Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT01231620
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2010-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Pakistan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053243', 'term': 'Zanamivir'}, {'id': 'D053139', 'term': 'Oseltamivir'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012794', 'term': 'Sialic Acids'}, {'id': 'D009438', 'term': 'Neuraminic Acids'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000606', 'term': 'Amino Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, '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': 'From the start of study drug until follow-up (up to 42 days).', 'description': 'Safety population was used to assess adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Intravenous (IV) Zanamivir 300mg Twice Daily', 'description': '300mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily', 'otherNumAtRisk': 201, 'deathsNumAtRisk': 201, 'otherNumAffected': 17, 'seriousNumAtRisk': 201, 'deathsNumAffected': 15, 'seriousNumAffected': 38}, {'id': 'EG001', 'title': 'Intravenous (IV) Zanamivir 600mg Twice Daily', 'description': '600mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily', 'otherNumAtRisk': 209, 'deathsNumAtRisk': 209, 'otherNumAffected': 26, 'seriousNumAtRisk': 209, 'deathsNumAffected': 15, 'seriousNumAffected': 33}, {'id': 'EG002', 'title': 'Oral Oseltamivir 75mg Twice Daily', 'description': '75mg oral oseltamivir twice daily plus intravenous placebo zanamivir twice daily', 'otherNumAtRisk': 205, 'deathsNumAtRisk': 205, 'otherNumAffected': 24, 'seriousNumAtRisk': 205, 'deathsNumAffected': 11, 'seriousNumAffected': 38}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Distributive shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Mechanical ventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Anti-neutrophil cytoplasmic antibody', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Delirium febrile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Endotracheal intubation complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tracheostomy malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'ECG signs of ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chronic obstructive pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory disorderv', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Disseminated intravascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intraventricular haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neuromyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'IgA nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia necrotising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vestibular neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Clinical Response (TTCR) in Participants With Confirmed Influenza', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.87', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '99.90'}, {'value': '5.14', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '99.90'}, {'value': '5.63', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '99.90'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.73', 'ciLowerLimit': '-1.79', 'ciUpperLimit': '0.75', 'estimateComment': 'IV Zanamivir 300 mg versus IV Zanamivir 600 mg', 'statisticalMethod': 'Wilcoxon rank sum', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.39', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-2.11', 'ciUpperLimit': '0.97', 'estimateComment': 'Oral oseltamivir 75 mg versus IV Zanamivir 600 mg', 'statisticalMethod': 'Wilcoxon rank sum', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 42 days', 'description': 'Clinical response is defined as the resolution of at least 4 of the 5 vital signs (temperature, oxygen saturation, respiratory status, heart rate, systolic blood pressure) within the respective resolution criteria, maintained for at least 24 hours, or hospital discharge, whichever occurred first. This analysis was performed for Influenza positive population, for those with symptom onset less than or equal to (\\<=) 4 days, and for those on mechanical (mech) ventilation or in intensive care unit (ICU). 99 days is censored time for the participants who did not achieve TTCR.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E population comprised of all randomized participants who received at least one dose of investigational product. The Influenza positive population (IPP) is comprised of all participants in the ITT-E population with proven influenza infection.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Respiratory Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.506', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wei-Johnson method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.41', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Wei-Johnson method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days', 'description': 'Respiratory Status (RS) is a component of TTCR. Response criteria included the return to the pre-morbid oxygen requirement (participants with chronic oxygen use), a need for supplemental oxygen (administered by any modality: ventilator, non-invasive ventilation, facemask, facetent, nasal canula, etc.) to no need for supplemental oxygen, or a respiratory rate of =\\<24 breaths/minute (without supplemental oxygen). Data are presented as the percentage of participants achieving respiratory improvement.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All Cause and Attributable Mortality at Day 14, at Day 28, and at the End of Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Died on or before Study Day 14: all cause', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Died on or before Study Day 28: all cause', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Died while on-study: all cause', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Died on or before Study Day 14: attributable', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Died on or before Study Day 28: attributable', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Died while on-study: attributable', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On or before Day 14, Day 28, End of Study Visit (assessed up to 42 days)', 'description': 'The number of participants who died on or before Day 14, Day 28, and the End of Study Visit were summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Katz Activities of Daily Living (ADL) Score and Each ADL Activity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Total Score Day 5/6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.07', 'spread': '1.959', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '1.782', 'groupId': 'OG001'}, {'value': '0.78', 'spread': '1.837', 'groupId': 'OG002'}]}]}, {'title': 'Total Score Day 10/11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '1.746', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.837', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '3.029', 'groupId': 'OG002'}]}]}, {'title': 'Total Score Last Day of S/R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '4.243', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '1.165', 'groupId': 'OG002'}]}]}, {'title': 'Total Score PT+28 Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.13', 'spread': '2.234', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '2.342', 'groupId': 'OG001'}, {'value': '1.98', 'spread': '2.142', 'groupId': 'OG002'}]}]}, {'title': 'Bathing: DAY 5/6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.488', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.429', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.438', 'groupId': 'OG002'}]}]}, {'title': 'Bathing: DAY 10/11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.403', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.426', 'groupId': 'OG002'}]}]}, {'title': 'Bathing: Last Day of S/R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.447', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.707', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Bathing: PT + 28 DAYS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.498', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.505', 'groupId': 'OG001'}, {'value': '0.39', 'spread': '0.507', 'groupId': 'OG002'}]}]}, {'title': 'Dressing DAY 5/6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.481', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.438', 'groupId': 'OG001'}, {'value': '0.14', 'spread': '0.427', 'groupId': 'OG002'}]}]}, {'title': 'Dressing: Day 10/11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.342', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.515', 'groupId': 'OG002'}]}]}, {'title': 'Dressing: Last Day of S/R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.447', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.707', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.354', 'groupId': 'OG002'}]}]}, {'title': 'Dressing:PT+28 Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.495', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.515', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.494', 'groupId': 'OG002'}]}]}, {'title': 'Toileting: DAY 5/6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.456', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.439', 'groupId': 'OG001'}, {'value': '0.14', 'spread': '0.409', 'groupId': 'OG002'}]}]}, {'title': 'Toileting: Day 10/11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.342', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.516', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.515', 'groupId': 'OG002'}]}]}, {'title': 'Toileting: Last Day of S/R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.447', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.707', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.535', 'groupId': 'OG002'}]}]}, {'title': 'Toileting: PT+28 Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.491', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.514', 'groupId': 'OG001'}, {'value': '0.37', 'spread': '0.484', 'groupId': 'OG002'}]}]}, {'title': 'Transferring: DAY 5/6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.505', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.451', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.41', 'groupId': 'OG002'}]}]}, {'title': 'Transferring: Day 10/11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.403', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.408', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.515', 'groupId': 'OG002'}]}]}, {'title': 'Transferring: Last Day of S/R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.707', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.707', 'groupId': 'OG001'}, {'value': '0.25', 'spread': '0.463', 'groupId': 'OG002'}]}]}, {'title': 'Transferring: PT+28 Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.499', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.526', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.492', 'groupId': 'OG002'}]}]}, {'title': 'Continence: DAY 5/6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.322', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.314', 'groupId': 'OG001'}, {'value': '0.07', 'spread': '0.374', 'groupId': 'OG002'}]}]}, {'title': 'Continence: Day 10/11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.342', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.669', 'groupId': 'OG002'}]}]}, {'title': 'Continence: Last Day of S/R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.447', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.707', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '0.354', 'groupId': 'OG002'}]}]}, {'title': 'Continence: PT+28 Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.431', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.422', 'groupId': 'OG001'}, {'value': '0.23', 'spread': '0.439', 'groupId': 'OG002'}]}]}, {'title': 'Feeding: Day 5/6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.331', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.309', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.382', 'groupId': 'OG002'}]}]}, {'title': 'Feeding: Day 10/11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.342', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.669', 'groupId': 'OG002'}]}]}, {'title': 'Feeding: Last Day of S/R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.447', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.707', 'groupId': 'OG001'}, {'value': '0.25', 'spread': '0.463', 'groupId': 'OG002'}]}]}, {'title': 'Feeding: PT+28 Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.409', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.416', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.395', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'The Katz ADL scores were collected for bathing, dressing, toileting, transferring, continence, and feeding activities and were assessed once daily during the treatment period/hospitalization and once at each post-treatment Clinic Visit. For the six individual activities, a score of 1 indicates independence, and a score of 0 indicates dependence. The total score is generated by adding the scores of all six activities. A total score of 6 indicates that the participant was independent; a total score of 0 indicates that the participant was very dependent. Baseline is defined as the pre-dose value collected on Study Day 1. Change from Baseline is defined as the difference at each time point (Day 5/6, and Day 10/11, and last day S/R if treatment was extended beyond 5 days) and the end of the study (post-treatment \\[PT\\] +28 Days) compared to Baseline.', 'unitOfMeasure': 'Scores on the scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Median Time to Return to Pre-morbid Functional Status as Measured by the Katz ADL Score and Each ADL Activity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Total score', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '38'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '37'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '57'}]}]}, {'title': 'Bathing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '38'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '37'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '57'}]}]}, {'title': 'Dressing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '38'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '40'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '57'}]}]}, {'title': 'Toileting', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '38'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '31'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '40'}]}]}, {'title': 'Transferring', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '38'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '31'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '40'}]}]}, {'title': 'Continence', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '35'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '33'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '31'}]}]}, {'title': 'Feeding', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '29'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '32'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 42 days', 'description': 'Pre-morbid functional status is defined as the best functional status in the 4 weeks prior to enrolment. Median time to return to pre-morbid functional status was assessed via the Katz ADL score (bathing, dressing, toileting, transferring, continence, and feeding activities). For the six individual activities, a score of 1 indicates independence, and a score of 0 indicates dependence. The total score is generated by adding the scores of all six activities. A total score of 6 indicates that the participant was independent; a total score of 0 indicates that the participant was very dependent.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Returned to Their Pre-morbid Functional Status as Assessed Per the Katz ADL Score and Each ADL Activity Score at the End of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Total', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}]}, {'title': 'Bathing', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}]}, {'title': 'Dressing', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}]}, {'title': 'Toileting', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}]}, {'title': 'Transferring', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}]}, {'title': 'Continence', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '139', 'groupId': 'OG002'}]}]}, {'title': 'Feeding', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 42 days', 'description': 'Pre-morbid functional status is defined as the best functional status in the 4 weeks prior to enrolment. The number of participants who returned to their pre-morbid functional status at the end of the study assessed per the Katz ADL score (bathing, dressing, toileting, transferring, continence and feeding activities) is summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population'}, {'type': 'SECONDARY', 'title': 'Median Time to Return to the Pre-morbid Level of Activity as Measured by the 3-point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '34'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '31'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 42 days', 'description': 'Median time to return to pre-morbid level of activity was assessed once daily during treatment/hospitalization and once at each post-treatment assessment and was measured using the 3- point scale (bed rest, limited ambulation, or unrestricted).', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population. Participants succeeded in pre-morbid functional status were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Clinical Symptoms of Influenza', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Anorexia', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}]}, {'title': 'Dyspnea', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}]}, {'title': 'Feverishness', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}]}, {'title': 'Myalgias', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}]}, {'title': 'Nasal symptoms (rhinorrhea, congestion)', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}, {'title': 'Sore throat', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 42 days', 'description': 'Influenza clinical symptoms included nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea, and vomiting. Influenza symptoms were assessed once daily during inpatient hospitalization and once at each post-treatment assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population'}, {'type': 'SECONDARY', 'title': 'Median Time of Duration of Clinical Symptoms of Influenza', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Anorexia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '39'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '46'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '55'}]}]}, {'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '39'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '46'}, {'value': '15', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '56'}]}]}, {'title': 'Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '29'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '28'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '23'}]}]}, {'title': 'Dyspnea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '40'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '43'}, {'value': '8', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '56'}]}]}, {'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '41'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '44'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '56'}]}]}, {'title': 'Feverishness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '28'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '29'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '56'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '33'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '33'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '56'}]}]}, {'title': 'Myalgias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '39'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '34'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '56'}]}]}, {'title': 'Nasal symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '34'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '43'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '35'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '34'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '24'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '28'}]}]}, {'title': 'Sore throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '28'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '36'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '35'}]}]}, {'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '19'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 42 days', 'description': 'Influenza clinical symptoms included nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea, and vomiting. Influenza symptoms were assessed once daily during inpatient/hospitalization and once at each post-treatment assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complications of Influenza and Associated Antibiotic Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Associated use of any antibiotic', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Any complication of influenza', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 42 days', 'description': 'The number of participants with complications of influenza and associated antibiotic use were summarized', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Ventilation Status: Modality of Invasive and Non-invasive Ventilator Support and Oxygen Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Day 1, Machine-Assisted: ECMO', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Day 1, Machine-Assisted: Endotracheal', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Day 1, SOD', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}, {'title': 'Day 1, No supplemental O2 or ventilation support', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Day 1, Respiratory Support', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'AT on Study, Machine-Assisted: ECMO', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'AT on Study, Machine-Assisted: Endotracheal', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'AT on Study, SOD', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}]}, {'title': 'AT on Study, No supplemental O2 or ventilation sup', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}]}, {'title': 'AT on Study, Respiratory Support', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 42 days', 'description': 'Ventilation status was assessed three times daily during the treatment period/hospitalization. Ventilation status was assessed once daily during inpatient/hospitization and once at each post-treatment clinic visit. The number of participants reported for machine-assisted: extracorporeal membrane oxygenation (ECMO), endotracheal mechanical ventilation, and supplemental oxygen delivery (SOD), no supplemental oxygen (O2) or ventilation support, Respiratory support at "any time (AT) on study" and at Baseline (Day 1) are summarized. Data for the "any time (AT) on study" time point was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population'}, {'type': 'SECONDARY', 'title': 'Median Time of Duration of Invasive and Non-invasive Ventilator Support and Oxygen Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Ventilator Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '38'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '36'}, {'value': '8.2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '36'}]}]}, {'title': 'Oxygen Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '38'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '43'}, {'value': '3.7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Ventilation status was assessed three times daily during the treatment period/hospitalization. Ventilation status was assessed once daily during inpatient/hospitalization and once at each post-treatment clinic visit.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population. Only those participants available with the indicated ventilator support or oxygen supplementation were analyzed.'}, {'type': 'SECONDARY', 'title': 'Median Time of Duration of Hospitalization and Intensive Care Unit (ICU) Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '108'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '64'}, {'value': '9', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '58'}]}]}, {'title': 'Hospitalization while on study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '39'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '43'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '39'}]}]}, {'title': 'Hospitalization-ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '41'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '36'}, {'value': '8', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '36'}]}]}, {'title': 'ICU Duration Modified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '39'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '36'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to the end of the study (assessed up to 42 days)', 'description': 'Hospital duration and ICU duration was assessed from the first day of dosing. Hospital duration was calculated as the discharge date minus the admission date + 1. Hospital duration while on study was the earlier of discharge, completion, or withdrawal minus the later of the admission date or the study start date + 1. ICU duration-Modified was calculated as the original ICU duration minus ICU days prior to Study Day 1.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Median Time to the Absence of Fever and Improved Respiratory Status, Oxygen Saturation, Heart Rate, and Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '34'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '31'}]}]}, {'title': 'Oxygen Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '32'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '25'}]}]}, {'title': 'Respiratory status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '31'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '32'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '21'}]}]}, {'title': 'Heart rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '21'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '24'}]}]}, {'title': 'Systolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '23'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'The absence of fever is defined as a non-axillary temperature recording \\<=36.6 degrees Celsius axillary, \\<= 37.2 degrees Celsius oral or \\<= 37.7 degrees Celsius core. Respiratory Status (RS) response criteria included the return to the pre-morbid oxygen requirement (participants with chronic oxygen use), or the need for supplemental oxygen (administered by any modality: ventilator, non-invasive ventilation, facemask, facetent, nasal canula, etc.) to no need for supplemental oxygen, or a respiratory rate =\\<24 breaths/minute (without supplemental oxygen). Oxygen saturation response criteria: \\>=95% (without supplemental oxygen). Heart rate response criteria: =\\<100 beats/minute. Systolic blood pressure response criteria: \\>=90 millimeters of mercury. Vital signs were assessed three times daily during the treatment period/hospitalization. Vital signs were assessed once daily during inpatient/hospitization and once at each post-treatment clinic visit.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population'}, {'type': 'SECONDARY', 'title': 'Median Time to Virologic Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Influenza A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '34'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '35'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '34'}]}]}, {'title': 'Influenza A/H1N1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '13'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '34'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '34'}]}]}, {'title': 'Influenza A/H3N2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '35'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '11'}]}]}, {'title': 'Influenza B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '34'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '21'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Virologic improvement is defined as a 2 log drop in viral load or sustained undetectable viral ribonucleic acid (RNA) (on two successive occasions) as measured by quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) from nasopharyngeal samples. Nasopharyngeal swabs were collected daily from Baseline through Day 5. If randomized treatment was continued beyond Day 5, samples were taken on Treatment Days 6, 8, 10 and on the last day of randomized treatment. For participants who utilized the Switch (S)/Rescue (R) option, samples were taken on S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6, whichever was the last day of S/R treatment. Nasopharyngeal swabs were taken if the participant was symptomatic and continued to be hospitalized on the Post-Treatment +2, +5, +9, +16, and +28 day assessment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population. Only those participants available at the specified time points were analyzed. Data presented is for participants positive at Baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quantitative Virus Culture From Nasopharyngeal Swabs Positive at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.01', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '0.8'}, {'value': '-2.01', 'groupId': 'OG001', 'lowerLimit': '-4.8', 'upperLimit': '1.3'}, {'value': '-2.01', 'groupId': 'OG002', 'lowerLimit': '-5.3', 'upperLimit': '2.8'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.51', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '0.0'}, {'value': '-2.26', 'groupId': 'OG001', 'lowerLimit': '-5.3', 'upperLimit': '0.0'}, {'value': '-2.26', 'groupId': 'OG002', 'lowerLimit': '-5.3', 'upperLimit': '2.0'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.64', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '0.0'}, {'value': '-2.01', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '-0.3'}, {'value': '-2.26', 'groupId': 'OG002', 'lowerLimit': '-4.3', 'upperLimit': '0.0'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.76', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '-0.3'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '-0.3'}, {'value': '-2.26', 'groupId': 'OG002', 'lowerLimit': '-3.8', 'upperLimit': '-1.3'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.01', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '-0.3'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '-0.3'}, {'value': '-2.26', 'groupId': 'OG002', 'lowerLimit': '-3.8', 'upperLimit': '-1.3'}]}]}, {'title': 'S/R Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '-4.3'}, {'value': '-3.0', 'groupId': 'OG002', 'lowerLimit': '-3.0', 'upperLimit': '-3.0'}]}]}, {'title': 'S/R Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-2.5', 'upperLimit': '-2.5'}, {'value': '-4.3', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '-4.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1), Day 3, Day 5, Day 8, Day 10, Day 11 and/or last day of randomized treatment, if randomized treatment was extended beyond 5 days, and S/R Day 5/6 (up to Day 14) if applicable', 'description': 'Nasopharyngeal swabs were collected daily from Baseline through Day 5. If randomized treatment was continued beyond Day 5, samples were taken on Treatment Day 6, Day 8, Day 10, Day 11, and the last day of randomized treatment. For participants who utilized the S/R option, samples were taken on S/R Day1, S/R Day3, S/R Day5, or S/R Day6, whichever was the last day of S/R treatment. Samples were taken if the participant was symptomatic and continued to be hospitalized on the Post-Treatment +2, +5, +9, +16 and +28Day assessment. Viral load was measured by Quantitative Virus Culture, log10 50% Tissue Culture Infectious Dose (TCID50)/milliliter (mL). Baseline is defined as the pre-dose value collected on Study Day 1. Change from Baseline was calculated as the post-Baseline value minus Baseline value .', 'unitOfMeasure': 'log10 TCID50/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Viral Load (Influenza A or B) by qPCR From Nasopharyngeal Swabs Positive at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-5.4', 'upperLimit': '2.2'}, {'value': '-1.83', 'groupId': 'OG001', 'lowerLimit': '-4.9', 'upperLimit': '2.0'}, {'value': '-1.75', 'groupId': 'OG002', 'lowerLimit': '-6.0', 'upperLimit': '2.8'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.51', 'groupId': 'OG000', 'lowerLimit': '-5.8', 'upperLimit': '3.2'}, {'value': '-2.71', 'groupId': 'OG001', 'lowerLimit': '-6.2', 'upperLimit': '3.1'}, {'value': '-2.73', 'groupId': 'OG002', 'lowerLimit': '-6.3', 'upperLimit': '2.3'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.38', 'groupId': 'OG000', 'lowerLimit': '-4.4', 'upperLimit': '1.0'}, {'value': '-3.16', 'groupId': 'OG001', 'lowerLimit': '-5.5', 'upperLimit': '-0.3'}, {'value': '-1.78', 'groupId': 'OG002', 'lowerLimit': '-5.7', 'upperLimit': '1.1'}]}]}, {'title': 'Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.75', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '-0.9'}, {'value': '-3.03', 'groupId': 'OG001', 'lowerLimit': '-3.5', 'upperLimit': '1.5'}, {'value': '-2.63', 'groupId': 'OG002', 'lowerLimit': '-4.6', 'upperLimit': '0.9'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.58', 'groupId': 'OG000', 'lowerLimit': '-4.9', 'upperLimit': '-0.6'}, {'value': '-2.6', 'groupId': 'OG001', 'lowerLimit': '-3.1', 'upperLimit': '1.7'}, {'value': '-3.29', 'groupId': 'OG002', 'lowerLimit': '-4.9', 'upperLimit': '-1.0'}]}]}, {'title': 'S/R Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'groupId': 'OG001', 'lowerLimit': '-3.8', 'upperLimit': '-3.8'}, {'value': '-5.7', 'groupId': 'OG002', 'lowerLimit': '-5.7', 'upperLimit': '-5.7'}]}]}, {'title': 'S/R Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'groupId': 'OG000', 'lowerLimit': '-5.2', 'upperLimit': '-5.2'}, {'value': '-5.4', 'groupId': 'OG001', 'lowerLimit': '-5.4', 'upperLimit': '-5.4'}, {'value': '-3.84', 'groupId': 'OG002', 'lowerLimit': '-4.0', 'upperLimit': '-3.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1), Day 3, Day 5, Day 8, Day 10, Day 11 and/or last day of randomized treatment, if randomized treatment was extended beyond 5 days, and S/R Day 5/6 (up to Day 14) if applicable', 'description': 'Nasopharyngeal swabs were collected daily from Baseline through Day 5. If randomized treatment was continued beyond Day 5, samples were taken on Treatment Day 6, Day 8, Day 10, Day 11, and the last day of randomized treatment. For participants who utilized the S/R option, samples were taken on S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6, whichever was the last day of S/R treatment. Samples were taken if the participant was symptomatic and continued to be hospitalized on the post-treatment +2, +5, +9, +16 and +28 day assessment. Viral load as measured by PCR. Baseline is defined as the pre-dose value collected on Study Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.', 'unitOfMeasure': 'log10 vp/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With no Detectable Viral RNA and the Absence of Cultivable Virus in Lower Respiratory Samples (Bronchoalveolar Lavage Sample [BAL], Endotracheal Aspirate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Influenza A and B Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B S/R Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B S/R Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B S/R Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Influenza A and B PT + 2 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B PT + 5 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B PT + 9 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B PT + 16 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Influenza A and B PT + 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Lower respiratory samples included BAL and endotracheal aspirates. Endotracheal aspirates were requested in participants (par.) who were intubated. Upper (nasopharyngeal swabs) and lower (Endotracheal aspirates, bronchoalveolar lavage samples) respiratory samples were collected daily from Baseline/Day 1 through Day 5 and Day 6 (if the last day of randomized treatment \\[trt\\]). Endotracheal aspirates were collected in participants who were intubated. If trt was continued beyond Day 5, additional samples were taken on Trt Day 6, Day 8, Day 10, and/or the day of the last dose of randomized trt, if applicable, and S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6 if the last day of S/R trt. If the par. was symptomatic and hospitalized, samples were taken on the Post-Trt +2, +5, +9, +16 assessment days, and at the Post-Trt \\[PT\\]+28 Day assessment. Assessment of samples was done by quantitative RT-PCR and viral culture.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population. Data is presented for participants positive at Baseline. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Median Time to no Detectable Viral RNA and the Absence of Cultivable Virus in Any Obtained Sample (Upper and Lower Respiratory Samples)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Influenza A and B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '34'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '35'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '57'}]}]}, {'title': 'Positive at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '34'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '35'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Upper (nasopharyngeal swabs) and lower (Endotracheal aspirates, bronchoalveolar lavage samples, where available) respiratory samples were collected daily from Baseline/Day 1 through Day 5 and Day 6 (if the last day of randomized treatment). Endotracheal aspirates were collected in participants who were intubated. If treatment was continued beyond Day 5, additional samples were taken on Treatment Day 6, Day 8, Day 10, and/or the day of the last dose of randomized treatment, if applicable, and S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6 if the last day of S/R treatment. If the participant was symptomatic and hospitalized, samples were taken on the Post-treatment+2, +5, +9, +16 assessment days, and at the Post-Treatment +28 Day. Assessment of samples was done by quantitative RT-PCR.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population. Only those participants available at the specified time points were analyzed. Data also presented for participants positive at Baseline.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Resistance-associated Mutations Detected in the Neuraminidase (NA) and Hemagglutinin (HA) Gene of Influenza A and B Viruses in Nasopharyngeal Swabs and Endotracheal/BAL Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'NA Gene,H3N2: Y155F', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H3N2:S245N', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H3N2:I222V', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H3N2:N294S/N', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H3N2:V149A', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H3N2:D198D/G', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H3N2:G248G/E', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H3N2:N294D/N', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H3N2:R292R/K', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H3N2:T325I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H3N2:Y155H', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H1N1: H275H/Y', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H1N1:H275Y', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H1N1:Q313R', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H1N1:D199N', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H1N1:E278G/E', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H1N1:I223I/K', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H1N1:Q136Q/R', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H1N1:S247N', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H1N1:S247S/I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,H1N1:S247S/N', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,B: E148G', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,B: G141E', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'NA Gene,B: M403I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H3N2:R142G', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H3N2:S198A', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H3N2:A138S', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H3N2:R142K', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H3N2:A304A/P', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H3N2:A304D', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H3N2:L194P/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H3N2:Q75H', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H3N2:S124G', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H3N2:S262N', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H3N2:H1N1: S183P', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H1N1 :D222D/G', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H1N1 :D222D/N', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H1N1 :D222N', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H1N1 :S162N', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H1N1 :D187E', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H1N1 :D222G', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H1N1 :D222S/D/N/G', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H1N1 :L151P/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HA Gene, H1N1 :V152I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Nasopharyngeal swabs and endotracheal /BAL samples were collected for viral susceptibility analysis. Susceptibility analyses consisted of phenotyping and genotyping. Resistance mutations were detected by genotyping. Viral susceptibility to zanamivir and oral oseltamivir at Baseline and throughout treatment determined by NA and HA (gene of influenza A and B viruses) sequence analysis and NA enzyme inhibition. Number of participants with viral mutation events are summarized, this includes all resistance mutations (substitutions) i.e. those present at Baseline and those that emerged during treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'IPP Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 42 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. All AEs were assessed by the Investigator as related or not related to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population comprised of all randomized participants who received at least one dose of investigational product and assessed according to their actual treatment received, regardless of the randomization assigned.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Severe or Grade 3/4 AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 42 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. AEs that occurred during the study were evaluated by the Investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of AEs. Grade 3=severe; Grade 4=potentially life threatening.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 42 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were Permanently Discontinued From the Study Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 42 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Severe or Grade 3/4 Treatment-related AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 42 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. AEs that occurred during the study were evaluated by the Investigator and graded according to the DAIDS table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening. All AEs were assessed by the Investigator as related or not related to the study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Chemistry Laboratory Values Shifts From Baseline (Day 1) and up to 42 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Albumin G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Albumin G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Albumin G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Albumin G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALP G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'ALP G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ALP G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALP G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'ALT G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ALT G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALT G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'AST G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'AST G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'AST G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'AST G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Total Bilirubin G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Total Bilirubin G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Total Bilirubin G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Total Bilirubin G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Creatine Kinase G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Creatine Kinase G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Creatine Kinase G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Creatine Kinase G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'CO2 G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'CO2 G2,', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'CO2 G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CO2 G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Magnesium G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Magnesium G2,', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Magnesium G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Magnesium G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Samples for laboratory assessments were collected at Baseline (Day 1), Day 3, Day 5/6, Day 8, Day 10/11 (or last day of randomized treatment), switch/rescue (S/R) Day 1, S/R Day 3, and S/R Day 5/6 (last day of S/R treatment for those participants who utilized this option), Post-Treatment +2 (if hospitalized), and Post-Treatment +5, +16, and +28 Days. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino tranferase (AST), total bilirubin, calcium, creatine kinase, chloride, carbon dioxide content (CO2), creatinine, potassium, magnesium, sodium. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade (G) 1=mild, G2= moderate, G3=severe and G4=potentially life threatening. The number of participants with values that were G1, G2, G3 and G4 relative to the normal range are summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only the participants available at the time of assessment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Hematology Values Shifts From Baseline (Day 1) and up to 42 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Hemoglobin G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Neutrophils G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Platelets G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Platelets G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Platelets G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Platelets G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes G1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes G2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Blood samples for laboratory assessments were collected at Baseline (Day 1), Day 3, Day 5/6, Day 8, Day 10/11 (or last day of randomized treatment), S/R Day 1, S/R Day 3, and S/R Day 5/6 (last day of S/R treatment for those participants who utilized this option), Post-Treatment +2 (if hospitalized), and Post-Treatment +5, +16, and +28 Days. Hematology parameters included hemoglobin, lymphocytes, total neutrophils, platelet count, and white blood cell (WBC) count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade (G) 1=mild, G2= moderate, G3=severe and G4=potentially life threatening. The number of participants with values that were G1, G2, G3 and G4 relative to the normal range for the indicated hematology parameters is summarized. Baseline is defined as the pre-dose value collected on Study Day 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only the participants available at the time of assessment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Treatment-emergent (TE) Grade (G) 3/4 Clinical Chemistry Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Albumin, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALP, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ALP, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ALT, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'ALT, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'AST, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'AST, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Total Bilirubin, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Total Bilirubin, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatine Kinase, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Creatine Kinase, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Carbon Dioxide, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Carbon Dioxide, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Magnesium, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Magnesium, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypercalcemia, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hyperkalemia, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Hypernatremia, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Hypocalcemia, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypokalemia, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hyponatremia G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatine kinase, chloride, CO2/bicarbonate, creatinine, potassium, magnesium and sodium. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the pre-dose value collected on Study Day 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Only the participants available at the time of assessment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Hemoglobin, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Lymphocytes, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Total Neutrophils, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Total Neutrophils, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes Count, G3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes Count, G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). The hematology parameters included hemoglobin, lymphocytes, total neutrophils, platelet count, and WBC count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the pre-dose value collected on Study Day 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only the participants available at the time of assessment were analyzed.'}, {'type': 'SECONDARY', 'title': 'Median Quantity of Oxygen Delivery Measured at Baseline (Day 1) and During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'timeFrame': 'Baseline (Day 1) and during the study', 'description': 'Oxygen delivery were assessed three times daily at Baseline (Day 1) and during the treatment period/hospitalization (ideally at least 6 hours apart) and once daily during inpatient/hospitalization and once at Post +5 days, +16 days, and +28 days clinic visits. The median quantity of oxygen delivery during the study was not summarized since the data was not collected in a way to accurately calculate values. Baseline is defined as the pre-dose value collected on Study Day 1.', 'reportingStatus': 'POSTED', 'populationDescription': 'This end point was not analyzed'}, {'type': 'SECONDARY', 'title': 'Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1) and Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'Normal', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal - Not Clinically Significant', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}]}, {'title': 'Abnormal - Clinically Significant', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) and Day 4', 'description': 'On Baseline/Day 1, a 12-lead ECG was obtained within approximately 24 hours prior to dosing. The number of participants with an ECG status of normal and abnormal CS or NCS, as determined by the Investigator, is reported. Normal=all ECG parameters within the accepted normal ranges. Abnormal=ECG findings outside of normal ranges. CS=ECG with a CS abnormality that meets exclusion criteria. NCS=ECG with an abnormality that is not CS nor meets exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. In the original protocol ECGs were also done on Day 4, however, amendment 2 removed this requirement and therefore not all participants had Day 4 ECGs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration of IV Zanamivir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'OG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'OG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'classes': [{'title': 'CL <15, Day 1, 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14454.6', 'spread': 'NA', 'comment': 'Data not collected', 'groupId': 'OG000'}, {'value': '26410.8', 'spread': '21335.43', 'groupId': 'OG001'}]}]}, {'title': 'CL <15, Day 4, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '293.2', 'spread': 'NA', 'comment': 'Data not collected', 'groupId': 'OG000'}, {'value': '9635.6', 'spread': '8270.67', 'groupId': 'OG001'}]}]}, {'title': 'CL <15, Day 4, 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1329.4', 'spread': 'NA', 'comment': 'Data not collected', 'groupId': 'OG000'}, {'value': '19828.9', 'spread': 'NA', 'comment': 'Data not available', 'groupId': 'OG001'}]}]}, {'title': 'CL <15, Day 4, 11-12 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '605.1', 'spread': 'NA', 'comment': 'Data not collected', 'groupId': 'OG000'}, {'value': '15459.1', 'spread': 'NA', 'comment': 'Data not available', 'groupId': 'OG001'}]}]}, {'title': 'CL 15-<30, Day 13, 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20403.3', 'spread': '11623.28', 'groupId': 'OG000'}, {'value': '41102.8', 'spread': '13884.08', 'groupId': 'OG001'}]}]}, {'title': 'CL 15-<30, Day 4, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5906.4', 'spread': '7167.87', 'groupId': 'OG000'}, {'value': '4995.6', 'spread': '1966.72', 'groupId': 'OG001'}]}]}, {'title': 'CL 15-<30, Day 4, 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13636.4', 'spread': '14029.44', 'groupId': 'OG000'}, {'value': '13378', 'spread': '2581.36', 'groupId': 'OG001'}]}]}, {'title': 'CL 15-<30, Day 4, 11-12 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7600.3', 'spread': '8061.65', 'groupId': 'OG000'}, {'value': '4953.4', 'spread': '2232.16', 'groupId': 'OG001'}]}]}, {'title': 'CL 30-<50, Day 1, 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18756.8', 'spread': '12806.43', 'groupId': 'OG000'}, {'value': '42467.3', 'spread': '14574.82', 'groupId': 'OG001'}]}]}, {'title': 'CL 30-<50, Day 4, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2094.8', 'spread': '1300.99', 'groupId': 'OG000'}, {'value': '7637.4', 'spread': '7212.1', 'groupId': 'OG001'}]}]}, {'title': 'CL 30-<50, Day 4, 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12334.4', 'spread': '12121.18', 'groupId': 'OG000'}, {'value': '159292.1', 'spread': '473267.3', 'groupId': 'OG001'}]}]}, {'title': 'CL 30-<50, Day 4, 11-12 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2932.5', 'spread': '2425.81', 'groupId': 'OG000'}, {'value': '19549.2', 'spread': '40577.76', 'groupId': 'OG001'}]}]}, {'title': 'CL 50-<80, Day 1, 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19146.7', 'spread': '8853.11', 'groupId': 'OG000'}, {'value': '49666.1', 'spread': '111785.9', 'groupId': 'OG001'}]}]}, {'title': 'CL 50-<80, Day 4, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2793.3', 'spread': '4694.43', 'groupId': 'OG000'}, {'value': '13107.7', 'spread': '33768.61', 'groupId': 'OG001'}]}]}, {'title': 'CL 50-<80, Day 4, 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31541.3', 'spread': '93381', 'groupId': 'OG000'}, {'value': '22220.4', 'spread': '10064.83', 'groupId': 'OG001'}]}]}, {'title': 'CL 50-<80, Day 4, 11-12 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1345.9', 'spread': '1122.18', 'groupId': 'OG000'}, {'value': '22623.9', 'spread': '57663.24', 'groupId': 'OG001'}]}]}, {'title': 'CL >=80, Day 1, 30 min,', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18561.7', 'spread': '10332.14', 'groupId': 'OG000'}, {'value': '35139.2', 'spread': '17693.85', 'groupId': 'OG001'}]}]}, {'title': 'CL >=80, Day 4, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2342.6', 'spread': '6672.12', 'groupId': 'OG000'}, {'value': '19379.8', 'spread': '105056.3', 'groupId': 'OG001'}]}]}, {'title': 'CL >=80, Day 4, 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21580.7', 'spread': '22062.69', 'groupId': 'OG000'}, {'value': '75255.1', 'spread': '167670.6', 'groupId': 'OG001'}]}]}, {'title': 'CL >=80, Day 4, 11-12 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2036.2', 'spread': '4412.75', 'groupId': 'OG000'}, {'value': '19428.7', 'spread': '142284.7', 'groupId': 'OG001'}]}]}, {'title': 'Missing, Day 1, 30 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41109.7', 'spread': '3831.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Day 4', 'description': 'Pharmacokinetic samples were collected at four time points to characterize peak concentration (end of infusion; C\\[EOI\\]) after the first dose on Day 1 and on Day 4 to characterize the pre-dose concentration (C\\[0\\]), the peak concentration C(EOI), and the trough concentration at 11-12 hours post-dose (C\\[12\\]) of zanamavir. Data was summarized by Creatinine clearance (CL) Category. The dose on Day 1 is the initial dose (unadjusted) and the dose on Day 4 is the maintenance dose.', 'unitOfMeasure': 'microgram/Liter (mcg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Population comprised of all participants who received IV zanamivir and underwent sparse PK sampling during the study from which one or more serum zanamivir concentrations was determined. This outcome was not analyzed for participants receiving oseltamivir 75 mg. Only the participants available at the time point were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received intravenous (IV) zanamivir 300 milligrams (mg) twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'FG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'FG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '209'}, {'groupId': 'FG002', 'numSubjects': '205'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '178'}, {'groupId': 'FG002', 'numSubjects': '166'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}]}]}], 'preAssignmentDetails': 'Male and female adult and adolescent participants \\>=16 years of age hospitalized with documented influenza or suspected influenza were eligible for enrollment. A total of 626 participants were randomized, and 615 participants were included in the Intent-to-Treat Exposed (ITT-E) Population (pop)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '615', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'IV Zanamivir 300 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 300 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'BG001', 'title': 'IV Zanamivir 600 mg', 'description': 'Participants \\>=16 years of age received IV zanamivir 600 mg twice daily, adjusted for renal function for 5-10 days'}, {'id': 'BG002', 'title': 'Oral Oseltamivir 75 mg', 'description': 'Participants \\>=16 years of age received oral oseltamvir 75 mg twice daily, adjusted for renal function for 5-10 days.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '18.88', 'groupId': 'BG000'}, {'value': '57.3', 'spread': '17.39', 'groupId': 'BG001'}, {'value': '55.9', 'spread': '18.7', 'groupId': 'BG002'}, {'value': '56.2', 'spread': '18.32', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '285', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '330', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American or African Heritage', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Asian - Central South Asian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}, {'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'White - Arabic or North African', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'White -White or Caucasian or European', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '466', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Mixed Race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 626}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'dispFirstSubmitDate': '2015-12-10', 'completionDateStruct': {'date': '2015-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-14', 'studyFirstSubmitDate': '2010-10-28', 'dispFirstSubmitQcDate': '2015-12-10', 'resultsFirstSubmitDate': '2017-04-11', 'studyFirstSubmitQcDate': '2010-10-28', 'dispFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-17', 'studyFirstPostDateStruct': {'date': '2010-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Clinical Response (TTCR) in Participants With Confirmed Influenza', 'timeFrame': 'Up to 42 days', 'description': 'Clinical response is defined as the resolution of at least 4 of the 5 vital signs (temperature, oxygen saturation, respiratory status, heart rate, systolic blood pressure) within the respective resolution criteria, maintained for at least 24 hours, or hospital discharge, whichever occurred first. This analysis was performed for Influenza positive population, for those with symptom onset less than or equal to (\\<=) 4 days, and for those on mechanical (mech) ventilation or in intensive care unit (ICU). 99 days is censored time for the participants who did not achieve TTCR.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Respiratory Improvement', 'timeFrame': 'Up to 42 days', 'description': 'Respiratory Status (RS) is a component of TTCR. Response criteria included the return to the pre-morbid oxygen requirement (participants with chronic oxygen use), a need for supplemental oxygen (administered by any modality: ventilator, non-invasive ventilation, facemask, facetent, nasal canula, etc.) to no need for supplemental oxygen, or a respiratory rate of =\\<24 breaths/minute (without supplemental oxygen). Data are presented as the percentage of participants achieving respiratory improvement.'}, {'measure': 'Number of Participants With All Cause and Attributable Mortality at Day 14, at Day 28, and at the End of Study Visit', 'timeFrame': 'On or before Day 14, Day 28, End of Study Visit (assessed up to 42 days)', 'description': 'The number of participants who died on or before Day 14, Day 28, and the End of Study Visit were summarized.'}, {'measure': 'Change From Baseline in the Katz Activities of Daily Living (ADL) Score and Each ADL Activity Score', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'The Katz ADL scores were collected for bathing, dressing, toileting, transferring, continence, and feeding activities and were assessed once daily during the treatment period/hospitalization and once at each post-treatment Clinic Visit. For the six individual activities, a score of 1 indicates independence, and a score of 0 indicates dependence. The total score is generated by adding the scores of all six activities. A total score of 6 indicates that the participant was independent; a total score of 0 indicates that the participant was very dependent. Baseline is defined as the pre-dose value collected on Study Day 1. Change from Baseline is defined as the difference at each time point (Day 5/6, and Day 10/11, and last day S/R if treatment was extended beyond 5 days) and the end of the study (post-treatment \\[PT\\] +28 Days) compared to Baseline.'}, {'measure': 'Median Time to Return to Pre-morbid Functional Status as Measured by the Katz ADL Score and Each ADL Activity Score', 'timeFrame': 'Up to 42 days', 'description': 'Pre-morbid functional status is defined as the best functional status in the 4 weeks prior to enrolment. Median time to return to pre-morbid functional status was assessed via the Katz ADL score (bathing, dressing, toileting, transferring, continence, and feeding activities). For the six individual activities, a score of 1 indicates independence, and a score of 0 indicates dependence. The total score is generated by adding the scores of all six activities. A total score of 6 indicates that the participant was independent; a total score of 0 indicates that the participant was very dependent.'}, {'measure': 'Number of Participants Who Returned to Their Pre-morbid Functional Status as Assessed Per the Katz ADL Score and Each ADL Activity Score at the End of the Study', 'timeFrame': 'Up to 42 days', 'description': 'Pre-morbid functional status is defined as the best functional status in the 4 weeks prior to enrolment. The number of participants who returned to their pre-morbid functional status at the end of the study assessed per the Katz ADL score (bathing, dressing, toileting, transferring, continence and feeding activities) is summarized.'}, {'measure': 'Median Time to Return to the Pre-morbid Level of Activity as Measured by the 3-point Scale', 'timeFrame': 'Up to 42 days', 'description': 'Median time to return to pre-morbid level of activity was assessed once daily during treatment/hospitalization and once at each post-treatment assessment and was measured using the 3- point scale (bed rest, limited ambulation, or unrestricted).'}, {'measure': 'Number of Participants With the Indicated Clinical Symptoms of Influenza', 'timeFrame': 'Up to 42 days', 'description': 'Influenza clinical symptoms included nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea, and vomiting. Influenza symptoms were assessed once daily during inpatient hospitalization and once at each post-treatment assessment.'}, {'measure': 'Median Time of Duration of Clinical Symptoms of Influenza', 'timeFrame': 'Up to 42 days', 'description': 'Influenza clinical symptoms included nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea, and vomiting. Influenza symptoms were assessed once daily during inpatient/hospitalization and once at each post-treatment assessment.'}, {'measure': 'Number of Participants With Complications of Influenza and Associated Antibiotic Use', 'timeFrame': 'Up to 42 days', 'description': 'The number of participants with complications of influenza and associated antibiotic use were summarized'}, {'measure': 'Number of Participants With the Indicated Ventilation Status: Modality of Invasive and Non-invasive Ventilator Support and Oxygen Supplementation', 'timeFrame': 'Up to 42 days', 'description': 'Ventilation status was assessed three times daily during the treatment period/hospitalization. Ventilation status was assessed once daily during inpatient/hospitization and once at each post-treatment clinic visit. The number of participants reported for machine-assisted: extracorporeal membrane oxygenation (ECMO), endotracheal mechanical ventilation, and supplemental oxygen delivery (SOD), no supplemental oxygen (O2) or ventilation support, Respiratory support at "any time (AT) on study" and at Baseline (Day 1) are summarized. Data for the "any time (AT) on study" time point was reported.'}, {'measure': 'Median Time of Duration of Invasive and Non-invasive Ventilator Support and Oxygen Supplementation', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Ventilation status was assessed three times daily during the treatment period/hospitalization. Ventilation status was assessed once daily during inpatient/hospitalization and once at each post-treatment clinic visit.'}, {'measure': 'Median Time of Duration of Hospitalization and Intensive Care Unit (ICU) Stay', 'timeFrame': 'Day 1 to the end of the study (assessed up to 42 days)', 'description': 'Hospital duration and ICU duration was assessed from the first day of dosing. Hospital duration was calculated as the discharge date minus the admission date + 1. Hospital duration while on study was the earlier of discharge, completion, or withdrawal minus the later of the admission date or the study start date + 1. ICU duration-Modified was calculated as the original ICU duration minus ICU days prior to Study Day 1.'}, {'measure': 'Median Time to the Absence of Fever and Improved Respiratory Status, Oxygen Saturation, Heart Rate, and Systolic Blood Pressure', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'The absence of fever is defined as a non-axillary temperature recording \\<=36.6 degrees Celsius axillary, \\<= 37.2 degrees Celsius oral or \\<= 37.7 degrees Celsius core. Respiratory Status (RS) response criteria included the return to the pre-morbid oxygen requirement (participants with chronic oxygen use), or the need for supplemental oxygen (administered by any modality: ventilator, non-invasive ventilation, facemask, facetent, nasal canula, etc.) to no need for supplemental oxygen, or a respiratory rate =\\<24 breaths/minute (without supplemental oxygen). Oxygen saturation response criteria: \\>=95% (without supplemental oxygen). Heart rate response criteria: =\\<100 beats/minute. Systolic blood pressure response criteria: \\>=90 millimeters of mercury. Vital signs were assessed three times daily during the treatment period/hospitalization. Vital signs were assessed once daily during inpatient/hospitization and once at each post-treatment clinic visit.'}, {'measure': 'Median Time to Virologic Improvement', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Virologic improvement is defined as a 2 log drop in viral load or sustained undetectable viral ribonucleic acid (RNA) (on two successive occasions) as measured by quantitative reverse transcriptase-polymerase chain reaction (RT-PCR) from nasopharyngeal samples. Nasopharyngeal swabs were collected daily from Baseline through Day 5. If randomized treatment was continued beyond Day 5, samples were taken on Treatment Days 6, 8, 10 and on the last day of randomized treatment. For participants who utilized the Switch (S)/Rescue (R) option, samples were taken on S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6, whichever was the last day of S/R treatment. Nasopharyngeal swabs were taken if the participant was symptomatic and continued to be hospitalized on the Post-Treatment +2, +5, +9, +16, and +28 day assessment.'}, {'measure': 'Change From Baseline in Quantitative Virus Culture From Nasopharyngeal Swabs Positive at Baseline', 'timeFrame': 'Baseline (Day 1), Day 3, Day 5, Day 8, Day 10, Day 11 and/or last day of randomized treatment, if randomized treatment was extended beyond 5 days, and S/R Day 5/6 (up to Day 14) if applicable', 'description': 'Nasopharyngeal swabs were collected daily from Baseline through Day 5. If randomized treatment was continued beyond Day 5, samples were taken on Treatment Day 6, Day 8, Day 10, Day 11, and the last day of randomized treatment. For participants who utilized the S/R option, samples were taken on S/R Day1, S/R Day3, S/R Day5, or S/R Day6, whichever was the last day of S/R treatment. Samples were taken if the participant was symptomatic and continued to be hospitalized on the Post-Treatment +2, +5, +9, +16 and +28Day assessment. Viral load was measured by Quantitative Virus Culture, log10 50% Tissue Culture Infectious Dose (TCID50)/milliliter (mL). Baseline is defined as the pre-dose value collected on Study Day 1. Change from Baseline was calculated as the post-Baseline value minus Baseline value .'}, {'measure': 'Change From Baseline Viral Load (Influenza A or B) by qPCR From Nasopharyngeal Swabs Positive at Baseline', 'timeFrame': 'Baseline (Day 1), Day 3, Day 5, Day 8, Day 10, Day 11 and/or last day of randomized treatment, if randomized treatment was extended beyond 5 days, and S/R Day 5/6 (up to Day 14) if applicable', 'description': 'Nasopharyngeal swabs were collected daily from Baseline through Day 5. If randomized treatment was continued beyond Day 5, samples were taken on Treatment Day 6, Day 8, Day 10, Day 11, and the last day of randomized treatment. For participants who utilized the S/R option, samples were taken on S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6, whichever was the last day of S/R treatment. Samples were taken if the participant was symptomatic and continued to be hospitalized on the post-treatment +2, +5, +9, +16 and +28 day assessment. Viral load as measured by PCR. Baseline is defined as the pre-dose value collected on Study Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.'}, {'measure': 'Number of Participants With no Detectable Viral RNA and the Absence of Cultivable Virus in Lower Respiratory Samples (Bronchoalveolar Lavage Sample [BAL], Endotracheal Aspirate)', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Lower respiratory samples included BAL and endotracheal aspirates. Endotracheal aspirates were requested in participants (par.) who were intubated. Upper (nasopharyngeal swabs) and lower (Endotracheal aspirates, bronchoalveolar lavage samples) respiratory samples were collected daily from Baseline/Day 1 through Day 5 and Day 6 (if the last day of randomized treatment \\[trt\\]). Endotracheal aspirates were collected in participants who were intubated. If trt was continued beyond Day 5, additional samples were taken on Trt Day 6, Day 8, Day 10, and/or the day of the last dose of randomized trt, if applicable, and S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6 if the last day of S/R trt. If the par. was symptomatic and hospitalized, samples were taken on the Post-Trt +2, +5, +9, +16 assessment days, and at the Post-Trt \\[PT\\]+28 Day assessment. Assessment of samples was done by quantitative RT-PCR and viral culture.'}, {'measure': 'Median Time to no Detectable Viral RNA and the Absence of Cultivable Virus in Any Obtained Sample (Upper and Lower Respiratory Samples)', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Upper (nasopharyngeal swabs) and lower (Endotracheal aspirates, bronchoalveolar lavage samples, where available) respiratory samples were collected daily from Baseline/Day 1 through Day 5 and Day 6 (if the last day of randomized treatment). Endotracheal aspirates were collected in participants who were intubated. If treatment was continued beyond Day 5, additional samples were taken on Treatment Day 6, Day 8, Day 10, and/or the day of the last dose of randomized treatment, if applicable, and S/R Day 1, S/R Day 3, S/R Day 5, or S/R Day 6 if the last day of S/R treatment. If the participant was symptomatic and hospitalized, samples were taken on the Post-treatment+2, +5, +9, +16 assessment days, and at the Post-Treatment +28 Day. Assessment of samples was done by quantitative RT-PCR.'}, {'measure': 'Number of Participants With Resistance-associated Mutations Detected in the Neuraminidase (NA) and Hemagglutinin (HA) Gene of Influenza A and B Viruses in Nasopharyngeal Swabs and Endotracheal/BAL Samples', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Nasopharyngeal swabs and endotracheal /BAL samples were collected for viral susceptibility analysis. Susceptibility analyses consisted of phenotyping and genotyping. Resistance mutations were detected by genotyping. Viral susceptibility to zanamivir and oral oseltamivir at Baseline and throughout treatment determined by NA and HA (gene of influenza A and B viruses) sequence analysis and NA enzyme inhibition. Number of participants with viral mutation events are summarized, this includes all resistance mutations (substitutions) i.e. those present at Baseline and those that emerged during treatment.'}, {'measure': 'Number of Participants With Any Adverse Event (AE) Considered to be Related to Study Treatment', 'timeFrame': 'Up to 42 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. All AEs were assessed by the Investigator as related or not related to the study treatment.'}, {'measure': 'Number of Participants With Any Severe or Grade 3/4 AE', 'timeFrame': 'Up to 42 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. AEs that occurred during the study were evaluated by the Investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of AEs. Grade 3=severe; Grade 4=potentially life threatening.'}, {'measure': 'Number of Participants Who Permanently Discontinued the Study Treatment Due to an AE', 'timeFrame': 'Up to 42 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse.'}, {'measure': 'Number of Participants Who Were Permanently Discontinued From the Study Due to an AE', 'timeFrame': 'Up to 42 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse.'}, {'measure': 'Number of Participants With Any Severe or Grade 3/4 Treatment-related AE', 'timeFrame': 'Up to 42 days', 'description': 'An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. AEs that occurred during the study were evaluated by the Investigator and graded according to the DAIDS table for grading the severity of adult and pediatric AEs. Grade 3=severe; Grade 4=potentially life threatening. All AEs were assessed by the Investigator as related or not related to the study treatment.'}, {'measure': 'Number of Participants With the Indicated Chemistry Laboratory Values Shifts From Baseline (Day 1) and up to 42 Days', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Samples for laboratory assessments were collected at Baseline (Day 1), Day 3, Day 5/6, Day 8, Day 10/11 (or last day of randomized treatment), switch/rescue (S/R) Day 1, S/R Day 3, and S/R Day 5/6 (last day of S/R treatment for those participants who utilized this option), Post-Treatment +2 (if hospitalized), and Post-Treatment +5, +16, and +28 Days. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino tranferase (AST), total bilirubin, calcium, creatine kinase, chloride, carbon dioxide content (CO2), creatinine, potassium, magnesium, sodium. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade (G) 1=mild, G2= moderate, G3=severe and G4=potentially life threatening. The number of participants with values that were G1, G2, G3 and G4 relative to the normal range are summarized.'}, {'measure': 'Number of Participants With the Indicated Hematology Values Shifts From Baseline (Day 1) and up to 42 Days', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'Blood samples for laboratory assessments were collected at Baseline (Day 1), Day 3, Day 5/6, Day 8, Day 10/11 (or last day of randomized treatment), S/R Day 1, S/R Day 3, and S/R Day 5/6 (last day of S/R treatment for those participants who utilized this option), Post-Treatment +2 (if hospitalized), and Post-Treatment +5, +16, and +28 Days. Hematology parameters included hemoglobin, lymphocytes, total neutrophils, platelet count, and white blood cell (WBC) count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade (G) 1=mild, G2= moderate, G3=severe and G4=potentially life threatening. The number of participants with values that were G1, G2, G3 and G4 relative to the normal range for the indicated hematology parameters is summarized. Baseline is defined as the pre-dose value collected on Study Day 1.'}, {'measure': 'Number of Participants With the Indicated Treatment-emergent (TE) Grade (G) 3/4 Clinical Chemistry Toxicities', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatine kinase, chloride, CO2/bicarbonate, creatinine, potassium, magnesium and sodium. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the pre-dose value collected on Study Day 1.'}, {'measure': 'Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Hematology Toxicities', 'timeFrame': 'Baseline (Day 1) and up to 42 days', 'description': 'A toxicity was considered to be TE if it was greater than the Baseline grade, and if it had developed or increased post-Baseline in intensity (and prior to the last dose of investigational product). The hematology parameters included hemoglobin, lymphocytes, total neutrophils, platelet count, and WBC count. Per the DAIDS table for grading the severity of adult and pediatric AEs, Grade 3=severe and Grade 4=potentially life threatening. Baseline is defined as the pre-dose value collected on Study Day 1.'}, {'measure': 'Median Quantity of Oxygen Delivery Measured at Baseline (Day 1) and During the Study', 'timeFrame': 'Baseline (Day 1) and during the study', 'description': 'Oxygen delivery were assessed three times daily at Baseline (Day 1) and during the treatment period/hospitalization (ideally at least 6 hours apart) and once daily during inpatient/hospitalization and once at Post +5 days, +16 days, and +28 days clinic visits. The median quantity of oxygen delivery during the study was not summarized since the data was not collected in a way to accurately calculate values. Baseline is defined as the pre-dose value collected on Study Day 1.'}, {'measure': 'Number of Participants Assessed as Normal/Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at Baseline (Day 1) and Day 4', 'timeFrame': 'Baseline (Day 1) and Day 4', 'description': 'On Baseline/Day 1, a 12-lead ECG was obtained within approximately 24 hours prior to dosing. The number of participants with an ECG status of normal and abnormal CS or NCS, as determined by the Investigator, is reported. Normal=all ECG parameters within the accepted normal ranges. Abnormal=ECG findings outside of normal ranges. CS=ECG with a CS abnormality that meets exclusion criteria. NCS=ECG with an abnormality that is not CS nor meets exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. In the original protocol ECGs were also done on Day 4, however, amendment 2 removed this requirement and therefore not all participants had Day 4 ECGs.'}, {'measure': 'Serum Concentration of IV Zanamivir', 'timeFrame': 'Day 1 and Day 4', 'description': 'Pharmacokinetic samples were collected at four time points to characterize peak concentration (end of infusion; C\\[EOI\\]) after the first dose on Day 1 and on Day 4 to characterize the pre-dose concentration (C\\[0\\]), the peak concentration C(EOI), and the trough concentration at 11-12 hours post-dose (C\\[12\\]) of zanamavir. Data was summarized by Creatinine clearance (CL) Category. The dose on Day 1 is the initial dose (unadjusted) and the dose on Day 4 is the maintenance dose.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Seasonal Influenza', 'Pandemic', 'Orthomyxoviridae Infections', 'Influenza', 'Influenza A Virus, H1N1 Subtype', 'Enzyme Inhibitors', 'Influenza, seasonal', 'Respiratory Tract Diseases', 'Zanamivir', 'Pharmacologic Actions', 'Antiviral Agents', 'Anti-Infective Agents', 'H1N1', 'Neuraminidase inhibitor', 'Influenza B virus'], 'conditions': ['Influenza, Human']}, 'referencesModule': {'availIpds': [{'id': '114373', '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': '114373', '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': '114373', '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': '114373', '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': '114373', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '114373', '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': '114373', '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': '36202198', 'type': 'DERIVED', 'citation': 'van Duijnhoven W, Van Dromme I, Haesendonckx S, Witek J, Leopold L. The Hospital Recovery Scale: A clinically useful endpoint in patients hospitalized with influenza. Contemp Clin Trials. 2022 Dec;123:106952. doi: 10.1016/j.cct.2022.106952. Epub 2022 Oct 3.'}, {'pmid': '28094141', 'type': 'DERIVED', 'citation': 'Marty FM, Vidal-Puigserver J, Clark C, Gupta SK, Merino E, Garot D, Chapman MJ, Jacobs F, Rodriguez-Noriega E, Husa P, Shortino D, Watson HA, Yates PJ, Peppercorn AF. Intravenous zanamivir or oral oseltamivir for hospitalised patients with influenza: an international, randomised, double-blind, double-dummy, phase 3 trial. Lancet Respir Med. 2017 Feb;5(2):135-146. doi: 10.1016/S2213-2600(16)30435-0. Epub 2017 Jan 14.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the safety and efficacy of zanamivir given intravenously and how well it works at two different doses in hospitalized adolescents and adults with flu. Zanamivir will be compared with oseltamivir, which is used for treating flu.', 'detailedDescription': 'The recent influenza pandemic has highlighted the need for alternative formulations for anti-influenza therapies. This will be an international Phase III, double-blind, double-dummy, 3-arm study to evaluate the efficacy, antiviral activity and safety of IV zanamivir 600 mg twice daily compared to oral oseltamivir 75 mg twice daily, and 600 mg IV zanamivir twice daily compared to 300 mg IV zanamivir for 5 days in hospitalized subjects with laboratory confirmed or suspected influenza infection. For a given subject, the initial 5-day treatment course may be extended for up to 5 additional days if clinical symptoms or patient characteristics as assessed by the investigator warrant further treatment. Alternatively, if the investigator considers that a subject is failing to improve clinically on their randomized treatment, the investigator can choose to initiate the switch/rescue option (600 mg IV zanamivir twice daily) on any day from Day 6 through Day 10 for up to an additional 5 days of treatment. On switching treatments, subjects complete a maximum of 14 days of treatment and are followed-up to Post-Treatment +28 Days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female aged 16 years; a female is eligible to enter and participate in the study if she is:\n\n 1. of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post- menopausal); or,\n 2. of child-bearing potential, has a negative pregnancy test at Baseline, and agrees to use protocol specified methods of birth control while on study.\n* Vital signs criteria defined as 3 or more of the following at Baseline:\n\n 1. Presence of fever \\[oral temperature of 38°C or equivalent\\] at Baseline. However, this requirement is waived if the subject has a history of fever within in the 24 hours prior to Baseline; or, if the subject reported symptoms of feverishness at some time during the 48 hours prior to Baseline.\n\n AND at least 2 out of the following 4:\n 2. Oxygen saturation \\<95% on room air by trans-cutaneous method or need for any supplemental oxygenation or ventilatory support, or increase in oxygen supplementation requirement of ≥2 litres for subjects with chronic oxygen dependency. For those subjects with a history of chronic hypoxia (without supplemental oxygen), an oxygen saturation of at least 3% below the patient's historical baseline oxygen saturation will satisfy this criterion.\n 3. Respiration rate \\>24 breaths per minute. For those subjects who require ventilatory support or oxygen supplementation, this requirement is waived.\n 4. Heart rate \\>100 beats per minute.\n 5. Systolic blood pressure \\<90 mmHg.\n* Onset of influenza symptoms within 6 days prior to study enrolment. Symptoms may include cough, dyspnea, sore throat, feverishness, myalgias, headache, nasal symptoms (rhinorrhea, congestion), fatigue, diarrhea, anorexia, nausea and vomiting.\n* Clinical symptoms of influenza with positive influenza diagnostic test result or strong suspicion of influenza illness based on clinical symptoms and local surveillance information.\n* Subjects willing and able to give written informed consent to participate in the study and to adhere to the procedures stated in the protocol, or legally acceptable representative willing and able to give written informed consent on behalf of the subject for minors, unconscious adults and those incapable of consenting themselves due to their medical condition, or included as permitted by local regulatory authorities, IRB/IECs or local laws.\n* Severity of any medical illness that, in the Investigator's judgement, justifies hospitalization of the subject for treatment and supportive care\n* French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category\n\nExclusion Criteria:\n\n* Subjects who have taken more than a total of 3 days (6 doses) of approved anti-influenza therapy in the period from onset of symptoms and prior to enrolment.\n* Subjects who, in the opinion of the investigator, are not likely to survive beyond 48 hours from Baseline.\n* Subjects who are considered to require concurrent therapy with another influenza antiviral medication.\n* Subjects who are known or suspected to be hypersensitive to any component of the study medications.\n* Subjects with creatinine clearance ≤10 mL/min who are not being treated with continuous renal replacement therapy (CRRT).\n* Subjects who require Extra Corporeal Membrane Oxygenation (ECMO) at Baseline\n* Subjects who require routine/intermittent hemodialysis or continuous peritoneal dialysis (due to inability to provide appropriate dosing schedule for oseltamivir) at Baseline. CRRT modalities are allowed.\n* Liver toxicity criteria based on local laboratory results obtained within 24 hours of Baseline:\n\n 1. ALT or AST 3xULN and bilirubin 2xULN\n 2. ALT 5xULN\n* Underlying chronic liver disease with evidence of severe liver impairment.\n* History of severe cardiac disease or clinically significant arrhythmia (either on ECG or by history) which, in the opinion of the Investigator, will interfere with the safety of the individual subject.\n* Females who are pregnant or are breastfeeding.\n* Treatment with investigational parenteral anti-influenza drugs (IV peramivir, IV zanamivir or IV oseltamivir) in the 4 weeks prior to Baseline.\n* French and Korean subjects: the French or Korean subject has participated in any study using an investigational drug during the previous 30 days."}, 'identificationModule': {'nctId': 'NCT01231620', 'acronym': 'ZORO', 'briefTitle': 'A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase III International, Randomized, Double-blind, Double-dummy Study to Evaluate the Efficacy and Safety of 300 mg or 600 mg of Intravenous Zanamivir Twice Daily Compared to 75 mg of Oral Oseltamivir Twice Daily in the Treatment of Hospitalized Adults and Adolescents With Influenza', 'orgStudyIdInfo': {'id': '114373'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous (IV) Zanamivir 300mg Twice Daily', 'description': '300mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily', 'interventionNames': ['Drug: Zanamivir', 'Drug: Placebo to match oseltamivir']}, {'type': 'EXPERIMENTAL', 'label': 'Intravenous (IV) Zanamivir 600mg Twice Daily', 'description': '600mg of IV zanamivir infusion twice daily plus oral oseltamivir placebo twice daily', 'interventionNames': ['Drug: Zanamivir', 'Drug: Placebo to match oseltamivir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Oseltamivir 75mg Twice Daily', 'description': '75mg oral oseltamivir twice daily plus intravenous placebo zanamivir twice daily', 'interventionNames': ['Drug: Placebo to match zanamivir', 'Drug: Oseltamivir']}], 'interventions': [{'name': 'Zanamivir', 'type': 'DRUG', 'otherNames': ['Relenza'], 'description': 'Zanamivir aqueous solution, 10 mg/mL, will be provided as a single use, sterile clear, colorless preparation in 20 mL clear glass vials.', 'armGroupLabels': ['Intravenous (IV) Zanamivir 300mg Twice Daily', 'Intravenous (IV) Zanamivir 600mg Twice Daily']}, {'name': 'Placebo to match zanamivir', 'type': 'DRUG', 'description': 'Placebo to match IV zanamivir will be provided as a normal saline solution of a matched volume.', 'armGroupLabels': ['Oral Oseltamivir 75mg Twice Daily']}, {'name': 'Oseltamivir', 'type': 'DRUG', 'otherNames': ['Tamiflu'], 'description': 'Oseltamivir will be provided as over-encapsulated 75 mg capsules.', 'armGroupLabels': ['Oral Oseltamivir 75mg Twice Daily']}, {'name': 'Placebo to match oseltamivir', 'type': 'DRUG', 'description': 'Placebo to match oral oseltamivir will be provided as capsules with a common excipient of appropriate quality.', 'armGroupLabels': ['Intravenous (IV) Zanamivir 300mg Twice Daily', 'Intravenous (IV) Zanamivir 600mg Twice Daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 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Site', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60302', 'city': 'Oak Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.88503, 'lon': -87.7845}}, {'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '51503', 'city': 'Council Bluffs', 'state': 'Iowa', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.26194, 'lon': -95.86083}}, {'zip': '66604', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '40241', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '48085', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '63110-1093', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59802', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27599-7215', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '58504', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43608', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '18105', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '24013', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '5043', 'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 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'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G7H 5H6', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 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