city': 'Coquitlam', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.2846, 'lon': -122.78217}}, {'zip': 'A0A 1G0', 'city': 'Bay Roberts', 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.59989, 'lon': -53.26478}}, {'zip': 'A1A 3R5', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'L6T 3T1', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'P3E 1H5', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'N5W 6A2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1Y 4G2', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M3H 5S4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'J8Y 6S8', 'city': 'Gatineau', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'zip': 'G1E 7G9', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1W 4R4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 1Z1', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'G6W 5M6', 'city': 'St-Romulad', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site'}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}