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Ignite Creation Date: 2025-12-24 @ 3:43 PM

Ignite Modification Date: 2026-02-21 @ 1:12 AM

Study NCT ID: NCT00540592

Status: COMPLETED

Last Update Posted: 2018-06-08

First Post: 2007-10-05

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510903', 'term': 'fluarix'}]}}, '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': 'Serious adverse events were assessed from day 0 to day 20 and day 21 to day 179. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.', 'description': 'For the systematically assessed other (non-serious) adverse events,the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.', 'eventGroups': [{'id': 'EG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.', 'otherNumAtRisk': 204, 'otherNumAffected': 107, 'seriousNumAtRisk': 204, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.', 'otherNumAtRisk': 202, 'otherNumAffected': 129, 'seriousNumAtRisk': 202, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.', 'otherNumAtRisk': 202, 'otherNumAffected': 150, 'seriousNumAtRisk': 202, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.', 'otherNumAtRisk': 202, 'otherNumAffected': 121, 'seriousNumAtRisk': 202, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.', 'otherNumAtRisk': 199, 'otherNumAffected': 138, 'seriousNumAtRisk': 199, 'seriousNumAffected': 9}, {'id': 'EG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.', 'otherNumAtRisk': 198, 'otherNumAffected': 158, 'seriousNumAtRisk': 198, 'seriousNumAffected': 10}, {'id': 'EG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.', 'otherNumAtRisk': 198, 'otherNumAffected': 134, 'seriousNumAtRisk': 198, 'seriousNumAffected': 16}, {'id': 'EG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.', 'otherNumAtRisk': 199, 'otherNumAffected': 155, 'seriousNumAtRisk': 199, 'seriousNumAffected': 19}, {'id': 'EG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.', 'otherNumAtRisk': 200, 'otherNumAffected': 74, 'seriousNumAtRisk': 200, 'seriousNumAffected': 15}, {'id': 'EG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.', 'otherNumAtRisk': 203, 'otherNumAffected': 133, 'seriousNumAtRisk': 203, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 111}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 84}, {'groupId': 'EG004', 'numAtRisk': 198, 'numAffected': 91}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 119}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 93}, {'groupId': 'EG007', 'numAtRisk': 198, 'numAffected': 106}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 32}, {'groupId': 'EG009', 'numAtRisk': 201, 'numAffected': 93}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 198, 'numAffected': 33}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 36}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 18}, {'groupId': 'EG007', 'numAtRisk': 198, 'numAffected': 34}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 198, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 197, 'numAffected': 23}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 198, 'numAffected': 25}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 198, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 45}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 28}, {'groupId': 'EG007', 'numAtRisk': 198, 'numAffected': 35}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 16}, {'groupId': 'EG009', 'numAtRisk': 201, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 198, 'numAffected': 46}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 55}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 38}, {'groupId': 'EG007', 'numAtRisk': 198, 'numAffected': 63}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 24}, {'groupId': 'EG009', 'numAtRisk': 201, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 198, 'numAffected': 39}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 55}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 36}, {'groupId': 'EG007', 'numAtRisk': 198, 'numAffected': 48}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 23}, {'groupId': 'EG009', 'numAtRisk': 201, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 57}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 30}, {'groupId': 'EG004', 'numAtRisk': 198, 'numAffected': 47}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 66}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 46}, {'groupId': 'EG007', 'numAtRisk': 198, 'numAffected': 56}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 19}, {'groupId': 'EG009', 'numAtRisk': 201, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 198, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 18}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 198, 'numAffected': 14}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 201, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shivering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 201, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 198, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 43}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 17}, {'groupId': 'EG007', 'numAtRisk': 198, 'numAffected': 31}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 8}, {'groupId': 'EG009', 'numAtRisk': 201, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bile duct stone', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder cancer', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholelithiasis', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive pulmonary disease', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea exertional', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial bones fracture', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric ulcer haemorrhage', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Goitre', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip fracture', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischaemic stroke', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple myeloma', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal chest pain', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatic neoplasm', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Post procedural infection', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin injury', 'notes': 'Assessed between Day 0 and Day 20', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoarthritis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate cancer', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina pectoris', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral arterial occlusive disease', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina unstable', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematoma', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Left ventricular failure', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper limb fracture', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine cancer', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Wrist fracture', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal adhesions', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrioventricular block first degree', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Benign salivary gland neoplasm', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bifascicular block', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Biliary colic', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding varicose vein', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Carotid artery stenosis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral haemorrhage', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral infarction', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervical vertebral fracture', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis chronic', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholelithiasis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic myeloid leukaemia', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic myelomonocytic leukaemia', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive pulmonary disease', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Clavicle fracture', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colon cancer', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery stenosis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystitis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Emphysema', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erysipelas', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Food poisoning', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gangrene', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric ulcer', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis norovirus', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal haemorrhage', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Glaucoma', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand fracture', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes Zoster', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydronephrosis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive cardiomyopathy', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive crisis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycaemia', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypovolaemic shock', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileus', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incisional hernia', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intervertebral disc protrusion', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Jaw fracture', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Metastases to central nervous system', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple fractures', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal septum deviation', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolithiasis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuritis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoporotic fracture', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Panic attack', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pelvic fracture', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Postmenopausal haemorrhage', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate cancer metastatic', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostatic adenoma', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Reversible ischaemic neurological deficit', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sick sinus syndrome', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Staphylococcal sepsis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope vasovagal', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thyroid neoplasm', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischaemic attack', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ulcerative keratitis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urosepsis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Varicose vein', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vestibular disorder', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vestibular neuronitis', 'notes': 'Assessed between Day 21 and Day 179', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 203, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Haemagglutination Inhibition (HI) Antibody Titers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}, {'value': '192', 'groupId': 'OG004'}, {'value': '193', 'groupId': 'OG005'}, {'value': '192', 'groupId': 'OG006'}, {'value': '189', 'groupId': 'OG007'}, {'value': '188', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'A/Solomon Islands strain', 'categories': [{'measurements': [{'value': '82.3', 'groupId': 'OG000', 'lowerLimit': '69.7', 'upperLimit': '97.1'}, {'value': '102.2', 'groupId': 'OG001', 'lowerLimit': '87.0', 'upperLimit': '119.9'}, {'value': '98.2', 'groupId': 'OG002', 'lowerLimit': '84.3', 'upperLimit': '114.3'}, {'value': '91.7', 'groupId': 'OG003', 'lowerLimit': '76.9', 'upperLimit': '109.3'}, {'value': '113.2', 'groupId': 'OG004', 'lowerLimit': '96.0', 'upperLimit': '133.6'}, {'value': '114.4', 'groupId': 'OG005', 'lowerLimit': '97.1', 'upperLimit': '134.8'}, {'value': '78.5', 'groupId': 'OG006', 'lowerLimit': '65.9', 'upperLimit': '93.5'}, {'value': '111.8', 'groupId': 'OG007', 'lowerLimit': '93.3', 'upperLimit': '134.0'}, {'value': '59.6', 'groupId': 'OG008', 'lowerLimit': '49.6', 'upperLimit': '71.7'}]}]}, {'title': 'A/Wisconsin strain', 'categories': [{'measurements': [{'value': '276.2', 'groupId': 'OG000', 'lowerLimit': '238.8', 'upperLimit': '319.6'}, {'value': '350.2', 'groupId': 'OG001', 'lowerLimit': '298.0', 'upperLimit': '411.4'}, {'value': '351.3', 'groupId': 'OG002', 'lowerLimit': '304.8', 'upperLimit': '404.8'}, {'value': '309.2', 'groupId': 'OG003', 'lowerLimit': '264.9', 'upperLimit': '361.0'}, {'value': '331.1', 'groupId': 'OG004', 'lowerLimit': '289.6', 'upperLimit': '378.6'}, {'value': '438.1', 'groupId': 'OG005', 'lowerLimit': '379.7', 'upperLimit': '505.4'}, {'value': '263.3', 'groupId': 'OG006', 'lowerLimit': '225.3', 'upperLimit': '307.7'}, {'value': '347.5', 'groupId': 'OG007', 'lowerLimit': '296.4', 'upperLimit': '407.3'}, {'value': '186.7', 'groupId': 'OG008', 'lowerLimit': '158.0', 'upperLimit': '220.7'}]}]}, {'title': 'B/Malaysia strain', 'categories': [{'measurements': [{'value': '147.1', 'groupId': 'OG000', 'lowerLimit': '129.1', 'upperLimit': '167.6'}, {'value': '163.1', 'groupId': 'OG001', 'lowerLimit': '142.5', 'upperLimit': '186.6'}, {'value': '172.1', 'groupId': 'OG002', 'lowerLimit': '149.9', 'upperLimit': '197.6'}, {'value': '152.4', 'groupId': 'OG003', 'lowerLimit': '134.4', 'upperLimit': '172.7'}, {'value': '181.4', 'groupId': 'OG004', 'lowerLimit': '158.9', 'upperLimit': '207.1'}, {'value': '202.0', 'groupId': 'OG005', 'lowerLimit': '179.7', 'upperLimit': '227.1'}, {'value': '155.7', 'groupId': 'OG006', 'lowerLimit': '134.8', 'upperLimit': '179.8'}, {'value': '174.6', 'groupId': 'OG007', 'lowerLimit': '152.0', 'upperLimit': '200.7'}, {'value': 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'12.2'}, {'value': '10.8', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '12.4'}, {'value': '10.1', 'groupId': 'OG002', 'lowerLimit': '8.8', 'upperLimit': '11.5'}, {'value': '10.6', 'groupId': 'OG003', 'lowerLimit': '9.3', 'upperLimit': '12.1'}, {'value': '12.0', 'groupId': 'OG004', 'lowerLimit': '10.3', 'upperLimit': '14.0'}, {'value': '9.9', 'groupId': 'OG005', 'lowerLimit': '8.6', 'upperLimit': '11.3'}, {'value': '10.2', 'groupId': 'OG006', 'lowerLimit': '8.9', 'upperLimit': '11.7'}, {'value': '10.3', 'groupId': 'OG007', 'lowerLimit': '9.0', 'upperLimit': '11.9'}, {'value': '10.7', 'groupId': 'OG008', 'lowerLimit': '9.2', 'upperLimit': '12.4'}, {'value': '21.3', 'groupId': 'OG009', 'lowerLimit': '17.1', 'upperLimit': '26.5'}]}]}, {'title': 'A/Solomon Islands strain at Day 21', 'categories': [{'measurements': [{'value': '82.3', 'groupId': 'OG000', 'lowerLimit': '69.7', 'upperLimit': '97.1'}, {'value': '102.2', 'groupId': 'OG001', 'lowerLimit': '87.0', 'upperLimit': '119.9'}, {'value': '98.2', 'groupId': 'OG002', 'lowerLimit': '84.3', 'upperLimit': '114.3'}, {'value': '91.7', 'groupId': 'OG003', 'lowerLimit': '76.9', 'upperLimit': '109.3'}, {'value': '113.2', 'groupId': 'OG004', 'lowerLimit': '96.0', 'upperLimit': '133.6'}, {'value': '114.4', 'groupId': 'OG005', 'lowerLimit': '97.1', 'upperLimit': '134.8'}, {'value': '78.5', 'groupId': 'OG006', 'lowerLimit': '65.9', 'upperLimit': '93.5'}, {'value': '111.8', 'groupId': 'OG007', 'lowerLimit': '93.3', 'upperLimit': '134.0'}, {'value': '59.6', 'groupId': 'OG008', 'lowerLimit': '49.6', 'upperLimit': '71.7'}, {'value': '271.6', 'groupId': 'OG009', 'lowerLimit': '224.6', 'upperLimit': '328.4'}]}]}, {'title': 'A/Wisconsin strain at Day 0', 'categories': [{'measurements': [{'value': '59.9', 'groupId': 'OG000', 'lowerLimit': '49.5', 'upperLimit': '72.4'}, {'value': '51.2', 'groupId': 'OG001', 'lowerLimit': '41.9', 'upperLimit': '62.4'}, {'value': '44.4', 'groupId': 'OG002', 'lowerLimit': '36.5', 'upperLimit': '54.0'}, {'value': '65.7', 'groupId': 'OG003', 'lowerLimit': '53.7', 'upperLimit': '80.4'}, {'value': '61.1', 'groupId': 'OG004', 'lowerLimit': '50.6', 'upperLimit': '73.8'}, {'value': '55.8', 'groupId': 'OG005', 'lowerLimit': '46.2', 'upperLimit': '67.4'}, {'value': '54.6', 'groupId': 'OG006', 'lowerLimit': '44.5', 'upperLimit': '67.0'}, {'value': '57.8', 'groupId': 'OG007', 'lowerLimit': '47.1', 'upperLimit': '70.9'}, {'value': '61.0', 'groupId': 'OG008', 'lowerLimit': '49.8', 'upperLimit': '74.7'}, {'value': '47.8', 'groupId': 'OG009', 'lowerLimit': '39.2', 'upperLimit': '58.4'}]}]}, {'title': 'A/Wisconsin strain at Day 21', 'categories': [{'measurements': [{'value': '276.2', 'groupId': 'OG000', 'lowerLimit': '238.8', 'upperLimit': '319.6'}, {'value': '350.2', 'groupId': 'OG001', 'lowerLimit': '298.0', 'upperLimit': '411.4'}, {'value': '351.3', 'groupId': 'OG002', 'lowerLimit': '304.8', 'upperLimit': '404.8'}, {'value': '309.2', 'groupId': 'OG003', 'lowerLimit': '264.9', 'upperLimit': '361.0'}, {'value': '331.1', 'groupId': 'OG004', 'lowerLimit': '289.6', 'upperLimit': '378.6'}, {'value': '438.1', 'groupId': 'OG005', 'lowerLimit': '379.7', 'upperLimit': '505.4'}, {'value': '263.3', 'groupId': 'OG006', 'lowerLimit': '225.3', 'upperLimit': '307.7'}, {'value': '347.5', 'groupId': 'OG007', 'lowerLimit': '296.4', 'upperLimit': '407.3'}, {'value': '186.7', 'groupId': 'OG008', 'lowerLimit': '158.0', 'upperLimit': '220.7'}, {'value': '380.2', 'groupId': 'OG009', 'lowerLimit': '331.6', 'upperLimit': '435.9'}]}]}, {'title': 'B/Malaysia strain at Day 0', 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000', 'lowerLimit': '49.8', 'upperLimit': '68.9'}, {'value': '53.7', 'groupId': 'OG001', 'lowerLimit': '45.7', 'upperLimit': '63.2'}, {'value': '57.0', 'groupId': 'OG002', 'lowerLimit': '48.2', 'upperLimit': '67.5'}, {'value': '62.6', 'groupId': 'OG003', 'lowerLimit': '53.3', 'upperLimit': '73.4'}, {'value': '77.8', 'groupId': 'OG004', 'lowerLimit': '66.0', 'upperLimit': '91.7'}, {'value': '62.9', 'groupId': 'OG005', 'lowerLimit': '53.9', 'upperLimit': '73.4'}, {'value': '58.2', 'groupId': 'OG006', 'lowerLimit': '49.0', 'upperLimit': '69.1'}, {'value': '62.6', 'groupId': 'OG007', 'lowerLimit': '53.0', 'upperLimit': '74.0'}, {'value': '66.5', 'groupId': 'OG008', 'lowerLimit': '56.5', 'upperLimit': '78.3'}, {'value': '23.4', 'groupId': 'OG009', 'lowerLimit': '19.1', 'upperLimit': '28.7'}]}]}, {'title': 'B/Malaysia strain at Day 21', 'categories': [{'measurements': [{'value': '147.1', 'groupId': 'OG000', 'lowerLimit': '129.1', 'upperLimit': '167.6'}, {'value': '163.1', 'groupId': 'OG001', 'lowerLimit': '142.5', 'upperLimit': '186.6'}, {'value': '172.1', 'groupId': 'OG002', 'lowerLimit': '149.9', 'upperLimit': '197.6'}, {'value': '152.4', 'groupId': 'OG003', 'lowerLimit': '134.4', 'upperLimit': '172.7'}, {'value': '181.4', 'groupId': 'OG004', 'lowerLimit': '158.9', 'upperLimit': '207.1'}, {'value': '202.0', 'groupId': 'OG005', 'lowerLimit': '179.7', 'upperLimit': '227.1'}, {'value': '155.7', 'groupId': 'OG006', 'lowerLimit': '134.8', 'upperLimit': '179.8'}, {'value': '174.6', 'groupId': 'OG007', 'lowerLimit': '152.0', 'upperLimit': '200.7'}, {'value': '153.0', 'groupId': 'OG008', 'lowerLimit': '135.2', 'upperLimit': '173.1'}, {'value': '281.9', 'groupId': 'OG009', 'lowerLimit': '241.7', 'upperLimit': '328.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 0 and 21', 'description': 'Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.'}, {'type': 'SECONDARY', 'title': 'HI Antibody Titers at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '184', 'groupId': 'OG003'}, {'value': '180', 'groupId': 'OG004'}, {'value': '187', 'groupId': 'OG005'}, {'value': '187', 'groupId': 'OG006'}, {'value': '174', 'groupId': 'OG007'}, {'value': '181', 'groupId': 'OG008'}, {'value': '165', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'A/Solomon Islands strain', 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '25.8', 'upperLimit': '36.3'}, {'value': '35.1', 'groupId': 'OG001', 'lowerLimit': '29.7', 'upperLimit': '41.5'}, {'value': '36.3', 'groupId': 'OG002', 'lowerLimit': '30.7', 'upperLimit': '42.8'}, {'value': '32.5', 'groupId': 'OG003', 'lowerLimit': '27.6', 'upperLimit': '38.2'}, {'value': '40.4', 'groupId': 'OG004', 'lowerLimit': '34.1', 'upperLimit': '47.9'}, {'value': '33.7', 'groupId': 'OG005', 'lowerLimit': '28.6', 'upperLimit': '39.7'}, {'value': '29.9', 'groupId': 'OG006', 'lowerLimit': '25.5', 'upperLimit': '35.0'}, {'value': '39.8', 'groupId': 'OG007', 'lowerLimit': '33.6', 'upperLimit': '47.2'}, {'value': '23.7', 'groupId': 'OG008', 'lowerLimit': '20.3', 'upperLimit': '27.7'}, {'value': '114.7', 'groupId': 'OG009', 'lowerLimit': '91.8', 'upperLimit': '143.5'}]}]}, {'title': 'A/Wisconsin strain', 'categories': [{'measurements': [{'value': '131.5', 'groupId': 'OG000', 'lowerLimit': '112.6', 'upperLimit': '153.5'}, {'value': '139.8', 'groupId': 'OG001', 'lowerLimit': '118.1', 'upperLimit': '165.5'}, {'value': '133.4', 'groupId': 'OG002', 'lowerLimit': '112.7', 'upperLimit': '158.1'}, {'value': '134.0', 'groupId': 'OG003', 'lowerLimit': '113.1', 'upperLimit': '158.7'}, {'value': '144.7', 'groupId': 'OG004', 'lowerLimit': '124.9', 'upperLimit': '167.5'}, {'value': '181.4', 'groupId': 'OG005', 'lowerLimit': '156.5', 'upperLimit': '210.3'}, {'value': '118.2', 'groupId': 'OG006', 'lowerLimit': '99.8', 'upperLimit': '140.0'}, {'value': '145.3', 'groupId': 'OG007', 'lowerLimit': '121.9', 'upperLimit': '173.2'}, {'value': '92.5', 'groupId': 'OG008', 'lowerLimit': '78.7', 'upperLimit': '108.6'}, {'value': '193.2', 'groupId': 'OG009', 'lowerLimit': '163.5', 'upperLimit': '228.3'}]}]}, {'title': 'B/Malaysia strain', 'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000', 'lowerLimit': '81.2', 'upperLimit': '106.0'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '81.6', 'upperLimit': '109.1'}, {'value': '100.9', 'groupId': 'OG002', 'lowerLimit': '87.7', 'upperLimit': '116.1'}, {'value': '87.4', 'groupId': 'OG003', 'lowerLimit': '75.9', 'upperLimit': '100.6'}, {'value': '109.2', 'groupId': 'OG004', 'lowerLimit': '94.9', 'upperLimit': '125.6'}, {'value': '111.4', 'groupId': 'OG005', 'lowerLimit': '97.2', 'upperLimit': '127.6'}, {'value': '89.0', 'groupId': 'OG006', 'lowerLimit': '76.1', 'upperLimit': '104.0'}, {'value': '97.7', 'groupId': 'OG007', 'lowerLimit': '84.7', 'upperLimit': '112.7'}, {'value': '96.6', 'groupId': 'OG008', 'lowerLimit': '83.8', 'upperLimit': '111.3'}, {'value': '132.4', 'groupId': 'OG009', 'lowerLimit': '110.2', 'upperLimit': '159.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 180', 'description': 'Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.'}, {'type': 'SECONDARY', 'title': 'The Number of Subjects Seroconverted to HI Antibodies at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}, {'value': '192', 'groupId': 'OG004'}, {'value': '193', 'groupId': 'OG005'}, {'value': '192', 'groupId': 'OG006'}, {'value': '189', 'groupId': 'OG007'}, {'value': '187', 'groupId': 'OG008'}, {'value': '197', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'A/Solomon Islands strain', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}, {'value': '130', 'groupId': 'OG003'}, {'value': '142', 'groupId': 'OG004'}, {'value': '151', 'groupId': 'OG005'}, {'value': '129', 'groupId': 'OG006'}, {'value': '146', 'groupId': 'OG007'}, {'value': '99', 'groupId': 'OG008'}, {'value': '135', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin strain', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '124', 'groupId': 'OG004'}, {'value': '142', 'groupId': 'OG005'}, {'value': '110', 'groupId': 'OG006'}, {'value': '131', 'groupId': 'OG007'}, {'value': '69', 'groupId': 'OG008'}, {'value': '130', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia strain', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}, {'value': '55', 'groupId': 'OG007'}, {'value': '47', 'groupId': 'OG008'}, {'value': '147', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 21', 'description': 'A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.'}, {'type': 'SECONDARY', 'title': 'The Number of Subjects Seroconverted to HI Antibodies at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '184', 'groupId': 'OG003'}, {'value': '180', 'groupId': 'OG004'}, {'value': '187', 'groupId': 'OG005'}, {'value': '187', 'groupId': 'OG006'}, {'value': '174', 'groupId': 'OG007'}, {'value': '180', 'groupId': 'OG008'}, {'value': '165', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'A/Solomon Islands strain', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '60', 'groupId': 'OG004'}, {'value': '77', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '67', 'groupId': 'OG007'}, {'value': '42', 'groupId': 'OG008'}, {'value': '90', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin strain', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '74', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}, {'value': '49', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '74', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia strain', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '90', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 180', 'description': 'A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.'}, {'type': 'SECONDARY', 'title': 'HI Antibody Seroconversion Factors at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}, {'value': '192', 'groupId': 'OG004'}, {'value': '193', 'groupId': 'OG005'}, {'value': '192', 'groupId': 'OG006'}, {'value': '189', 'groupId': 'OG007'}, {'value': '187', 'groupId': 'OG008'}, {'value': '197', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'A/Solomon Islands strain', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '9.2'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '11.3'}, {'value': '9.8', 'groupId': 'OG002', 'lowerLimit': '8.3', 'upperLimit': '11.5'}, {'value': '8.6', 'groupId': 'OG003', 'lowerLimit': '7.2', 'upperLimit': '10.4'}, {'value': '9.4', 'groupId': 'OG004', 'lowerLimit': '8.0', 'upperLimit': '11.1'}, {'value': '11.6', 'groupId': 'OG005', 'lowerLimit': '9.7', 'upperLimit': '13.9'}, {'value': '7.7', 'groupId': 'OG006', 'lowerLimit': '6.5', 'upperLimit': '9.2'}, {'value': '10.8', 'groupId': 'OG007', 'lowerLimit': '9.0', 'upperLimit': '13.0'}, {'value': '5.6', 'groupId': 'OG008', 'lowerLimit': '4.7', 'upperLimit': '6.8'}, {'value': '12.8', 'groupId': 'OG009', 'lowerLimit': '10.0', 'upperLimit': '16.3'}]}]}, {'title': 'A/Wisconsin strain', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '5.4'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '8.1'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '6.6', 'upperLimit': '9.5'}, {'value': '4.7', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '5.5'}, {'value': '5.4', 'groupId': 'OG004', 'lowerLimit': '4.6', 'upperLimit': '6.3'}, {'value': '7.8', 'groupId': 'OG005', 'lowerLimit': '6.5', 'upperLimit': '9.5'}, {'value': '4.8', 'groupId': 'OG006', 'lowerLimit': '4.1', 'upperLimit': '5.7'}, {'value': '6.0', 'groupId': 'OG007', 'lowerLimit': '5.1', 'upperLimit': '7.1'}, {'value': '3.1', 'groupId': 'OG008', 'lowerLimit': '2.6', 'upperLimit': '3.6'}, {'value': '7.9', 'groupId': 'OG009', 'lowerLimit': '6.4', 'upperLimit': '9.8'}]}]}, {'title': 'B/Malaysia strain', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '2.8'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '3.5'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '2.6', 'upperLimit': '3.5'}, {'value': '2.4', 'groupId': 'OG003', 'lowerLimit': '2.2', 'upperLimit': '2.8'}, {'value': '2.3', 'groupId': 'OG004', 'lowerLimit': '2.1', 'upperLimit': '2.6'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '2.8', 'upperLimit': '3.7'}, {'value': '2.7', 'groupId': 'OG006', 'lowerLimit': '2.3', 'upperLimit': '3.1'}, {'value': '2.8', 'groupId': 'OG007', 'lowerLimit': '2.4', 'upperLimit': '3.2'}, {'value': '2.3', 'groupId': 'OG008', 'lowerLimit': '2.0', 'upperLimit': '2.6'}, {'value': '12.0', 'groupId': 'OG009', 'lowerLimit': '9.7', 'upperLimit': '15.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 21', 'description': 'Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.', 'unitOfMeasure': 'fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.'}, {'type': 'SECONDARY', 'title': 'HI Antibody Seroconversion Factors at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '184', 'groupId': 'OG003'}, {'value': '180', 'groupId': 'OG004'}, {'value': '187', 'groupId': 'OG005'}, {'value': '187', 'groupId': 'OG006'}, {'value': '174', 'groupId': 'OG007'}, {'value': '180', 'groupId': 'OG008'}, {'value': '165', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'A/Solomon Islands strain', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '3.4'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '3.9'}, {'value': '3.5', 'groupId': 'OG002', 'lowerLimit': '3.1', 'upperLimit': '4.1'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '2.6', 'upperLimit': '3.5'}, {'value': '3.3', 'groupId': 'OG004', 'lowerLimit': '2.9', 'upperLimit': '3.8'}, {'value': '3.5', 'groupId': 'OG005', 'lowerLimit': '2.9', 'upperLimit': '4.1'}, {'value': '2.9', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '3.3'}, {'value': '3.8', 'groupId': 'OG007', 'lowerLimit': '3.2', 'upperLimit': '4.4'}, {'value': '2.2', 'groupId': 'OG008', 'lowerLimit': '1.9', 'upperLimit': '2.6'}, {'value': '5.7', 'groupId': 'OG009', 'lowerLimit': '4.5', 'upperLimit': '7.2'}]}]}, {'title': 'A/Wisconsin strain', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '2.6'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '3.1'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '3.3'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '1.8', 'upperLimit': '2.3'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '2.1', 'upperLimit': '2.7'}, {'value': '3.1', 'groupId': 'OG005', 'lowerLimit': '2.7', 'upperLimit': '3.6'}, {'value': '2.1', 'groupId': 'OG006', 'lowerLimit': '1.8', 'upperLimit': '2.4'}, {'value': '2.5', 'groupId': 'OG007', 'lowerLimit': '2.2', 'upperLimit': '2.9'}, {'value': '1.6', 'groupId': 'OG008', 'lowerLimit': '1.4', 'upperLimit': '1.8'}, {'value': '4.0', 'groupId': 'OG009', 'lowerLimit': '3.2', 'upperLimit': '5.0'}]}]}, {'title': 'B/Malaysia strain', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '1.9'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '1.9'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '1.9'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '1.6'}, {'value': '1.4', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '1.6'}, {'value': '1.8', 'groupId': 'OG005', 'lowerLimit': '1.6', 'upperLimit': '2.0'}, {'value': '1.5', 'groupId': 'OG006', 'lowerLimit': '1.4', 'upperLimit': '1.7'}, {'value': '1.6', 'groupId': 'OG007', 'lowerLimit': '1.4', 'upperLimit': '1.8'}, {'value': '1.5', 'groupId': 'OG008', 'lowerLimit': '1.3', 'upperLimit': '1.7'}, {'value': '5.6', 'groupId': 'OG009', 'lowerLimit': '4.5', 'upperLimit': '7.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 180', 'description': 'Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.', 'unitOfMeasure': 'fold increase', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.'}, {'type': 'SECONDARY', 'title': 'The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}, {'value': '194', 'groupId': 'OG003'}, {'value': '192', 'groupId': 'OG004'}, {'value': '193', 'groupId': 'OG005'}, {'value': '192', 'groupId': 'OG006'}, {'value': '189', 'groupId': 'OG007'}, {'value': '188', 'groupId': 'OG008'}, {'value': '197', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'A/Solomon Islands strain at Day 0', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}, {'value': '69', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands strain at Day 21', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}, {'value': '158', 'groupId': 'OG003'}, {'value': '169', 'groupId': 'OG004'}, {'value': '172', 'groupId': 'OG005'}, {'value': '153', 'groupId': 'OG006'}, {'value': '163', 'groupId': 'OG007'}, {'value': '132', 'groupId': 'OG008'}, {'value': '182', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin strain at Day 0', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '131', 'groupId': 'OG004'}, {'value': '139', 'groupId': 'OG005'}, {'value': '130', 'groupId': 'OG006'}, {'value': '134', 'groupId': 'OG007'}, {'value': '132', 'groupId': 'OG008'}, {'value': '122', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin strain at Day 21', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}, {'value': '190', 'groupId': 'OG003'}, {'value': '192', 'groupId': 'OG004'}, {'value': '191', 'groupId': 'OG005'}, {'value': '187', 'groupId': 'OG006'}, {'value': '185', 'groupId': 'OG007'}, {'value': '179', 'groupId': 'OG008'}, {'value': '197', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia strain at Day 0', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '148', 'groupId': 'OG003'}, {'value': '156', 'groupId': 'OG004'}, {'value': '149', 'groupId': 'OG005'}, {'value': '139', 'groupId': 'OG006'}, {'value': '145', 'groupId': 'OG007'}, {'value': '144', 'groupId': 'OG008'}, {'value': '77', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia strain at Day 21', 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '187', 'groupId': 'OG003'}, {'value': '186', 'groupId': 'OG004'}, {'value': '192', 'groupId': 'OG005'}, {'value': '182', 'groupId': 'OG006'}, {'value': '184', 'groupId': 'OG007'}, {'value': '183', 'groupId': 'OG008'}, {'value': '195', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 0 and 21', 'description': 'A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 21.'}, {'type': 'SECONDARY', 'title': 'The Number of Subjects Seroprotected to HI Antibodies at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '184', 'groupId': 'OG003'}, {'value': '180', 'groupId': 'OG004'}, {'value': '187', 'groupId': 'OG005'}, {'value': '187', 'groupId': 'OG006'}, {'value': '174', 'groupId': 'OG007'}, {'value': '181', 'groupId': 'OG008'}, {'value': '165', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'A/Solomon Islands strain', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}, {'value': '103', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}, {'value': '100', 'groupId': 'OG006'}, {'value': '100', 'groupId': 'OG007'}, {'value': '77', 'groupId': 'OG008'}, {'value': '135', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin strain', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}, {'value': '164', 'groupId': 'OG003'}, {'value': '170', 'groupId': 'OG004'}, {'value': '179', 'groupId': 'OG005'}, {'value': '166', 'groupId': 'OG006'}, {'value': '160', 'groupId': 'OG007'}, {'value': '156', 'groupId': 'OG008'}, {'value': '158', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia strain', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '166', 'groupId': 'OG004'}, {'value': '176', 'groupId': 'OG005'}, {'value': '158', 'groupId': 'OG006'}, {'value': '162', 'groupId': 'OG007'}, {'value': '162', 'groupId': 'OG008'}, {'value': '144', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 180', 'description': 'A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on According-to-Protocol (ATP) cohort for persistence for HI which included all evaluable subjects for whom data concerning immunogenicity HI outcome measures were available at day 180.'}, {'type': 'SECONDARY', 'title': 'The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '23', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'A/Solomon Islands [CD4-All doubles] at Day 0', 'categories': [{'measurements': [{'value': '177.48', 'spread': '278.18', 'groupId': 'OG000'}, {'value': '283.18', 'spread': '319.74', 'groupId': 'OG001'}, {'value': '204.49', 'spread': '236.05', 'groupId': 'OG002'}, {'value': '200.21', 'spread': '480.41', 'groupId': 'OG003'}, {'value': '193.35', 'spread': '324.34', 'groupId': 'OG004'}, {'value': '177.44', 'spread': '297.52', 'groupId': 'OG005'}, {'value': '199.80', 'spread': '310.58', 'groupId': 'OG006'}, {'value': '222.58', 'spread': '282.91', 'groupId': 'OG007'}, {'value': '156.21', 'spread': '518.89', 'groupId': 'OG008'}, {'value': '538.72', 'spread': '442.78', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD4-All doubles] at Day 21', 'categories': [{'measurements': [{'value': '441.16', 'spread': '517.73', 'groupId': 'OG000'}, {'value': '856.00', 'spread': '685.35', 'groupId': 'OG001'}, {'value': '704.14', 'spread': '778.07', 'groupId': 'OG002'}, {'value': '494.63', 'spread': '883.53', 'groupId': 'OG003'}, {'value': '483.24', 'spread': '481.37', 'groupId': 'OG004'}, {'value': '808.90', 'spread': '858.38', 'groupId': 'OG005'}, {'value': '655.32', 'spread': '616.75', 'groupId': 'OG006'}, {'value': '797.68', 'spread': '5271.86', 'groupId': 'OG007'}, {'value': '536.24', 'spread': '578.48', 'groupId': 'OG008'}, {'value': '1027.23', 'spread': '838.01', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-All doubles] at Day 0', 'categories': [{'measurements': [{'value': '583.77', 'spread': '563.98', 'groupId': 'OG000'}, {'value': '488.70', 'spread': '540.66', 'groupId': 'OG001'}, {'value': '584.25', 'spread': '626.26', 'groupId': 'OG002'}, {'value': '309.67', 'spread': '517.11', 'groupId': 'OG003'}, {'value': '538.87', 'spread': '691.59', 'groupId': 'OG004'}, {'value': '702.79', 'spread': '3741.48', 'groupId': 'OG005'}, {'value': '457.98', 'spread': '321.69', 'groupId': 'OG006'}, {'value': '594.26', 'spread': '598.83', 'groupId': 'OG007'}, {'value': '427.71', 'spread': '745.78', 'groupId': 'OG008'}, {'value': '821.78', 'spread': '646.48', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-All doubles] at Day 21', 'categories': [{'measurements': [{'value': '1016.63', 'spread': '990.97', 'groupId': 'OG000'}, {'value': '1491.86', 'spread': '899.50', 'groupId': 'OG001'}, {'value': '1140.56', 'spread': '955.61', 'groupId': 'OG002'}, {'value': '1015.18', 'spread': '1044.87', 'groupId': 'OG003'}, {'value': '1051.06', 'spread': '1024.97', 'groupId': 'OG004'}, {'value': '1998.33', 'spread': '2730.32', 'groupId': 'OG005'}, {'value': '1234.37', 'spread': '830.47', 'groupId': 'OG006'}, {'value': '1302.34', 'spread': '3490.03', 'groupId': 'OG007'}, {'value': '922.62', 'spread': '1170.30', 'groupId': 'OG008'}, {'value': '1455.68', 'spread': '870.69', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-All doubles] at Day 0', 'categories': [{'measurements': [{'value': '407.18', 'spread': '456.82', 'groupId': 'OG000'}, {'value': '596.53', 'spread': '400.24', 'groupId': 'OG001'}, {'value': '500.81', 'spread': '734.64', 'groupId': 'OG002'}, {'value': '250.48', 'spread': '375.23', 'groupId': 'OG003'}, {'value': '490.56', 'spread': '546.12', 'groupId': 'OG004'}, {'value': '259.15', 'spread': '278.35', 'groupId': 'OG005'}, {'value': '403.06', 'spread': '482.16', 'groupId': 'OG006'}, {'value': '442.39', 'spread': '315.27', 'groupId': 'OG007'}, {'value': '301.23', 'spread': '584.68', 'groupId': 'OG008'}, {'value': '1098.75', 'spread': '909.18', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-All doubles] at Day 21', 'categories': [{'measurements': [{'value': '1025.01', 'spread': '736.55', 'groupId': 'OG000'}, {'value': '1614.14', 'spread': '953.74', 'groupId': 'OG001'}, {'value': '1005.72', 'spread': '1314.69', 'groupId': 'OG002'}, {'value': '817.57', 'spread': '675.70', 'groupId': 'OG003'}, {'value': '1019.48', 'spread': '698.91', 'groupId': 'OG004'}, {'value': '1255.53', 'spread': '941.27', 'groupId': 'OG005'}, {'value': '1153.76', 'spread': '699.26', 'groupId': 'OG006'}, {'value': '1057.60', 'spread': '4968.52', 'groupId': 'OG007'}, {'value': '781.66', 'spread': '880.46', 'groupId': 'OG008'}, {'value': '1707.62', 'spread': '1591.31', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD4-CD40L] at Day 0', 'categories': [{'measurements': [{'value': '187.19', 'spread': '277.14', 'groupId': 'OG000'}, {'value': '285.19', 'spread': '319.80', 'groupId': 'OG001'}, {'value': '193.56', 'spread': '236.01', 'groupId': 'OG002'}, {'value': '141.26', 'spread': '500.24', 'groupId': 'OG003'}, {'value': '192.02', 'spread': '314.38', 'groupId': 'OG004'}, {'value': '167.87', 'spread': '296.47', 'groupId': 'OG005'}, {'value': '153.91', 'spread': '311.96', 'groupId': 'OG006'}, {'value': '165.48', 'spread': '281.57', 'groupId': 'OG007'}, {'value': '150.60', 'spread': '512.37', 'groupId': 'OG008'}, {'value': '504.55', 'spread': '441.35', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD4-CD40L] at Day 21', 'categories': [{'measurements': [{'value': '418.24', 'spread': '523.39', 'groupId': 'OG000'}, {'value': '657.41', 'spread': '684.48', 'groupId': 'OG001'}, {'value': '641.98', 'spread': '752.95', 'groupId': 'OG002'}, {'value': '471.56', 'spread': '881.73', 'groupId': 'OG003'}, {'value': '391.29', 'spread': '474.16', 'groupId': 'OG004'}, {'value': '510.16', 'spread': '871.38', 'groupId': 'OG005'}, {'value': '599.32', 'spread': '592.08', 'groupId': 'OG006'}, {'value': '697.39', 'spread': '5282.26', 'groupId': 'OG007'}, {'value': '406.14', 'spread': '571.70', 'groupId': 'OG008'}, {'value': '967.83', 'spread': '848.55', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-CD40L] at Day 0', 'categories': [{'measurements': [{'value': '555.20', 'spread': '555.43', 'groupId': 'OG000'}, {'value': '477.12', 'spread': '531.36', 'groupId': 'OG001'}, {'value': '527.80', 'spread': '613.23', 'groupId': 'OG002'}, {'value': '284.63', 'spread': '522.58', 'groupId': 'OG003'}, {'value': '511.21', 'spread': '679.89', 'groupId': 'OG004'}, {'value': '587.17', 'spread': '1872.24', 'groupId': 'OG005'}, {'value': '418.98', 'spread': '333.83', 'groupId': 'OG006'}, {'value': '568.96', 'spread': '559.46', 'groupId': 'OG007'}, {'value': '322.37', 'spread': '713.98', 'groupId': 'OG008'}, {'value': '742.80', 'spread': '659.21', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-CD40L] at Day 21', 'categories': [{'measurements': [{'value': '941.04', 'spread': '994.45', 'groupId': 'OG000'}, {'value': '1438.93', 'spread': '881.80', 'groupId': 'OG001'}, {'value': '1014.97', 'spread': '933.09', 'groupId': 'OG002'}, {'value': '940.53', 'spread': '1065.84', 'groupId': 'OG003'}, {'value': '977.44', 'spread': '970.75', 'groupId': 'OG004'}, {'value': '1763.75', 'spread': '1858.49', 'groupId': 'OG005'}, {'value': '1162.09', 'spread': '715.63', 'groupId': 'OG006'}, {'value': '1156.07', 'spread': '3501.25', 'groupId': 'OG007'}, {'value': '798.75', 'spread': '1155.23', 'groupId': 'OG008'}, {'value': '1383.25', 'spread': '871.98', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-CD40L] at Day 0', 'categories': [{'measurements': [{'value': '387.03', 'spread': '429.86', 'groupId': 'OG000'}, {'value': '587.72', 'spread': '396.47', 'groupId': 'OG001'}, {'value': '446.80', 'spread': '736.88', 'groupId': 'OG002'}, {'value': '219.83', 'spread': '386.13', 'groupId': 'OG003'}, {'value': '479.21', 'spread': '550.01', 'groupId': 'OG004'}, {'value': '256.73', 'spread': '280.28', 'groupId': 'OG005'}, {'value': '383.93', 'spread': '466.87', 'groupId': 'OG006'}, {'value': '431.32', 'spread': '319.06', 'groupId': 'OG007'}, {'value': '342.65', 'spread': '589.08', 'groupId': 'OG008'}, {'value': '1076.46', 'spread': '903.85', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-CD40L] at Day 21', 'categories': [{'measurements': [{'value': '926.13', 'spread': '749.19', 'groupId': 'OG000'}, {'value': '1570.30', 'spread': '962.36', 'groupId': 'OG001'}, {'value': '958.63', 'spread': '1315.41', 'groupId': 'OG002'}, {'value': '754.45', 'spread': '694.91', 'groupId': 'OG003'}, {'value': '975.92', 'spread': '710.25', 'groupId': 'OG004'}, {'value': '1160.31', 'spread': '959.34', 'groupId': 'OG005'}, {'value': '1039.13', 'spread': '699.33', 'groupId': 'OG006'}, {'value': '957.22', 'spread': '5023.06', 'groupId': 'OG007'}, {'value': '707.72', 'spread': '874.64', 'groupId': 'OG008'}, {'value': '1614.08', 'spread': '1617.78', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD4-IFNγ] at Day 0', 'categories': [{'measurements': [{'value': '202.65', 'spread': '195.65', 'groupId': 'OG000'}, {'value': '190.19', 'spread': '245.89', 'groupId': 'OG001'}, {'value': '158.04', 'spread': '192.23', 'groupId': 'OG002'}, {'value': '235.01', 'spread': '355.44', 'groupId': 'OG003'}, {'value': '171.07', 'spread': '194.84', 'groupId': 'OG004'}, {'value': '137.02', 'spread': '189.76', 'groupId': 'OG005'}, {'value': '203.95', 'spread': '254.48', 'groupId': 'OG006'}, {'value': '184.52', 'spread': '211.26', 'groupId': 'OG007'}, {'value': '198.86', 'spread': '422.78', 'groupId': 'OG008'}, {'value': '380.34', 'spread': '384.07', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD4-IFNγ] at Day 21', 'categories': [{'measurements': [{'value': '398.57', 'spread': '370.41', 'groupId': 'OG000'}, {'value': '636.42', 'spread': '570.57', 'groupId': 'OG001'}, {'value': '532.84', 'spread': '488.63', 'groupId': 'OG002'}, {'value': '426.15', 'spread': '660.07', 'groupId': 'OG003'}, {'value': '379.49', 'spread': '361.80', 'groupId': 'OG004'}, {'value': '543.09', 'spread': '681.65', 'groupId': 'OG005'}, {'value': '467.66', 'spread': '450.93', 'groupId': 'OG006'}, {'value': '576.14', 'spread': '4664.15', 'groupId': 'OG007'}, {'value': '442.66', 'spread': '449.36', 'groupId': 'OG008'}, {'value': '755.12', 'spread': '645.89', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-IFNγ] at Day 0', 'categories': [{'measurements': [{'value': '361.99', 'spread': '378.72', 'groupId': 'OG000'}, {'value': '350.04', 'spread': '325.28', 'groupId': 'OG001'}, {'value': '332.39', 'spread': '326.71', 'groupId': 'OG002'}, {'value': '295.56', 'spread': '424.20', 'groupId': 'OG003'}, {'value': '243.93', 'spread': '321.57', 'groupId': 'OG004'}, {'value': '495.18', 'spread': '3550.69', 'groupId': 'OG005'}, {'value': '305.13', 'spread': '248.40', 'groupId': 'OG006'}, {'value': '310.45', 'spread': '276.10', 'groupId': 'OG007'}, {'value': '272.34', 'spread': '453.35', 'groupId': 'OG008'}, {'value': '589.57', 'spread': '493.89', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-IFNγ] at Day 21', 'categories': [{'measurements': [{'value': '644.07', 'spread': '707.63', 'groupId': 'OG000'}, {'value': '891.98', 'spread': '719.87', 'groupId': 'OG001'}, {'value': '809.46', 'spread': '590.21', 'groupId': 'OG002'}, {'value': '606.43', 'spread': '745.80', 'groupId': 'OG003'}, {'value': '651.21', 'spread': '651.51', 'groupId': 'OG004'}, {'value': '1293.10', 'spread': '2390.91', 'groupId': 'OG005'}, {'value': '718.87', 'spread': '619.16', 'groupId': 'OG006'}, {'value': '691.57', 'spread': '2944.57', 'groupId': 'OG007'}, {'value': '548.91', 'spread': '732.46', 'groupId': 'OG008'}, {'value': '976.96', 'spread': '643.43', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-IFNγ] at Day 0', 'categories': [{'measurements': [{'value': '336.70', 'spread': '352.20', 'groupId': 'OG000'}, {'value': '403.08', 'spread': '319.99', 'groupId': 'OG001'}, {'value': '322.07', 'spread': '631.98', 'groupId': 'OG002'}, {'value': '302.23', 'spread': '249.59', 'groupId': 'OG003'}, {'value': '248.66', 'spread': '236.24', 'groupId': 'OG004'}, {'value': '237.57', 'spread': '200.43', 'groupId': 'OG005'}, {'value': '277.94', 'spread': '372.05', 'groupId': 'OG006'}, {'value': '210.23', 'spread': '266.19', 'groupId': 'OG007'}, {'value': '256.03', 'spread': '440.55', 'groupId': 'OG008'}, {'value': '874.82', 'spread': '729.66', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-IFNγ] at Day 21', 'categories': [{'measurements': [{'value': '716.86', 'spread': '601.16', 'groupId': 'OG000'}, {'value': '1163.80', 'spread': '865.47', 'groupId': 'OG001'}, {'value': '855.95', 'spread': '1073.89', 'groupId': 'OG002'}, {'value': '509.84', 'spread': '520.06', 'groupId': 'OG003'}, {'value': '611.65', 'spread': '527.80', 'groupId': 'OG004'}, {'value': '852.80', 'spread': '715.28', 'groupId': 'OG005'}, {'value': '745.46', 'spread': '575.21', 'groupId': 'OG006'}, {'value': '709.84', 'spread': '4385.83', 'groupId': 'OG007'}, {'value': '523.15', 'spread': '697.47', 'groupId': 'OG008'}, {'value': '1306.18', 'spread': '1346.37', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD4-IL2] at Day 0', 'categories': [{'measurements': [{'value': '181.54', 'spread': '242.60', 'groupId': 'OG000'}, {'value': '193.42', 'spread': '297.22', 'groupId': 'OG001'}, {'value': '188.29', 'spread': '215.39', 'groupId': 'OG002'}, {'value': '150.59', 'spread': '407.63', 'groupId': 'OG003'}, {'value': '152.22', 'spread': '284.11', 'groupId': 'OG004'}, {'value': '157.54', 'spread': '255.06', 'groupId': 'OG005'}, {'value': '161.81', 'spread': '293.16', 'groupId': 'OG006'}, {'value': '170.79', 'spread': '253.02', 'groupId': 'OG007'}, {'value': '122.12', 'spread': '451.59', 'groupId': 'OG008'}, {'value': '356.84', 'spread': '313.43', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD4-IL2] at Day 21', 'categories': [{'measurements': [{'value': '299.14', 'spread': '421.84', 'groupId': 'OG000'}, {'value': '664.46', 'spread': '582.79', 'groupId': 'OG001'}, {'value': '559.98', 'spread': '642.32', 'groupId': 'OG002'}, {'value': '415.13', 'spread': '691.39', 'groupId': 'OG003'}, {'value': '409.73', 'spread': '365.35', 'groupId': 'OG004'}, {'value': '677.81', 'spread': '689.59', 'groupId': 'OG005'}, {'value': '529.19', 'spread': '520.65', 'groupId': 'OG006'}, {'value': '678.22', 'spread': '4760.15', 'groupId': 'OG007'}, {'value': '461.05', 'spread': '498.00', 'groupId': 'OG008'}, {'value': '813.73', 'spread': '693.31', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-IL2] at Day 0', 'categories': [{'measurements': [{'value': '406.48', 'spread': '508.99', 'groupId': 'OG000'}, {'value': '382.61', 'spread': '428.51', 'groupId': 'OG001'}, {'value': '516.80', 'spread': '421.85', 'groupId': 'OG002'}, {'value': '251.35', 'spread': '445.04', 'groupId': 'OG003'}, {'value': '388.89', 'spread': '560.47', 'groupId': 'OG004'}, {'value': '532.86', 'spread': '708.29', 'groupId': 'OG005'}, {'value': '393.79', 'spread': '295.93', 'groupId': 'OG006'}, {'value': '470.64', 'spread': '443.13', 'groupId': 'OG007'}, {'value': '343.41', 'spread': '607.93', 'groupId': 'OG008'}, {'value': '589.89', 'spread': '469.14', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-IL2] at Day 21', 'categories': [{'measurements': [{'value': '747.93', 'spread': '778.49', 'groupId': 'OG000'}, {'value': '1082.78', 'spread': '712.53', 'groupId': 'OG001'}, {'value': '1010.24', 'spread': '772.39', 'groupId': 'OG002'}, {'value': '762.07', 'spread': '766.05', 'groupId': 'OG003'}, {'value': '792.75', 'spread': '828.41', 'groupId': 'OG004'}, {'value': '1425.03', 'spread': '1236.35', 'groupId': 'OG005'}, {'value': '908.72', 'spread': '680.48', 'groupId': 'OG006'}, {'value': '1041.76', 'spread': '2883.12', 'groupId': 'OG007'}, {'value': '733.36', 'spread': '900.95', 'groupId': 'OG008'}, {'value': '1061.62', 'spread': '635.42', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-IL2] at Day 0', 'categories': [{'measurements': [{'value': '277.98', 'spread': '394.46', 'groupId': 'OG000'}, {'value': '491.65', 'spread': '369.85', 'groupId': 'OG001'}, {'value': '434.78', 'spread': '621.10', 'groupId': 'OG002'}, {'value': '190.27', 'spread': '322.46', 'groupId': 'OG003'}, {'value': '411.11', 'spread': '457.99', 'groupId': 'OG004'}, {'value': '269.03', 'spread': '243.51', 'groupId': 'OG005'}, {'value': '360.78', 'spread': '420.71', 'groupId': 'OG006'}, {'value': '333.95', 'spread': '309.81', 'groupId': 'OG007'}, {'value': '221.19', 'spread': '537.35', 'groupId': 'OG008'}, {'value': '871.60', 'spread': '724.64', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-IL2] at Day 21', 'categories': [{'measurements': [{'value': '791.31', 'spread': '616.06', 'groupId': 'OG000'}, {'value': '1295.22', 'spread': '856.91', 'groupId': 'OG001'}, {'value': '992.50', 'spread': '1134.21', 'groupId': 'OG002'}, {'value': '692.82', 'spread': '570.55', 'groupId': 'OG003'}, {'value': '876.95', 'spread': '569.97', 'groupId': 'OG004'}, {'value': '1038.01', 'spread': '765.73', 'groupId': 'OG005'}, {'value': '949.33', 'spread': '588.11', 'groupId': 'OG006'}, {'value': '872.00', 'spread': '4655.93', 'groupId': 'OG007'}, {'value': '695.83', 'spread': '757.57', 'groupId': 'OG008'}, {'value': '1348.21', 'spread': '1359.92', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD4-TNFα] at Day 0', 'categories': [{'measurements': [{'value': '91.32', 'spread': '201.60', 'groupId': 'OG000'}, {'value': '155.22', 'spread': '184.44', 'groupId': 'OG001'}, {'value': '130.19', 'spread': '152.33', 'groupId': 'OG002'}, {'value': '124.70', 'spread': '306.20', 'groupId': 'OG003'}, {'value': '143.44', 'spread': '199.20', 'groupId': 'OG004'}, {'value': '112.41', 'spread': '169.39', 'groupId': 'OG005'}, {'value': '100.38', 'spread': '185.42', 'groupId': 'OG006'}, {'value': '111.07', 'spread': '179.39', 'groupId': 'OG007'}, {'value': '104.10', 'spread': '311.25', 'groupId': 'OG008'}, {'value': '234.98', 'spread': '234.23', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD4-TNFα] at Day 21', 'categories': [{'measurements': [{'value': '234.99', 'spread': '298.31', 'groupId': 'OG000'}, {'value': '440.26', 'spread': '451.77', 'groupId': 'OG001'}, {'value': '333.95', 'spread': '487.76', 'groupId': 'OG002'}, {'value': '279.64', 'spread': '553.81', 'groupId': 'OG003'}, {'value': '296.79', 'spread': '289.33', 'groupId': 'OG004'}, {'value': '336.45', 'spread': '541.95', 'groupId': 'OG005'}, {'value': '325.65', 'spread': '410.44', 'groupId': 'OG006'}, {'value': '449.86', 'spread': '3979.03', 'groupId': 'OG007'}, {'value': '273.66', 'spread': '355.95', 'groupId': 'OG008'}, {'value': '490.23', 'spread': '532.90', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-TNFα] at Day 0', 'categories': [{'measurements': [{'value': '351.26', 'spread': '450.82', 'groupId': 'OG000'}, {'value': '458.02', 'spread': '373.43', 'groupId': 'OG001'}, {'value': '432.24', 'spread': '487.63', 'groupId': 'OG002'}, {'value': '342.30', 'spread': '455.39', 'groupId': 'OG003'}, {'value': '404.64', 'spread': '410.30', 'groupId': 'OG004'}, {'value': '600.83', 'spread': '3581.08', 'groupId': 'OG005'}, {'value': '303.13', 'spread': '263.25', 'groupId': 'OG006'}, {'value': '420.75', 'spread': '422.38', 'groupId': 'OG007'}, {'value': '327.09', 'spread': '552.26', 'groupId': 'OG008'}, {'value': '667.60', 'spread': '450.65', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-TNFα] at Day 21', 'categories': [{'measurements': [{'value': '712.96', 'spread': '700.26', 'groupId': 'OG000'}, {'value': '944.29', 'spread': '589.91', 'groupId': 'OG001'}, {'value': '852.44', 'spread': '637.30', 'groupId': 'OG002'}, {'value': '623.21', 'spread': '728.42', 'groupId': 'OG003'}, {'value': '702.41', 'spread': '635.67', 'groupId': 'OG004'}, {'value': '1293.59', 'spread': '2431.45', 'groupId': 'OG005'}, {'value': '802.15', 'spread': '591.12', 'groupId': 'OG006'}, {'value': '884.71', 'spread': '2654.95', 'groupId': 'OG007'}, {'value': '575.97', 'spread': '723.76', 'groupId': 'OG008'}, {'value': '995.86', 'spread': '630.33', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-TNFα] at Day 0', 'categories': [{'measurements': [{'value': '203.89', 'spread': '281.14', 'groupId': 'OG000'}, {'value': '239.73', 'spread': '260.28', 'groupId': 'OG001'}, {'value': '225.66', 'spread': '501.91', 'groupId': 'OG002'}, {'value': '118.04', 'spread': '257.63', 'groupId': 'OG003'}, {'value': '241.23', 'spread': '332.43', 'groupId': 'OG004'}, {'value': '117.51', 'spread': '175.00', 'groupId': 'OG005'}, {'value': '152.19', 'spread': '297.33', 'groupId': 'OG006'}, {'value': '193.88', 'spread': '141.46', 'groupId': 'OG007'}, {'value': '126.64', 'spread': '402.92', 'groupId': 'OG008'}, {'value': '605.04', 'spread': '641.27', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-TNFα] at Day 21', 'categories': [{'measurements': [{'value': '509.26', 'spread': '451.20', 'groupId': 'OG000'}, {'value': '806.86', 'spread': '561.77', 'groupId': 'OG001'}, {'value': '601.64', 'spread': '763.90', 'groupId': 'OG002'}, {'value': '312.72', 'spread': '391.89', 'groupId': 'OG003'}, {'value': '518.35', 'spread': '419.60', 'groupId': 'OG004'}, {'value': '580.98', 'spread': '579.68', 'groupId': 'OG005'}, {'value': '547.64', 'spread': '464.44', 'groupId': 'OG006'}, {'value': '540.54', 'spread': '3022.19', 'groupId': 'OG007'}, {'value': '285.50', 'spread': '526.85', 'groupId': 'OG008'}, {'value': '805.41', 'spread': '1133.76', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 0 and 21', 'description': 'The markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD4-CD40Ligand(L), CD4-interferon gamma (CD4-IFNγ), CD4-interleukin 2 (CD4-IL2) and CD4-tumor necrosis factor alpha (CD4-TNFα). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.', 'unitOfMeasure': 'cells per million CD4 T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.'}, {'type': 'SECONDARY', 'title': 'The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'A/Solomon Islands [CD4-All doubles]', 'categories': [{'measurements': [{'value': '393.50', 'spread': '359.42', 'groupId': 'OG000'}, {'value': '348.12', 'spread': '422.44', 'groupId': 'OG001'}, {'value': '666.01', 'spread': '663.86', 'groupId': 'OG002'}, {'value': '394.45', 'spread': '508.40', 'groupId': 'OG003'}, {'value': '432.70', 'spread': '374.70', 'groupId': 'OG004'}, {'value': '421.08', 'spread': '613.81', 'groupId': 'OG005'}, {'value': '357.66', 'spread': '470.53', 'groupId': 'OG006'}, {'value': '224.47', 'spread': '332.47', 'groupId': 'OG007'}, {'value': '714.85', 'spread': '658.37', 'groupId': 'OG008'}, {'value': '1070.14', 'spread': '874.71', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-All doubles]', 'categories': [{'measurements': [{'value': '802.04', 'spread': '391.96', 'groupId': 'OG000'}, {'value': '603.15', 'spread': '559.07', 'groupId': 'OG001'}, {'value': '720.91', 'spread': '829.77', 'groupId': 'OG002'}, {'value': '463.85', 'spread': '832.67', 'groupId': 'OG003'}, {'value': '728.09', 'spread': '640.63', 'groupId': 'OG004'}, {'value': '676.69', 'spread': '785.39', 'groupId': 'OG005'}, {'value': '670.60', 'spread': '881.04', 'groupId': 'OG006'}, {'value': '566.79', 'spread': '522.16', 'groupId': 'OG007'}, {'value': '638.11', 'spread': '929.43', 'groupId': 'OG008'}, {'value': '1366.02', 'spread': '966.33', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-All doubles]', 'categories': [{'measurements': [{'value': '679.05', 'spread': '4150.67', 'groupId': 'OG000'}, {'value': '807.74', 'spread': '629.48', 'groupId': 'OG001'}, {'value': '807.96', 'spread': '901.44', 'groupId': 'OG002'}, {'value': '416.48', 'spread': '442.15', 'groupId': 'OG003'}, {'value': '774.07', 'spread': '452.40', 'groupId': 'OG004'}, {'value': '423.03', 'spread': '839.74', 'groupId': 'OG005'}, {'value': '582.68', 'spread': '429.62', 'groupId': 'OG006'}, {'value': '588.22', 'spread': '334.48', 'groupId': 'OG007'}, {'value': '742.01', 'spread': '481.80', 'groupId': 'OG008'}, {'value': '1304.54', 'spread': '1096.30', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD4-CD40L]', 'categories': [{'measurements': [{'value': '348.06', 'spread': '342.53', 'groupId': 'OG000'}, {'value': '319.80', 'spread': '403.11', 'groupId': 'OG001'}, {'value': '622.84', 'spread': '626.39', 'groupId': 'OG002'}, {'value': '361.05', 'spread': '490.66', 'groupId': 'OG003'}, {'value': '425.72', 'spread': '346.49', 'groupId': 'OG004'}, {'value': '471.70', 'spread': '566.40', 'groupId': 'OG005'}, {'value': '353.82', 'spread': '432.84', 'groupId': 'OG006'}, {'value': '234.90', 'spread': '304.83', 'groupId': 'OG007'}, {'value': '690.69', 'spread': '642.61', 'groupId': 'OG008'}, {'value': '999.02', 'spread': '831.24', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-CD40L]', 'categories': [{'measurements': [{'value': '733.96', 'spread': '397.17', 'groupId': 'OG000'}, {'value': '576.04', 'spread': '543.29', 'groupId': 'OG001'}, {'value': '682.43', 'spread': '823.68', 'groupId': 'OG002'}, {'value': '439.97', 'spread': '825.94', 'groupId': 'OG003'}, {'value': '680.00', 'spread': '607.45', 'groupId': 'OG004'}, {'value': '683.28', 'spread': '761.14', 'groupId': 'OG005'}, {'value': '623.11', 'spread': '800.89', 'groupId': 'OG006'}, {'value': '554.83', 'spread': '502.42', 'groupId': 'OG007'}, {'value': '625.97', 'spread': '924.73', 'groupId': 'OG008'}, {'value': '1268.21', 'spread': '889.54', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-CD40L]', 'categories': [{'measurements': [{'value': '621.50', 'spread': '3427.50', 'groupId': 'OG000'}, {'value': '764.21', 'spread': '613.38', 'groupId': 'OG001'}, {'value': '779.35', 'spread': '887.41', 'groupId': 'OG002'}, {'value': '394.05', 'spread': '415.93', 'groupId': 'OG003'}, {'value': '743.85', 'spread': '425.01', 'groupId': 'OG004'}, {'value': '414.76', 'spread': '732.26', 'groupId': 'OG005'}, {'value': '592.52', 'spread': '424.79', 'groupId': 'OG006'}, {'value': '537.41', 'spread': '351.86', 'groupId': 'OG007'}, {'value': '679.16', 'spread': '486.34', 'groupId': 'OG008'}, {'value': '1260.62', 'spread': '1067.54', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD4-IFNγ]', 'categories': [{'measurements': [{'value': '244.53', 'spread': '325.64', 'groupId': 'OG000'}, {'value': '375.03', 'spread': '308.38', 'groupId': 'OG001'}, {'value': '392.18', 'spread': '500.72', 'groupId': 'OG002'}, {'value': '280.73', 'spread': '402.63', 'groupId': 'OG003'}, {'value': '261.43', 'spread': '263.15', 'groupId': 'OG004'}, {'value': '338.11', 'spread': '488.06', 'groupId': 'OG005'}, {'value': '271.38', 'spread': '373.04', 'groupId': 'OG006'}, {'value': '136.97', 'spread': '262.56', 'groupId': 'OG007'}, {'value': '445.44', 'spread': '577.53', 'groupId': 'OG008'}, {'value': '867.78', 'spread': '658.04', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-IFNγ]', 'categories': [{'measurements': [{'value': '492.75', 'spread': '320.15', 'groupId': 'OG000'}, {'value': '476.37', 'spread': '416.85', 'groupId': 'OG001'}, {'value': '548.14', 'spread': '557.60', 'groupId': 'OG002'}, {'value': '372.77', 'spread': '618.70', 'groupId': 'OG003'}, {'value': '399.91', 'spread': '481.00', 'groupId': 'OG004'}, {'value': '325.70', 'spread': '547.57', 'groupId': 'OG005'}, {'value': '523.69', 'spread': '683.65', 'groupId': 'OG006'}, {'value': '374.66', 'spread': '407.51', 'groupId': 'OG007'}, {'value': '467.74', 'spread': '807.28', 'groupId': 'OG008'}, {'value': '971.26', 'spread': '783.42', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-IFNγ]', 'categories': [{'measurements': [{'value': '522.75', 'spread': '3348.47', 'groupId': 'OG000'}, {'value': '510.43', 'spread': '462.45', 'groupId': 'OG001'}, {'value': '457.89', 'spread': '774.10', 'groupId': 'OG002'}, {'value': '253.06', 'spread': '234.64', 'groupId': 'OG003'}, {'value': '411.84', 'spread': '384.77', 'groupId': 'OG004'}, {'value': '240.48', 'spread': '567.12', 'groupId': 'OG005'}, {'value': '361.94', 'spread': '357.95', 'groupId': 'OG006'}, {'value': '360.90', 'spread': '250.90', 'groupId': 'OG007'}, {'value': '458.80', 'spread': '456.80', 'groupId': 'OG008'}, {'value': '1073.05', 'spread': '935.35', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD4-IL2]', 'categories': [{'measurements': [{'value': '316.88', 'spread': '297.00', 'groupId': 'OG000'}, {'value': '314.96', 'spread': '372.22', 'groupId': 'OG001'}, {'value': '558.83', 'spread': '549.83', 'groupId': 'OG002'}, {'value': '304.00', 'spread': '404.11', 'groupId': 'OG003'}, {'value': '368.31', 'spread': '348.92', 'groupId': 'OG004'}, {'value': '400.05', 'spread': '505.26', 'groupId': 'OG005'}, {'value': '304.33', 'spread': '467.47', 'groupId': 'OG006'}, {'value': '175.36', 'spread': '258.68', 'groupId': 'OG007'}, {'value': '691.47', 'spread': '597.60', 'groupId': 'OG008'}, {'value': '859.06', 'spread': '642.57', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-IL2]', 'categories': [{'measurements': [{'value': '579.40', 'spread': '330.85', 'groupId': 'OG000'}, {'value': '426.54', 'spread': '422.19', 'groupId': 'OG001'}, {'value': '529.59', 'spread': '677.44', 'groupId': 'OG002'}, {'value': '480.46', 'spread': '667.59', 'groupId': 'OG003'}, {'value': '603.02', 'spread': '608.61', 'groupId': 'OG004'}, {'value': '551.29', 'spread': '712.29', 'groupId': 'OG005'}, {'value': '489.69', 'spread': '841.98', 'groupId': 'OG006'}, {'value': '339.94', 'spread': '440.33', 'groupId': 'OG007'}, {'value': '700.87', 'spread': '861.25', 'groupId': 'OG008'}, {'value': '1011.95', 'spread': '565.94', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-IL2]', 'categories': [{'measurements': [{'value': '549.00', 'spread': '2767.21', 'groupId': 'OG000'}, {'value': '617.40', 'spread': '602.01', 'groupId': 'OG001'}, {'value': '698.16', 'spread': '823.21', 'groupId': 'OG002'}, {'value': '315.90', 'spread': '393.50', 'groupId': 'OG003'}, {'value': '672.69', 'spread': '432.34', 'groupId': 'OG004'}, {'value': '373.28', 'spread': '680.43', 'groupId': 'OG005'}, {'value': '518.17', 'spread': '374.93', 'groupId': 'OG006'}, {'value': '345.05', 'spread': '300.46', 'groupId': 'OG007'}, {'value': '612.61', 'spread': '455.63', 'groupId': 'OG008'}, {'value': '1119.01', 'spread': '801.11', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD4-TNFα]', 'categories': [{'measurements': [{'value': '280.19', 'spread': '284.35', 'groupId': 'OG000'}, {'value': '188.48', 'spread': '325.58', 'groupId': 'OG001'}, {'value': '382.50', 'spread': '490.32', 'groupId': 'OG002'}, {'value': '200.30', 'spread': '422.18', 'groupId': 'OG003'}, {'value': '263.40', 'spread': '301.07', 'groupId': 'OG004'}, {'value': '350.38', 'spread': '473.03', 'groupId': 'OG005'}, {'value': '254.19', 'spread': '373.61', 'groupId': 'OG006'}, {'value': '228.89', 'spread': '247.41', 'groupId': 'OG007'}, {'value': '533.13', 'spread': '517.19', 'groupId': 'OG008'}, {'value': '730.49', 'spread': '549.49', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD4-TNFα]', 'categories': [{'measurements': [{'value': '722.29', 'spread': '288.16', 'groupId': 'OG000'}, {'value': '600.27', 'spread': '472.44', 'groupId': 'OG001'}, {'value': '626.23', 'spread': '655.14', 'groupId': 'OG002'}, {'value': '395.86', 'spread': '758.84', 'groupId': 'OG003'}, {'value': '599.10', 'spread': '496.66', 'groupId': 'OG004'}, {'value': '512.38', 'spread': '740.10', 'groupId': 'OG005'}, {'value': '601.79', 'spread': '703.08', 'groupId': 'OG006'}, {'value': '561.14', 'spread': '451.82', 'groupId': 'OG007'}, {'value': '521.03', 'spread': '873.58', 'groupId': 'OG008'}, {'value': '1187.70', 'spread': '734.12', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD4-TNFα]', 'categories': [{'measurements': [{'value': '538.21', 'spread': '2445.31', 'groupId': 'OG000'}, {'value': '576.09', 'spread': '352.91', 'groupId': 'OG001'}, {'value': '408.52', 'spread': '712.70', 'groupId': 'OG002'}, {'value': '149.41', 'spread': '359.72', 'groupId': 'OG003'}, {'value': '476.90', 'spread': '332.91', 'groupId': 'OG004'}, {'value': '160.26', 'spread': '542.67', 'groupId': 'OG005'}, {'value': '360.57', 'spread': '367.88', 'groupId': 'OG006'}, {'value': '385.22', 'spread': '227.19', 'groupId': 'OG007'}, {'value': '505.39', 'spread': '393.49', 'groupId': 'OG008'}, {'value': '798.97', 'spread': '716.33', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 180', 'description': 'The markers assessed were CD4-All doubles, CD4-CD40L, CD4-IFNγ, CD4-IL2 and CD4-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.', 'unitOfMeasure': 'cells per million CD4 T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on According-to-Protocol (ATP) cohort for persistence for cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 180.'}, {'type': 'SECONDARY', 'title': 'The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '23', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'A/Solomon Islands [CD8-All doubles] at Day 0', 'categories': [{'measurements': [{'value': '8.10', 'spread': '135.40', 'groupId': 'OG000'}, {'value': '12.90', 'spread': '151.71', 'groupId': 'OG001'}, {'value': '14.46', 'spread': '122.65', 'groupId': 'OG002'}, {'value': '3.25', 'spread': '53.78', 'groupId': 'OG003'}, {'value': '3.31', 'spread': '91.60', 'groupId': 'OG004'}, {'value': '2.31', 'spread': '47.88', 'groupId': 'OG005'}, {'value': '2.63', 'spread': '98.13', 'groupId': 'OG006'}, {'value': '6.83', 'spread': '67.42', 'groupId': 'OG007'}, {'value': '13.81', 'spread': '116.94', 'groupId': 'OG008'}, {'value': '7.69', 'spread': '91.40', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD8-All doubles] at Day 21', 'categories': [{'measurements': [{'value': '7.45', 'spread': '97.10', 'groupId': 'OG000'}, {'value': '12.20', 'spread': '127.89', 'groupId': 'OG001'}, {'value': '9.54', 'spread': '116.11', 'groupId': 'OG002'}, {'value': '5.14', 'spread': '87.63', 'groupId': 'OG003'}, {'value': '4.87', 'spread': '92.78', 'groupId': 'OG004'}, {'value': '4.71', 'spread': '49.37', 'groupId': 'OG005'}, {'value': '9.62', 'spread': '50.39', 'groupId': 'OG006'}, {'value': '4.76', 'spread': '132.76', 'groupId': 'OG007'}, {'value': '6.33', 'spread': '91.54', 'groupId': 'OG008'}, {'value': '2.34', 'spread': '132.36', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-All doubles] at Day 0', 'categories': [{'measurements': [{'value': '9.69', 'spread': '178.06', 'groupId': 'OG000'}, {'value': '6.81', 'spread': '126.03', 'groupId': 'OG001'}, {'value': '9.85', 'spread': '344.91', 'groupId': 'OG002'}, {'value': '3.93', 'spread': '124.78', 'groupId': 'OG003'}, {'value': '6.67', 'spread': '112.61', 'groupId': 'OG004'}, {'value': '5.53', 'spread': '169.17', 'groupId': 'OG005'}, {'value': '8.19', 'spread': '95.91', 'groupId': 'OG006'}, {'value': '6.73', 'spread': '108.10', 'groupId': 'OG007'}, {'value': '8.22', 'spread': '153.57', 'groupId': 'OG008'}, {'value': '9.16', 'spread': '63.84', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-All doubles] at Day 21', 'categories': [{'measurements': [{'value': '31.08', 'spread': '84.59', 'groupId': 'OG000'}, {'value': '7.54', 'spread': '234.23', 'groupId': 'OG001'}, {'value': '9.77', 'spread': '292.05', 'groupId': 'OG002'}, {'value': '4.15', 'spread': '66.82', 'groupId': 'OG003'}, {'value': '7.73', 'spread': '139.86', 'groupId': 'OG004'}, {'value': '12.49', 'spread': '189.06', 'groupId': 'OG005'}, {'value': '16.86', 'spread': '219.38', 'groupId': 'OG006'}, {'value': '4.99', 'spread': '168.28', 'groupId': 'OG007'}, {'value': '39.03', 'spread': '123.00', 'groupId': 'OG008'}, {'value': '2.00', 'spread': '57.24', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-All doubles] at Day 0', 'categories': [{'measurements': [{'value': '11.62', 'spread': '200.31', 'groupId': 'OG000'}, {'value': '15.68', 'spread': '423.52', 'groupId': 'OG001'}, {'value': '30.58', 'spread': '282.37', 'groupId': 'OG002'}, {'value': '10.85', 'spread': '215.20', 'groupId': 'OG003'}, {'value': '6.74', 'spread': '63.87', 'groupId': 'OG004'}, {'value': '2.48', 'spread': '44.95', 'groupId': 'OG005'}, {'value': '26.27', 'spread': '218.28', 'groupId': 'OG006'}, {'value': '23.57', 'spread': '184.06', 'groupId': 'OG007'}, {'value': '16.83', 'spread': '232.88', 'groupId': 'OG008'}, {'value': '11.02', 'spread': '175.35', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-All doubles] at Day 21', 'categories': [{'measurements': [{'value': '42.50', 'spread': '296.07', 'groupId': 'OG000'}, {'value': '44.96', 'spread': '351.05', 'groupId': 'OG001'}, {'value': '20.54', 'spread': '188.50', 'groupId': 'OG002'}, {'value': '8.09', 'spread': '302.34', 'groupId': 'OG003'}, {'value': '31.02', 'spread': '243.07', 'groupId': 'OG004'}, {'value': '22.20', 'spread': '183.56', 'groupId': 'OG005'}, {'value': '60.96', 'spread': '415.86', 'groupId': 'OG006'}, {'value': '13.39', 'spread': '193.75', 'groupId': 'OG007'}, {'value': '24.91', 'spread': '153.61', 'groupId': 'OG008'}, {'value': '16.20', 'spread': '225.18', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD8-CD40L] at Day 0', 'categories': [{'measurements': [{'value': '7.68', 'spread': '76.49', 'groupId': 'OG000'}, {'value': '9.18', 'spread': '141.09', 'groupId': 'OG001'}, {'value': '7.64', 'spread': '81.73', 'groupId': 'OG002'}, {'value': '2.31', 'spread': '25.28', 'groupId': 'OG003'}, {'value': '2.75', 'spread': '106.31', 'groupId': 'OG004'}, {'value': '1.47', 'spread': '26.08', 'groupId': 'OG005'}, {'value': '2.39', 'spread': '55.56', 'groupId': 'OG006'}, {'value': '2.94', 'spread': '67.71', 'groupId': 'OG007'}, {'value': '10.48', 'spread': '95.48', 'groupId': 'OG008'}, {'value': '2.70', 'spread': '77.94', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD8-CD40L] at Day 21', 'categories': [{'measurements': [{'value': '3.76', 'spread': '69.81', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '98.02', 'groupId': 'OG001'}, {'value': '8.71', 'spread': '75.81', 'groupId': 'OG002'}, {'value': '2.20', 'spread': '47.58', 'groupId': 'OG003'}, {'value': '3.22', 'spread': '72.42', 'groupId': 'OG004'}, {'value': '2.21', 'spread': '42.86', 'groupId': 'OG005'}, {'value': '3.36', 'spread': '55.81', 'groupId': 'OG006'}, {'value': '3.45', 'spread': '82.08', 'groupId': 'OG007'}, {'value': '2.30', 'spread': '53.40', 'groupId': 'OG008'}, {'value': '2.97', 'spread': '43.37', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-CD40L] at Day 0', 'categories': [{'measurements': [{'value': '4.63', 'spread': '51.86', 'groupId': 'OG000'}, {'value': '2.17', 'spread': '41.97', 'groupId': 'OG001'}, {'value': '5.20', 'spread': '70.37', 'groupId': 'OG002'}, {'value': '1.82', 'spread': '70.40', 'groupId': 'OG003'}, {'value': '2.78', 'spread': '66.95', 'groupId': 'OG004'}, {'value': '1.47', 'spread': '26.82', 'groupId': 'OG005'}, {'value': '3.10', 'spread': '43.93', 'groupId': 'OG006'}, {'value': '2.08', 'spread': '53.94', 'groupId': 'OG007'}, {'value': '4.55', 'spread': '93.16', 'groupId': 'OG008'}, {'value': '2.96', 'spread': '99.03', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-CD40L] at Day 21', 'categories': [{'measurements': [{'value': '3.09', 'spread': '45.67', 'groupId': 'OG000'}, {'value': '5.72', 'spread': '165.77', 'groupId': 'OG001'}, {'value': '4.19', 'spread': '52.99', 'groupId': 'OG002'}, {'value': '3.00', 'spread': '45.24', 'groupId': 'OG003'}, {'value': '5.72', 'spread': '90.85', 'groupId': 'OG004'}, {'value': '5.01', 'spread': '88.79', 'groupId': 'OG005'}, {'value': '5.58', 'spread': '98.17', 'groupId': 'OG006'}, {'value': '5.17', 'spread': '34.65', 'groupId': 'OG007'}, {'value': '7.27', 'spread': '43.58', 'groupId': 'OG008'}, {'value': '2.04', 'spread': '35.04', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-CD40L] at Day 0', 'categories': [{'measurements': [{'value': '3.24', 'spread': '54.73', 'groupId': 'OG000'}, {'value': '7.16', 'spread': '290.97', 'groupId': 'OG001'}, {'value': '6.53', 'spread': '132.89', 'groupId': 'OG002'}, {'value': '2.82', 'spread': '87.95', 'groupId': 'OG003'}, {'value': '2.84', 'spread': '47.37', 'groupId': 'OG004'}, {'value': '1.66', 'spread': '34.20', 'groupId': 'OG005'}, {'value': '3.29', 'spread': '76.69', 'groupId': 'OG006'}, {'value': '5.21', 'spread': '59.00', 'groupId': 'OG007'}, {'value': '5.52', 'spread': '168.72', 'groupId': 'OG008'}, {'value': '3.98', 'spread': '95.04', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-CD40L] at Day 21', 'categories': [{'measurements': [{'value': '2.68', 'spread': '127.60', 'groupId': 'OG000'}, {'value': '12.06', 'spread': '265.01', 'groupId': 'OG001'}, {'value': '3.74', 'spread': '115.89', 'groupId': 'OG002'}, {'value': '4.45', 'spread': '142.55', 'groupId': 'OG003'}, {'value': '9.13', 'spread': '183.09', 'groupId': 'OG004'}, {'value': '5.64', 'spread': '138.31', 'groupId': 'OG005'}, {'value': '8.97', 'spread': '271.08', 'groupId': 'OG006'}, {'value': '4.47', 'spread': '183.70', 'groupId': 'OG007'}, {'value': '3.43', 'spread': '72.64', 'groupId': 'OG008'}, {'value': '9.50', 'spread': '127.97', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD8-IFNγ] at Day 0', 'categories': [{'measurements': [{'value': '7.38', 'spread': '115.60', 'groupId': 'OG000'}, {'value': '8.63', 'spread': '157.70', 'groupId': 'OG001'}, {'value': '10.16', 'spread': '107.21', 'groupId': 'OG002'}, {'value': '3.99', 'spread': '62.89', 'groupId': 'OG003'}, {'value': '4.69', 'spread': '90.75', 'groupId': 'OG004'}, {'value': '1.89', 'spread': '57.50', 'groupId': 'OG005'}, {'value': '3.04', 'spread': '89.37', 'groupId': 'OG006'}, {'value': '6.83', 'spread': '63.62', 'groupId': 'OG007'}, {'value': '8.68', 'spread': '98.54', 'groupId': 'OG008'}, {'value': '4.59', 'spread': '65.86', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD8-IFNγ] at Day 21', 'categories': [{'measurements': [{'value': '7.37', 'spread': '84.04', 'groupId': 'OG000'}, {'value': '9.19', 'spread': '85.93', 'groupId': 'OG001'}, {'value': '11.15', 'spread': '94.57', 'groupId': 'OG002'}, {'value': '2.18', 'spread': '51.19', 'groupId': 'OG003'}, {'value': '3.96', 'spread': '75.52', 'groupId': 'OG004'}, {'value': '2.03', 'spread': '23.00', 'groupId': 'OG005'}, {'value': '5.60', 'spread': '50.57', 'groupId': 'OG006'}, {'value': '3.18', 'spread': '106.55', 'groupId': 'OG007'}, {'value': '3.25', 'spread': '64.56', 'groupId': 'OG008'}, {'value': '1.59', 'spread': '141.41', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-IFNγ] at Day 0', 'categories': [{'measurements': [{'value': '7.85', 'spread': '103.62', 'groupId': 'OG000'}, {'value': '3.95', 'spread': '78.12', 'groupId': 'OG001'}, {'value': '7.61', 'spread': '309.89', 'groupId': 'OG002'}, {'value': '2.46', 'spread': '120.14', 'groupId': 'OG003'}, {'value': '5.23', 'spread': '75.71', 'groupId': 'OG004'}, {'value': '2.51', 'spread': '168.10', 'groupId': 'OG005'}, {'value': '4.70', 'spread': '53.61', 'groupId': 'OG006'}, {'value': '4.05', 'spread': '52.57', 'groupId': 'OG007'}, {'value': '7.23', 'spread': '129.33', 'groupId': 'OG008'}, {'value': '7.26', 'spread': '64.60', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-IFNγ] at Day 21', 'categories': [{'measurements': [{'value': '8.27', 'spread': '78.96', 'groupId': 'OG000'}, {'value': '8.63', 'spread': '176.22', 'groupId': 'OG001'}, {'value': '9.89', 'spread': '295.99', 'groupId': 'OG002'}, {'value': '3.52', 'spread': '66.86', 'groupId': 'OG003'}, {'value': '6.18', 'spread': '125.90', 'groupId': 'OG004'}, {'value': '10.28', 'spread': '119.10', 'groupId': 'OG005'}, {'value': '12.07', 'spread': '140.10', 'groupId': 'OG006'}, {'value': '4.02', 'spread': '92.71', 'groupId': 'OG007'}, {'value': '6.94', 'spread': '109.72', 'groupId': 'OG008'}, {'value': '2.21', 'spread': '47.90', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-IFNγ] at Day 0', 'categories': [{'measurements': [{'value': '5.56', 'spread': '99.28', 'groupId': 'OG000'}, {'value': '10.71', 'spread': '390.44', 'groupId': 'OG001'}, {'value': '15.15', 'spread': '261.46', 'groupId': 'OG002'}, {'value': '6.09', 'spread': '157.93', 'groupId': 'OG003'}, {'value': '10.28', 'spread': '61.17', 'groupId': 'OG004'}, {'value': '1.69', 'spread': '19.96', 'groupId': 'OG005'}, {'value': '17.27', 'spread': '129.27', 'groupId': 'OG006'}, {'value': '17.76', 'spread': '137.26', 'groupId': 'OG007'}, {'value': '9.94', 'spread': '190.65', 'groupId': 'OG008'}, {'value': '9.07', 'spread': '168.50', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-IFNγ] at Day 21', 'categories': [{'measurements': [{'value': '11.69', 'spread': '129.41', 'groupId': 'OG000'}, {'value': '17.80', 'spread': '305.22', 'groupId': 'OG001'}, {'value': '14.44', 'spread': '160.52', 'groupId': 'OG002'}, {'value': '5.42', 'spread': '269.73', 'groupId': 'OG003'}, {'value': '14.05', 'spread': '224.41', 'groupId': 'OG004'}, {'value': '9.75', 'spread': '159.06', 'groupId': 'OG005'}, {'value': '23.95', 'spread': '323.71', 'groupId': 'OG006'}, {'value': '18.53', 'spread': '162.45', 'groupId': 'OG007'}, {'value': '21.99', 'spread': '122.96', 'groupId': 'OG008'}, {'value': '12.44', 'spread': '163.33', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD8-IL2] at Day 0', 'categories': [{'measurements': [{'value': '3.52', 'spread': '80.50', 'groupId': 'OG000'}, {'value': '3.10', 'spread': '27.39', 'groupId': 'OG001'}, {'value': '5.50', 'spread': '55.47', 'groupId': 'OG002'}, {'value': '3.03', 'spread': '42.10', 'groupId': 'OG003'}, {'value': '1.20', 'spread': '13.14', 'groupId': 'OG004'}, {'value': '2.12', 'spread': '30.13', 'groupId': 'OG005'}, {'value': '3.28', 'spread': '81.61', 'groupId': 'OG006'}, {'value': '2.96', 'spread': '40.40', 'groupId': 'OG007'}, {'value': '4.00', 'spread': '42.26', 'groupId': 'OG008'}, {'value': '2.67', 'spread': '38.98', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD8-IL2] at Day 21', 'categories': [{'measurements': [{'value': '4.80', 'spread': '63.95', 'groupId': 'OG000'}, {'value': '4.30', 'spread': '73.39', 'groupId': 'OG001'}, {'value': '7.50', 'spread': '51.96', 'groupId': 'OG002'}, {'value': '3.97', 'spread': '61.17', 'groupId': 'OG003'}, {'value': '1.98', 'spread': '40.41', 'groupId': 'OG004'}, {'value': '4.86', 'spread': '57.41', 'groupId': 'OG005'}, {'value': '4.36', 'spread': '36.32', 'groupId': 'OG006'}, {'value': '5.57', 'spread': '83.12', 'groupId': 'OG007'}, {'value': '7.30', 'spread': '69.21', 'groupId': 'OG008'}, {'value': '2.17', 'spread': '44.90', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-IL2] at Day 0', 'categories': [{'measurements': [{'value': '3.70', 'spread': '113.92', 'groupId': 'OG000'}, {'value': '3.21', 'spread': '91.01', 'groupId': 'OG001'}, {'value': '6.13', 'spread': '99.85', 'groupId': 'OG002'}, {'value': '3.13', 'spread': '61.75', 'groupId': 'OG003'}, {'value': '2.11', 'spread': '71.74', 'groupId': 'OG004'}, {'value': '4.05', 'spread': '62.37', 'groupId': 'OG005'}, {'value': '5.41', 'spread': '65.29', 'groupId': 'OG006'}, {'value': '6.43', 'spread': '82.32', 'groupId': 'OG007'}, {'value': '3.75', 'spread': '71.92', 'groupId': 'OG008'}, {'value': '2.00', 'spread': '23.96', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-IL2] at Day 21', 'categories': [{'measurements': [{'value': '12.45', 'spread': '89.54', 'groupId': 'OG000'}, {'value': '5.93', 'spread': '78.91', 'groupId': 'OG001'}, {'value': '7.70', 'spread': '64.46', 'groupId': 'OG002'}, {'value': '3.05', 'spread': '40.35', 'groupId': 'OG003'}, {'value': '2.97', 'spread': '61.70', 'groupId': 'OG004'}, {'value': '4.41', 'spread': '109.49', 'groupId': 'OG005'}, {'value': '10.92', 'spread': '109.83', 'groupId': 'OG006'}, {'value': '6.18', 'spread': '125.87', 'groupId': 'OG007'}, {'value': '14.11', 'spread': '81.52', 'groupId': 'OG008'}, {'value': '2.69', 'spread': '51.22', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-IL2] at Day 0', 'categories': [{'measurements': [{'value': '8.66', 'spread': '147.36', 'groupId': 'OG000'}, {'value': '4.40', 'spread': '161.85', 'groupId': 'OG001'}, {'value': '10.05', 'spread': '141.49', 'groupId': 'OG002'}, {'value': '9.50', 'spread': '106.18', 'groupId': 'OG003'}, {'value': '2.13', 'spread': '22.15', 'groupId': 'OG004'}, {'value': '2.66', 'spread': '49.28', 'groupId': 'OG005'}, {'value': '12.10', 'spread': '182.42', 'groupId': 'OG006'}, {'value': '17.14', 'spread': '88.20', 'groupId': 'OG007'}, {'value': '6.41', 'spread': '108.44', 'groupId': 'OG008'}, {'value': '2.17', 'spread': '64.13', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-IL2] at Day 21', 'categories': [{'measurements': [{'value': '17.85', 'spread': '257.14', 'groupId': 'OG000'}, {'value': '32.92', 'spread': '72.84', 'groupId': 'OG001'}, {'value': '9.72', 'spread': '118.83', 'groupId': 'OG002'}, {'value': '4.83', 'spread': '129.69', 'groupId': 'OG003'}, {'value': '7.60', 'spread': '27.90', 'groupId': 'OG004'}, {'value': '8.49', 'spread': '137.21', 'groupId': 'OG005'}, {'value': '17.98', 'spread': '127.27', 'groupId': 'OG006'}, {'value': '5.19', 'spread': '81.07', 'groupId': 'OG007'}, {'value': '7.95', 'spread': '75.16', 'groupId': 'OG008'}, {'value': '12.46', 'spread': '96.16', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD8-TNFα] at Day 0', 'categories': [{'measurements': [{'value': '5.41', 'spread': '91.54', 'groupId': 'OG000'}, {'value': '3.26', 'spread': '34.12', 'groupId': 'OG001'}, {'value': '8.71', 'spread': '71.14', 'groupId': 'OG002'}, {'value': '2.59', 'spread': '42.20', 'groupId': 'OG003'}, {'value': '2.58', 'spread': '39.14', 'groupId': 'OG004'}, {'value': '2.28', 'spread': '45.26', 'groupId': 'OG005'}, {'value': '2.18', 'spread': '33.72', 'groupId': 'OG006'}, {'value': '5.63', 'spread': '58.18', 'groupId': 'OG007'}, {'value': '3.94', 'spread': '52.44', 'groupId': 'OG008'}, {'value': '4.33', 'spread': '81.83', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD8-TNFα] at Day 21', 'categories': [{'measurements': [{'value': '3.79', 'spread': '79.93', 'groupId': 'OG000'}, {'value': '12.15', 'spread': '70.97', 'groupId': 'OG001'}, {'value': '2.76', 'spread': '117.87', 'groupId': 'OG002'}, {'value': '5.85', 'spread': '65.60', 'groupId': 'OG003'}, {'value': '2.68', 'spread': '61.45', 'groupId': 'OG004'}, {'value': '3.78', 'spread': '51.36', 'groupId': 'OG005'}, {'value': '5.33', 'spread': '36.95', 'groupId': 'OG006'}, {'value': '6.03', 'spread': '110.26', 'groupId': 'OG007'}, {'value': '4.35', 'spread': '64.50', 'groupId': 'OG008'}, {'value': '1.91', 'spread': '131.67', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-TNFα] at Day 0', 'categories': [{'measurements': [{'value': '5.04', 'spread': '145.40', 'groupId': 'OG000'}, {'value': '3.70', 'spread': '138.04', 'groupId': 'OG001'}, {'value': '5.31', 'spread': '338.73', 'groupId': 'OG002'}, {'value': '3.70', 'spread': '67.70', 'groupId': 'OG003'}, {'value': '8.64', 'spread': '86.13', 'groupId': 'OG004'}, {'value': '9.54', 'spread': '187.33', 'groupId': 'OG005'}, {'value': '5.96', 'spread': '128.54', 'groupId': 'OG006'}, {'value': '10.06', 'spread': '78.63', 'groupId': 'OG007'}, {'value': '3.93', 'spread': '93.43', 'groupId': 'OG008'}, {'value': '3.41', 'spread': '64.37', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-TNFα] at Day 21', 'categories': [{'measurements': [{'value': '14.64', 'spread': '98.80', 'groupId': 'OG000'}, {'value': '5.75', 'spread': '118.21', 'groupId': 'OG001'}, {'value': '5.74', 'spread': '278.42', 'groupId': 'OG002'}, {'value': '3.47', 'spread': '65.17', 'groupId': 'OG003'}, {'value': '5.60', 'spread': '66.01', 'groupId': 'OG004'}, {'value': '12.32', 'spread': '188.66', 'groupId': 'OG005'}, {'value': '11.29', 'spread': '211.80', 'groupId': 'OG006'}, {'value': '8.52', 'spread': '135.47', 'groupId': 'OG007'}, {'value': '16.28', 'spread': '142.20', 'groupId': 'OG008'}, {'value': '2.52', 'spread': '46.95', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-TNFα] at Day 0', 'categories': [{'measurements': [{'value': '11.49', 'spread': '167.40', 'groupId': 'OG000'}, {'value': '11.28', 'spread': '215.17', 'groupId': 'OG001'}, {'value': '18.47', 'spread': '194.16', 'groupId': 'OG002'}, {'value': '8.77', 'spread': '177.85', 'groupId': 'OG003'}, {'value': '6.77', 'spread': '50.82', 'groupId': 'OG004'}, {'value': '2.67', 'spread': '37.22', 'groupId': 'OG005'}, {'value': '26.25', 'spread': '172.19', 'groupId': 'OG006'}, {'value': '23.27', 'spread': '109.52', 'groupId': 'OG007'}, {'value': '14.97', 'spread': '169.37', 'groupId': 'OG008'}, {'value': '9.07', 'spread': '123.64', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-TNFα] at Day 21', 'categories': [{'measurements': [{'value': '28.50', 'spread': '261.61', 'groupId': 'OG000'}, {'value': '13.76', 'spread': '122.97', 'groupId': 'OG001'}, {'value': '9.28', 'spread': '142.76', 'groupId': 'OG002'}, {'value': '9.21', 'spread': '224.57', 'groupId': 'OG003'}, {'value': '15.20', 'spread': '160.37', 'groupId': 'OG004'}, {'value': '9.02', 'spread': '96.93', 'groupId': 'OG005'}, {'value': '27.84', 'spread': '355.89', 'groupId': 'OG006'}, {'value': '15.64', 'spread': '126.07', 'groupId': 'OG007'}, {'value': '19.42', 'spread': '124.13', 'groupId': 'OG008'}, {'value': '8.57', 'spread': '151.66', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Days 0 and 21', 'description': 'The markers assessed were Cluster of Differentiation 8-All doubles i.e. CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.', 'unitOfMeasure': 'cells per million CD8 T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity cell mediated immunity (CMI) which included subjects for whom data concerning immunogenicity CMI outcome measures were available at day 21.'}, {'type': 'SECONDARY', 'title': 'The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'A/Solomon Islands [CD8-All doubles]', 'categories': [{'measurements': [{'value': '2.57', 'spread': '89.78', 'groupId': 'OG000'}, {'value': '14.64', 'spread': '96.62', 'groupId': 'OG001'}, {'value': '3.61', 'spread': '143.10', 'groupId': 'OG002'}, {'value': '4.75', 'spread': '74.09', 'groupId': 'OG003'}, {'value': '3.05', 'spread': '107.06', 'groupId': 'OG004'}, {'value': '1.24', 'spread': '15.43', 'groupId': 'OG005'}, {'value': '2.64', 'spread': '47.18', 'groupId': 'OG006'}, {'value': '4.81', 'spread': '90.76', 'groupId': 'OG007'}, {'value': '7.32', 'spread': '115.74', 'groupId': 'OG008'}, {'value': '5.64', 'spread': '98.76', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-All doubles]', 'categories': [{'measurements': [{'value': '21.14', 'spread': '506.65', 'groupId': 'OG000'}, {'value': '9.63', 'spread': '110.40', 'groupId': 'OG001'}, {'value': '18.10', 'spread': '367.31', 'groupId': 'OG002'}, {'value': '16.14', 'spread': '132.83', 'groupId': 'OG003'}, {'value': '20.72', 'spread': '412.35', 'groupId': 'OG004'}, {'value': '21.73', 'spread': '368.70', 'groupId': 'OG005'}, {'value': '21.00', 'spread': '327.24', 'groupId': 'OG006'}, {'value': '11.95', 'spread': '384.28', 'groupId': 'OG007'}, {'value': '10.44', 'spread': '226.57', 'groupId': 'OG008'}, {'value': '3.13', 'spread': '186.12', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-All doubles]', 'categories': [{'measurements': [{'value': '9.92', 'spread': '111.75', 'groupId': 'OG000'}, {'value': '7.10', 'spread': '132.35', 'groupId': 'OG001'}, {'value': '12.14', 'spread': '319.23', 'groupId': 'OG002'}, {'value': '9.61', 'spread': '157.68', 'groupId': 'OG003'}, {'value': '25.48', 'spread': '138.45', 'groupId': 'OG004'}, {'value': '9.18', 'spread': '143.21', 'groupId': 'OG005'}, {'value': '12.73', 'spread': '460.97', 'groupId': 'OG006'}, {'value': '4.71', 'spread': '115.31', 'groupId': 'OG007'}, {'value': '6.47', 'spread': '83.62', 'groupId': 'OG008'}, {'value': '7.96', 'spread': '132.07', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD8-CD40L]', 'categories': [{'measurements': [{'value': '2.92', 'spread': '53.08', 'groupId': 'OG000'}, {'value': '12.64', 'spread': '119.84', 'groupId': 'OG001'}, {'value': '2.95', 'spread': '97.98', 'groupId': 'OG002'}, {'value': '3.18', 'spread': '74.24', 'groupId': 'OG003'}, {'value': '3.97', 'spread': '69.10', 'groupId': 'OG004'}, {'value': '1.93', 'spread': '31.31', 'groupId': 'OG005'}, {'value': '2.70', 'spread': '59.56', 'groupId': 'OG006'}, {'value': '4.89', 'spread': '86.67', 'groupId': 'OG007'}, {'value': '8.74', 'spread': '100.11', 'groupId': 'OG008'}, {'value': '3.94', 'spread': '40.79', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-CD40L]', 'categories': [{'measurements': [{'value': '18.75', 'spread': '312.61', 'groupId': 'OG000'}, {'value': '7.79', 'spread': '60.25', 'groupId': 'OG001'}, {'value': '10.73', 'spread': '230.49', 'groupId': 'OG002'}, {'value': '15.32', 'spread': '145.70', 'groupId': 'OG003'}, {'value': '9.60', 'spread': '232.78', 'groupId': 'OG004'}, {'value': '8.57', 'spread': '321.14', 'groupId': 'OG005'}, {'value': '13.90', 'spread': '118.80', 'groupId': 'OG006'}, {'value': '6.00', 'spread': '315.87', 'groupId': 'OG007'}, {'value': '6.46', 'spread': '135.88', 'groupId': 'OG008'}, {'value': '3.43', 'spread': '66.51', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-CD40L]', 'categories': [{'measurements': [{'value': '5.79', 'spread': '103.71', 'groupId': 'OG000'}, {'value': '5.64', 'spread': '75.90', 'groupId': 'OG001'}, {'value': '10.61', 'spread': '125.46', 'groupId': 'OG002'}, {'value': '7.48', 'spread': '92.38', 'groupId': 'OG003'}, {'value': '8.46', 'spread': '105.02', 'groupId': 'OG004'}, {'value': '6.10', 'spread': '113.43', 'groupId': 'OG005'}, {'value': '3.77', 'spread': '59.02', 'groupId': 'OG006'}, {'value': '2.75', 'spread': '73.05', 'groupId': 'OG007'}, {'value': '3.63', 'spread': '81.37', 'groupId': 'OG008'}, {'value': '3.78', 'spread': '95.38', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD8-IFNγ]', 'categories': [{'measurements': [{'value': '2.00', 'spread': '54.66', 'groupId': 'OG000'}, {'value': '3.12', 'spread': '124.76', 'groupId': 'OG001'}, {'value': '3.13', 'spread': '50.16', 'groupId': 'OG002'}, {'value': '3.89', 'spread': '53.23', 'groupId': 'OG003'}, {'value': '1.90', 'spread': '35.38', 'groupId': 'OG004'}, {'value': '3.12', 'spread': '47.02', 'groupId': 'OG005'}, {'value': '3.07', 'spread': '31.51', 'groupId': 'OG006'}, {'value': '3.11', 'spread': '45.39', 'groupId': 'OG007'}, {'value': '2.36', 'spread': '55.08', 'groupId': 'OG008'}, {'value': '2.65', 'spread': '79.58', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-IFNγ]', 'categories': [{'measurements': [{'value': '4.21', 'spread': '167.18', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '42.60', 'groupId': 'OG001'}, {'value': '2.32', 'spread': '92.50', 'groupId': 'OG002'}, {'value': '2.89', 'spread': '43.98', 'groupId': 'OG003'}, {'value': '2.50', 'spread': '53.46', 'groupId': 'OG004'}, {'value': '2.53', 'spread': '46.46', 'groupId': 'OG005'}, {'value': '2.39', 'spread': '154.17', 'groupId': 'OG006'}, {'value': '3.67', 'spread': '78.90', 'groupId': 'OG007'}, {'value': '1.97', 'spread': '157.41', 'groupId': 'OG008'}, {'value': '2.72', 'spread': '125.70', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-IFNγ]', 'categories': [{'measurements': [{'value': '10.63', 'spread': '76.06', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '66.40', 'groupId': 'OG001'}, {'value': '6.46', 'spread': '183.07', 'groupId': 'OG002'}, {'value': '6.19', 'spread': '170.54', 'groupId': 'OG003'}, {'value': '10.24', 'spread': '49.87', 'groupId': 'OG004'}, {'value': '4.96', 'spread': '55.70', 'groupId': 'OG005'}, {'value': '8.54', 'spread': '430.43', 'groupId': 'OG006'}, {'value': '2.56', 'spread': '40.61', 'groupId': 'OG007'}, {'value': '4.12', 'spread': '49.87', 'groupId': 'OG008'}, {'value': '5.33', 'spread': '182.33', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD8-IL2]', 'categories': [{'measurements': [{'value': '1.97', 'spread': '64.78', 'groupId': 'OG000'}, {'value': '10.49', 'spread': '74.37', 'groupId': 'OG001'}, {'value': '2.82', 'spread': '105.05', 'groupId': 'OG002'}, {'value': '3.36', 'spread': '44.53', 'groupId': 'OG003'}, {'value': '3.76', 'spread': '68.56', 'groupId': 'OG004'}, {'value': '1.89', 'spread': '25.49', 'groupId': 'OG005'}, {'value': '4.31', 'spread': '70.92', 'groupId': 'OG006'}, {'value': '4.89', 'spread': '86.67', 'groupId': 'OG007'}, {'value': '4.93', 'spread': '111.36', 'groupId': 'OG008'}, {'value': '7.15', 'spread': '75.19', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-IL2]', 'categories': [{'measurements': [{'value': '20.60', 'spread': '427.25', 'groupId': 'OG000'}, {'value': '15.24', 'spread': '108.11', 'groupId': 'OG001'}, {'value': '14.05', 'spread': '351.12', 'groupId': 'OG002'}, {'value': '42.75', 'spread': '112.35', 'groupId': 'OG003'}, {'value': '19.37', 'spread': '415.28', 'groupId': 'OG004'}, {'value': '32.48', 'spread': '357.67', 'groupId': 'OG005'}, {'value': '15.96', 'spread': '296.44', 'groupId': 'OG006'}, {'value': '11.89', 'spread': '385.26', 'groupId': 'OG007'}, {'value': '10.37', 'spread': '212.91', 'groupId': 'OG008'}, {'value': '4.04', 'spread': '153.21', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-IL2]', 'categories': [{'measurements': [{'value': '4.15', 'spread': '92.98', 'groupId': 'OG000'}, {'value': '7.59', 'spread': '100.66', 'groupId': 'OG001'}, {'value': '11.05', 'spread': '217.46', 'groupId': 'OG002'}, {'value': '7.47', 'spread': '77.13', 'groupId': 'OG003'}, {'value': '11.50', 'spread': '130.60', 'groupId': 'OG004'}, {'value': '11.62', 'spread': '176.05', 'groupId': 'OG005'}, {'value': '3.86', 'spread': '81.13', 'groupId': 'OG006'}, {'value': '5.99', 'spread': '110.92', 'groupId': 'OG007'}, {'value': '4.38', 'spread': '95.85', 'groupId': 'OG008'}, {'value': '6.11', 'spread': '91.97', 'groupId': 'OG009'}]}]}, {'title': 'A/Solomon Islands [CD8-TNFα]', 'categories': [{'measurements': [{'value': '2.54', 'spread': '60.55', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '31.14', 'groupId': 'OG001'}, {'value': '2.09', 'spread': '62.82', 'groupId': 'OG002'}, {'value': '3.60', 'spread': '37.07', 'groupId': 'OG003'}, {'value': '1.62', 'spread': '76.42', 'groupId': 'OG004'}, {'value': '1.53', 'spread': '21.24', 'groupId': 'OG005'}, {'value': '2.44', 'spread': '28.80', 'groupId': 'OG006'}, {'value': '2.73', 'spread': '44.50', 'groupId': 'OG007'}, {'value': '2.54', 'spread': '79.84', 'groupId': 'OG008'}, {'value': '3.39', 'spread': '69.30', 'groupId': 'OG009'}]}]}, {'title': 'A/Wisconsin [CD8-TNFα]', 'categories': [{'measurements': [{'value': '7.78', 'spread': '244.26', 'groupId': 'OG000'}, {'value': '4.42', 'spread': '63.49', 'groupId': 'OG001'}, {'value': '9.25', 'spread': '151.69', 'groupId': 'OG002'}, {'value': '6.69', 'spread': '85.85', 'groupId': 'OG003'}, {'value': '6.67', 'spread': '210.64', 'groupId': 'OG004'}, {'value': '3.26', 'spread': '108.02', 'groupId': 'OG005'}, {'value': '9.09', 'spread': '213.44', 'groupId': 'OG006'}, {'value': '4.86', 'spread': '78.63', 'groupId': 'OG007'}, {'value': '6.81', 'spread': '139.38', 'groupId': 'OG008'}, {'value': '3.52', 'spread': '125.46', 'groupId': 'OG009'}]}]}, {'title': 'B/Malaysia [CD8-TNFα]', 'categories': [{'measurements': [{'value': '4.05', 'spread': '74.16', 'groupId': 'OG000'}, {'value': '5.66', 'spread': '88.74', 'groupId': 'OG001'}, {'value': '14.08', 'spread': '191.59', 'groupId': 'OG002'}, {'value': '3.84', 'spread': '93.04', 'groupId': 'OG003'}, {'value': '6.11', 'spread': '48.41', 'groupId': 'OG004'}, {'value': '5.46', 'spread': '88.95', 'groupId': 'OG005'}, {'value': '5.07', 'spread': '415.90', 'groupId': 'OG006'}, {'value': '3.63', 'spread': '81.27', 'groupId': 'OG007'}, {'value': '4.69', 'spread': '42.36', 'groupId': 'OG008'}, {'value': '4.58', 'spread': '132.21', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 180', 'description': 'The markers assessed were CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.', 'unitOfMeasure': 'cells per million CD8 T-cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on According-to-Protocol (ATP) cohort for persistence for cell mediated immunity (CMI) which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available at day 180.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}, {'value': '198', 'groupId': 'OG004'}, {'value': '197', 'groupId': 'OG005'}, {'value': '198', 'groupId': 'OG006'}, {'value': '198', 'groupId': 'OG007'}, {'value': '200', 'groupId': 'OG008'}, {'value': '201', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'Any ecchymosis', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 ecchymosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Any pain', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}, {'value': '119', 'groupId': 'OG005'}, {'value': '93', 'groupId': 'OG006'}, {'value': '106', 'groupId': 'OG007'}, {'value': '32', 'groupId': 'OG008'}, {'value': '93', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Any redness', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '34', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 redness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Any swelling', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During a 7-day follow-up period (Day 0-6) after vaccination', 'description': 'Grade 3 ecchymosis, pain, redness and swelling was greater than 100 millimeter (mm) i.e. \\> 100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was \\>20mm.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.'}, {'type': 'SECONDARY', 'title': 'Duration of Solicited Local AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}, {'value': '119', 'groupId': 'OG005'}, {'value': '93', 'groupId': 'OG006'}, {'value': '106', 'groupId': 'OG007'}, {'value': '32', 'groupId': 'OG008'}, {'value': '93', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'Ecchymosis (N=3;1;5;1;2;2;4;2;3;0)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '6.0'}, {'value': '6.0', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '2.0'}, {'value': '2.5', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '3.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG007', 'lowerLimit': '2.0', 'upperLimit': '4.0'}, {'value': '5.0', 'groupId': 'OG008', 'lowerLimit': '4.0', 'upperLimit': '7.0'}, {'value': 'NA', 'comment': 'None of the subjects in this group reported any ecchymosis.', 'groupId': 'OG009', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Pain (N=68;82;111;84;91;119;93;106;32;93)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG008', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG009', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Redness (N=14;16;35;11;33;36;18;34;5;2)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '3.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '3.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG008', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '1.0', 'groupId': 'OG009', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}, {'title': 'Swelling (N=12;12;24;12;17;23;11;25;5;2)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '3.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG008', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '1.5', 'groupId': 'OG009', 'lowerLimit': '1.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During a 7-day follow-up period (Day 0-6) after vaccination', 'description': 'Duration was defined as number of days with any grade of local symptoms.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom and completed information on duration in their symptom sheet.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}, {'value': '198', 'groupId': 'OG004'}, {'value': '198', 'groupId': 'OG005'}, {'value': '198', 'groupId': 'OG006'}, {'value': '198', 'groupId': 'OG007'}, {'value': '200', 'groupId': 'OG008'}, {'value': '201', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'Any arthralgia', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '28', 'groupId': 'OG006'}, {'value': '35', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 arthralgia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Related arthralgia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}]}]}, {'title': 'Any fatigue', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '63', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '41', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'Related fatigue', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}, {'value': '35', 'groupId': 'OG007'}, {'value': '16', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}]}, {'title': 'Any headache', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '48', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '45', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 headache', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Related headache', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '20', 'groupId': 'OG008'}, {'value': '30', 'groupId': 'OG009'}]}]}, {'title': 'Any myalgia', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '56', 'groupId': 'OG007'}, {'value': '19', 'groupId': 'OG008'}, {'value': '40', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 myalgia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'Related myalgia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '44', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '33', 'groupId': 'OG009'}]}]}, {'title': 'Any nausea', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Related nausea', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}]}]}, {'title': 'Any shivering', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '31', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '21', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 shivering', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'Related shivering', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '16', 'groupId': 'OG009'}]}]}, {'title': 'Any fever', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Related fever', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During a 7-day follow-up period (Day 0-6) after vaccination', 'description': 'Any Fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e.≥ 38.0°C, grade 3 fever was axillary temperature \\>40°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.'}, {'type': 'SECONDARY', 'title': 'Duration of Solicited General AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '63', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}, {'value': '45', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'Arthralgia (N=15;23;36;16;21;45;28;35;16;12)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '3.0', 'groupId': 'OG008', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG009', 'lowerLimit': '1.0', 'upperLimit': '6.0'}]}]}, {'title': 'Fatigue (N=34;35;54;35;46;55;38;63;24;41)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG008', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG009', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Headache (N=22;38;47;35;39;55;36;48;23;45)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '1.5', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '1.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG008', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG009', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Myalgia (N=20;35;57;30;47;66;46;56;19;40)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG008', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG009', 'lowerLimit': '1.0', 'upperLimit': '7.0'}]}]}, {'title': 'Nausea (N=10;12;19;10;13;18;8;14;6;13)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '1.5', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '1.0', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '1.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '1.5', 'groupId': 'OG008', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG009', 'lowerLimit': '1.0', 'upperLimit': '6.0'}]}]}, {'title': 'Shivering (N=13;18;37;26;18;43;17;31;8;21)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '1.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '1.0', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '2.5', 'groupId': 'OG008', 'lowerLimit': '1.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG009', 'lowerLimit': '1.0', 'upperLimit': '6.0'}]}]}, {'title': 'Fever (N=4;3;9;4;3;14;6;12;0;1)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '3.0'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.5', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '1.0', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '2.0'}, {'value': 'NA', 'comment': 'None of the subjects in this group reported any fever.', 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.0', 'groupId': 'OG009', 'lowerLimit': '1.0', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During a 7-day follow-up period (Day 0-6) after vaccination', 'description': 'Duration was defined as number of days with any grade of general symptoms.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom and completed information on duration in their symptom sheet.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}, {'value': '199', 'groupId': 'OG004'}, {'value': '198', 'groupId': 'OG005'}, {'value': '198', 'groupId': 'OG006'}, {'value': '199', 'groupId': 'OG007'}, {'value': '200', 'groupId': 'OG008'}, {'value': '203', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'Any AE(s)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '43', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}, {'value': '44', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 AE(s)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}]}, {'title': 'Related AE(s)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During a 21-day follow-up period (Day 0-20) after vaccination', 'description': 'Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}, {'value': '199', 'groupId': 'OG004'}, {'value': '198', 'groupId': 'OG005'}, {'value': '198', 'groupId': 'OG006'}, {'value': '199', 'groupId': 'OG007'}, {'value': '200', 'groupId': 'OG008'}, {'value': '203', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'Any AE(S)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 AE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'Related AE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 0 and Day 20 after vaccination', 'description': 'For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}, {'value': '199', 'groupId': 'OG004'}, {'value': '198', 'groupId': 'OG005'}, {'value': '198', 'groupId': 'OG006'}, {'value': '199', 'groupId': 'OG007'}, {'value': '200', 'groupId': 'OG008'}, {'value': '203', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'Any AE (s)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}, {'value': '67', 'groupId': 'OG005'}, {'value': '67', 'groupId': 'OG006'}, {'value': '69', 'groupId': 'OG007'}, {'value': '69', 'groupId': 'OG008'}, {'value': '62', 'groupId': 'OG009'}]}]}, {'title': 'Grade 3 AE(s)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}]}]}, {'title': 'Related AE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 21 and Day 179 after vaccination', 'description': 'For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}, {'value': '199', 'groupId': 'OG004'}, {'value': '198', 'groupId': 'OG005'}, {'value': '198', 'groupId': 'OG006'}, {'value': '199', 'groupId': 'OG007'}, {'value': '200', 'groupId': 'OG008'}, {'value': '203', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'Any SAE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Related SAE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 0 and Day 20 after vaccination', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}, {'value': '199', 'groupId': 'OG004'}, {'value': '198', 'groupId': 'OG005'}, {'value': '198', 'groupId': 'OG006'}, {'value': '199', 'groupId': 'OG007'}, {'value': '200', 'groupId': 'OG008'}, {'value': '203', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'OG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'OG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'classes': [{'title': 'Any SAE(s)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}]}, {'title': 'Related SAE(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 21 and Day 179 after vaccination', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'FG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'FG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'FG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'FG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'FG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'FG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'FG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'FG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'FG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '202'}, {'groupId': 'FG002', 'numSubjects': '202'}, {'groupId': 'FG003', 'numSubjects': '202'}, {'groupId': 'FG004', 'numSubjects': '199'}, {'groupId': 'FG005', 'numSubjects': '198'}, {'groupId': 'FG006', 'numSubjects': '198'}, {'groupId': 'FG007', 'numSubjects': '199'}, {'groupId': 'FG008', 'numSubjects': '200'}, {'groupId': 'FG009', 'numSubjects': '203'}]}, {'type': 'Completed at Day 180', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '201'}, {'groupId': 'FG002', 'numSubjects': '197'}, {'groupId': 'FG003', 'numSubjects': '197'}, {'groupId': 'FG004', 'numSubjects': '195'}, {'groupId': 'FG005', 'numSubjects': '198'}, {'groupId': 'FG006', 'numSubjects': '196'}, {'groupId': 'FG007', 'numSubjects': '193'}, {'groupId': 'FG008', 'numSubjects': '198'}, {'groupId': 'FG009', 'numSubjects': '189'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '201'}, {'groupId': 'FG002', 'numSubjects': '201'}, {'groupId': 'FG003', 'numSubjects': '201'}, {'groupId': 'FG004', 'numSubjects': '198'}, {'groupId': 'FG005', 'numSubjects': '198'}, {'groupId': 'FG006', 'numSubjects': '198'}, {'groupId': 'FG007', 'numSubjects': '198'}, {'groupId': 'FG008', 'numSubjects': '199'}, {'groupId': 'FG009', 'numSubjects': '201'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '202', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}, {'value': '198', 'groupId': 'BG005'}, {'value': '198', 'groupId': 'BG006'}, {'value': '199', 'groupId': 'BG007'}, {'value': '200', 'groupId': 'BG008'}, {'value': '203', 'groupId': 'BG009'}, {'value': '2007', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Influenza Vaccine GSK576389A Formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'BG001', 'title': 'Influenza Vaccine GSK576389A Formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'BG002', 'title': 'Influenza Vaccine GSK576389A Formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'BG003', 'title': 'Influenza Vaccine GSK576389A Formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'BG004', 'title': 'Influenza Vaccine GSK576389A Formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'BG005', 'title': 'Influenza Vaccine GSK576389A Formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'BG006', 'title': 'Influenza Vaccine GSK576389A Formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'BG007', 'title': 'Influenza Vaccine GSK576389A Formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.'}, {'id': 'BG008', 'title': 'Fluarix Elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.'}, {'id': 'BG009', 'title': 'Fluarix Young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'spread': '5.75', 'groupId': 'BG000'}, {'value': '72.6', 'spread': '5.16', 'groupId': 'BG001'}, {'value': '72.4', 'spread': '5.62', 'groupId': 'BG002'}, {'value': '72.9', 'spread': '6.09', 'groupId': 'BG003'}, {'value': '72.6', 'spread': '5.66', 'groupId': 'BG004'}, {'value': '72.7', 'spread': '5.56', 'groupId': 'BG005'}, {'value': '72.6', 'spread': '5.67', 'groupId': 'BG006'}, {'value': '73.0', 'spread': '6.03', 'groupId': 'BG007'}, {'value': '72.7', 'spread': '5.43', 'groupId': 'BG008'}, {'value': '27.4', 'spread': '6.25', 'groupId': 'BG009'}, {'value': '68.11', 'spread': '14.81', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '89', 'groupId': 'BG004'}, {'value': '102', 'groupId': 'BG005'}, {'value': '96', 'groupId': 'BG006'}, {'value': '95', 'groupId': 'BG007'}, {'value': '90', 'groupId': 'BG008'}, {'value': '103', 'groupId': 'BG009'}, {'value': '984', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}, {'value': '96', 'groupId': 'BG005'}, {'value': '102', 'groupId': 'BG006'}, {'value': '104', 'groupId': 'BG007'}, {'value': '110', 'groupId': 'BG008'}, {'value': '100', 'groupId': 'BG009'}, {'value': '1023', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2007}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'dispFirstSubmitDate': '2009-05-20', 'completionDateStruct': {'date': '2008-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-09', 'studyFirstSubmitDate': '2007-10-05', 'dispFirstSubmitQcDate': '2009-05-21', 'resultsFirstSubmitDate': '2012-04-26', 'studyFirstSubmitQcDate': '2007-10-05', 'dispFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-04-26', 'studyFirstPostDateStruct': {'date': '2007-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Haemagglutination Inhibition (HI) Antibody Titers', 'timeFrame': 'At Day 21', 'description': 'Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.'}], 'secondaryOutcomes': [{'measure': 'HI Antibody Titers at Day 0 and Day 21', 'timeFrame': 'At Day 0 and 21', 'description': 'Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.'}, {'measure': 'HI Antibody Titers at Day 180', 'timeFrame': 'At Day 180', 'description': 'Antibody titers were expressed as GMTs in all the vaccine groups. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.'}, {'measure': 'The Number of Subjects Seroconverted to HI Antibodies at Day 21', 'timeFrame': 'At Day 21', 'description': 'A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.'}, {'measure': 'The Number of Subjects Seroconverted to HI Antibodies at Day 180', 'timeFrame': 'At Day 180', 'description': 'A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.'}, {'measure': 'HI Antibody Seroconversion Factors at Day 21', 'timeFrame': 'At Day 21', 'description': 'Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.'}, {'measure': 'HI Antibody Seroconversion Factors at Day 180', 'timeFrame': 'At Day 180', 'description': 'Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.'}, {'measure': 'The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21', 'timeFrame': 'At Day 0 and 21', 'description': 'A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.'}, {'measure': 'The Number of Subjects Seroprotected to HI Antibodies at Day 180', 'timeFrame': 'At Day 180', 'description': 'A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.'}, {'measure': 'The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21', 'timeFrame': 'At Days 0 and 21', 'description': 'The markers assessed were Cluster of Differentiation 4-All doubles i.e. CD4-All doubles, CD4-CD40Ligand(L), CD4-interferon gamma (CD4-IFNγ), CD4-interleukin 2 (CD4-IL2) and CD4-tumor necrosis factor alpha (CD4-TNFα). The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.'}, {'measure': 'The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180', 'timeFrame': 'At Day 180', 'description': 'The markers assessed were CD4-All doubles, CD4-CD40L, CD4-IFNγ, CD4-IL2 and CD4-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.'}, {'measure': 'The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21', 'timeFrame': 'At Days 0 and 21', 'description': 'The markers assessed were Cluster of Differentiation 8-All doubles i.e. CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.'}, {'measure': 'The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180', 'timeFrame': 'At Day 180', 'description': 'The markers assessed were CD8-All doubles, CD8-CD40L, CD8-IFNγ, CD8-IL2 and CD8-TNFα. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.'}, {'measure': 'Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)', 'timeFrame': 'During a 7-day follow-up period (Day 0-6) after vaccination', 'description': 'Grade 3 ecchymosis, pain, redness and swelling was greater than 100 millimeter (mm) i.e. \\> 100 mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities. Any was occurrence of any local symptom regardless of their intensity grade. Any for ecchymosis, redness and swelling was \\>20mm.'}, {'measure': 'Duration of Solicited Local AEs', 'timeFrame': 'During a 7-day follow-up period (Day 0-6) after vaccination', 'description': 'Duration was defined as number of days with any grade of local symptoms.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs', 'timeFrame': 'During a 7-day follow-up period (Day 0-6) after vaccination', 'description': 'Any Fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e.≥ 38.0°C, grade 3 fever was axillary temperature \\>40°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.'}, {'measure': 'Duration of Solicited General AEs', 'timeFrame': 'During a 7-day follow-up period (Day 0-6) after vaccination', 'description': 'Duration was defined as number of days with any grade of general symptoms.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs', 'timeFrame': 'During a 21-day follow-up period (Day 0-20) after vaccination', 'description': 'Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20', 'timeFrame': 'Between Day 0 and Day 20 after vaccination', 'description': 'For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.'}, {'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179', 'timeFrame': 'Between Day 21 and Day 179 after vaccination', 'description': 'For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a symptom that prevented normal activity. Related was a symptom assessed by the investigator as causally related to the study vaccination.'}, {'measure': 'Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20', 'timeFrame': 'Between Day 0 and Day 20 after vaccination', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.'}, {'measure': 'Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179', 'timeFrame': 'Between Day 21 and Day 179 after vaccination', 'description': 'SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.'}]}, 'conditionsModule': {'keywords': ['Influenza vaccine GSK576389A', 'Influenza infection', 'Fluarix'], 'conditions': ['Influenza']}, 'referencesModule': {'availIpds': [{'id': '110847', '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': '110847', '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': '110847', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110847', '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': '110847', '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': '110847', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110847', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '23890405', 'type': 'DERIVED', 'citation': 'Rumke HC, Richardus JH, Rombo L, Pauksens K, Plassmann G, Durand C, Devaster JM, Dewe W, Oostvogels L. Selection of an adjuvant for seasonal influenza vaccine in elderly people: modelling immunogenicity from a randomized trial. BMC Infect Dis. 2013 Jul 26;13:348. doi: 10.1186/1471-2334-13-348.'}], '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': "In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 65 years and older compared to Fluarix.", 'detailedDescription': 'There are 10 parallel groups: 9 observer blinded groups with subjects 65 years and older receiving an investigational vaccine or Fluarix, and 1 open group with subjects between 18 and 40 years old receiving Fluarix. CMI response will be determined for a subset only.\n\nThe Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.\n* A male or female aged 18-40 years old or 65 years or older at the time of the vaccination.\n* Written informed consent obtained from the subject.\n* Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.\n* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.\n* Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.\n* Planned administration of a vaccine not foreseen by the study protocol during the entire study period.\n* Planned administration of an influenza vaccine other than the study vaccines during the entire study period.\n* Vaccination against influenza since January 2007 (with 2007/2008 or 2006/2007 influenza vaccine).\n* Administration of more than 14 days of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination\n* Hypersensitivity to a previous dose of influenza vaccine.\n* Allergy to any component of the vaccine.\n* Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.\n* Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature\\<37.5ºC (99.5ºF).\n* Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.\n* Any medical conditions in which IM injections are contraindicated.\n* Lactating female or female planning to become pregnant or to discontinue contraceptive precautions'}, 'identificationModule': {'nctId': 'NCT00540592', 'briefTitle': "Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Observer Blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A With Various Formulations in Adults Aged 65 Years and Above", 'orgStudyIdInfo': {'id': '110847'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Influenza vaccine GSK576389A formulation 1 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.', 'interventionNames': ["Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A"]}, {'type': 'EXPERIMENTAL', 'label': 'Influenza vaccine GSK576389A formulation 2 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.', 'interventionNames': ["Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A"]}, {'type': 'EXPERIMENTAL', 'label': 'Influenza vaccine GSK576389A formulation 3 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.', 'interventionNames': ["Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A"]}, {'type': 'EXPERIMENTAL', 'label': 'Influenza vaccine GSK576389A formulation 4 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.', 'interventionNames': ["Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A"]}, {'type': 'EXPERIMENTAL', 'label': 'Influenza vaccine GSK576389A formulation 5 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.', 'interventionNames': ["Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A"]}, {'type': 'EXPERIMENTAL', 'label': 'Influenza vaccine GSK576389A formulation 6 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.', 'interventionNames': ["Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A"]}, {'type': 'EXPERIMENTAL', 'label': 'Influenza vaccine GSK576389A formulation 7 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.', 'interventionNames': ["Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A"]}, {'type': 'EXPERIMENTAL', 'label': 'Influenza vaccine GSK576389A formulation 8 Group', 'description': 'Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.', 'interventionNames': ["Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluarix elderly Group', 'description': 'Subjects aged ≥65 years received one dose of Fluarix vaccine.', 'interventionNames': ['Biological: Fluarix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluarix young Group', 'description': 'Subjects aged 18-40 years received one dose of Fluarix vaccine.', 'interventionNames': ['Biological: Fluarix']}], 'interventions': [{'name': "GlaxoSmithKline Biologicals' influenza vaccine GSK576389A", 'type': 'BIOLOGICAL', 'description': 'Single dose, Intramuscular injection, 8 different formulations were tested (one per group)', 'armGroupLabels': ['Influenza vaccine GSK576389A formulation 1 Group', 'Influenza vaccine GSK576389A formulation 2 Group', 'Influenza vaccine GSK576389A formulation 3 Group', 'Influenza vaccine GSK576389A formulation 4 Group', 'Influenza vaccine GSK576389A formulation 5 Group', 'Influenza vaccine GSK576389A formulation 6 Group', 'Influenza vaccine GSK576389A formulation 7 Group', 'Influenza vaccine GSK576389A formulation 8 Group']}, {'name': 'Fluarix', 'type': 'BIOLOGICAL', 'description': 'Single dose, Intramuscular injection', 'armGroupLabels': ['Fluarix elderly Group', 'Fluarix young Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74363', 'city': 'Güglingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.06642, 'lon': 9.00175}}, {'zip': '68161', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '73635', 'city': 'Rudersberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.88515, 'lon': 9.52927}}, {'zip': '69469', 'city': 'Weinheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.54887, 'lon': 8.66697}}, {'zip': '86150', 'city': 'Augsburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '51069', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45359', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '55624', 'city': 'Rhaunen', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.8638, 'lon': 7.34198}}, {'zip': '01067', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '01705', 'city': 'Freital', 'state': 'Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.00166, 'lon': 13.6488}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '39112', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'country': 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