Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT01227967
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2010-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'D053139', 'term': 'Oseltamivir'}], 'ancestors': [{'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jbeigel@niaid.nih.gov', 'phone': '301-451-9881', 'title': 'John Beigel, M.D.', 'organization': 'Leidos Biomedical Research, Inc. is support to the National Institute of Allergy and Infectious Diseases (NIAID)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected throughout the conduct of the study; from Day 0 to Day 28', 'description': 'All worsening and new symptoms were evaluated as potential adverse events.If a diagnosis was clinically evident (or subsequently determined), the diagnosis, rather than the individual signs and symptoms or lab abnormalities, were recorded as the AE. All worsening laboratory values were also evaluated as potential adverse events. The DAIDS AE Grading Table (V1.0) was used.', 'eventGroups': [{'id': 'EG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.', 'otherNumAtRisk': 314, 'deathsNumAtRisk': 314, 'otherNumAffected': 148, 'seriousNumAtRisk': 314, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.', 'otherNumAtRisk': 312, 'deathsNumAtRisk': 312, 'otherNumAffected': 163, 'seriousNumAtRisk': 312, 'deathsNumAffected': 1, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Personality change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 314, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.046', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10', 'ciLowerLimit': '-19.8', 'ciUpperLimit': '-0.2', 'pValueComment': 'P-value was not adjusted for multiple interim analyses.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5', 'estimateComment': 'The difference in percents was calculated as the percent detectable in the Combination Therapy minus the percent detectable in the Oseltamivir Monotherapy.', 'groupDescription': 'Assuming that pooled percentage of participants with virus detectable by PCR at Day 3 is 50%, assuming that the Combination Therapy was better than the Oseltamivir Monotherapy and that the detectable rate in the Combination Therapy was 42.5% compared to 57.5% in the Oseltamivir Monotherapy (a 15% reduction), and assuming 10% subjects with missing qPCR at Day 3, in a two-sided, two-sample 0.05-level t- test with 546 participants combined across both arms, there was 90% power.', 'statisticalMethod': 'Z-test, 2-sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Comparison of randomized arms was based on the normal approximation to the binomial distribution.'}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 3', 'description': 'The central laboratory performed a qualitative PCR test on the NP sample from Day 0 in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was restricted to the 407 participants who had a confirmed positive test for influenza by qPCR in the central laboratory testing and were not in the pilot study for IRC003. 13 participants (5 in the Combination Therapy and 8 in the Oseltamivir Monotherapy) had missing endpoint samples so were excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by Virus Detection Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'title': 'Day 0', 'categories': [{'title': '>=LLOQ', 'measurements': [{'value': '221', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}, {'title': '>=LOD, <LLOQ', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': '<LOD', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'title': '>=LLOQ', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}, {'title': '>=LOD, <LLOQ', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': '<LOD', 'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'title': '>=LLOQ', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': '>=LOD, <LLOQ', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '<LOD', 'measurements': [{'value': '193', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Day 0, 3 and 7.', 'description': 'Number of participants who had undetectable values (less than the limit of detection \\[LOD\\]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.'}, {'type': 'SECONDARY', 'title': 'qPCR Viral Shedding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '7.2'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '7.7'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '4.2'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '4.95'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '3.4'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '3.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Day 0, 3 and 7', 'description': 'Median, 25% and 75% percentile of the value of viral shedding (Results \\<LOD were imputed as the LOD value, and Results \\>= LOD, \\<LLOQ were imputed as the LLOQ value.)', 'unitOfMeasure': 'Log10 copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Shedding Virus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'categories': [{'title': 'Undetectable at both Day 3 and 7', 'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}, {'title': 'Detectable at Day 3 and undetectable at Day 7', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}, {'title': 'Detectable at Day 7', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': 'Missing result at Day 3 and/or Day 7', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At day 3 and 7.', 'description': 'Number of participants with undetectable viral load at both Day 3 and Day 7; detectable at Day 3 and undetectable at Day 7; detectable at Day 7 (irrespective of whether or not detectable at Day 3).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Primary Efficacy Population (PEP), which included all participants who were randomized properly, had received at least one dose of study drug, and had influenza virus isolated and typed in the qualitative PCR evaluation at Day 0 from central laboratory testing.'}, {'type': 'SECONDARY', 'title': 'Time to Alleviation of Influenza Clinical Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '5.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '4.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment initiation to Day 28', 'description': "The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Duration of clinical symptoms is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1 (mild). A measurement is considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements are obtained per day) and then the daily assessment thereafter. Time will then be calculated in half-days through to Day 7. If a subject's first two assessments on (baseline assessment and first subsequent diary card assessment) satisfy this criterion, then the duration will be set to zero. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms evaluated.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Absence of Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'comment': 'Not estimable', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.5', 'comment': 'Not estimable', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Otherwise, fever was considered not present during the period since the diary card was previously completed, except that the evaluation was considered missing if either the temperature or the antipyretic drug use entry was not completed on the diary card. The duration of fever was defined as the time from Day 0 to the first of two successive assessments (through to Day 7) or to the first assessment (Day 8 onwards) at which no fever was present according to this definition.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with fever evaluated.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Resolution of All Symptoms AND Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '5.0'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Time to resolution of all clinical symptoms and fever is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1(mild) and no fever \\>=38.0 C or antipyretic drug is reported. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms and fever evaluated.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Intention To Treat (ITT) Population, which includes all participants who were randomized properly and who had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Feeling as Good as Before the Onset of the Influenza Illness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '7.5'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment initiation to Day 28', 'description': "Time to feeling as good as before influenza is defined as time to the first of two successive 'yes' responses to the question of 'feeling as good as you did before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Return to Pre-influenza Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '7.5'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '6.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment initiation to Day 28', 'description': "Time to return to pre-influenza function is defined as the time from Day 0 to the first of two successive 'Yes' answers to the global assessment question 'Are you functioning as well as you were before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Return of Physical Function to Pre-illness Leve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '8.0'}, {'value': '6.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'Time to return of physical function to pre-illness level was defined as the time from Day 0 to the first of two successive measurements at which the physical function score equals or is better than the pre-illness score (obtained by recall at enrollment).For subjects who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with physical function evaluated.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Failure at Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'Clinical failure at Day 5 is defined as the need for continued (non-study) antiviral use after Day 5.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'title': 'Sinustis', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Otitis Media', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchitis Bronchiolitis', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Antibiotic use for other reasons', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'At least one complication and/or use of antibiotic', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'Participants were assessed for the signs/symptoms suggestive of one of the following complications: Sinusitis, Otitis Media ,Bronchitis / Bronchiolitis, Pneumonia and antibiotic use for reason other than above.', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug. The categories in the table are not mutually exclusive (because some participants had multiple complications) and the last row of the table summarizes all incidents.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Required New or Increased Use of Supplemental Oxygen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.91', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'Percentage of participants who required new or increased use of supplemental oxygen', 'unitOfMeasure': 'percentage of participants analyzed', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Required Hospitalization.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.28', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6.56'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '-0.12', 'upperLimit': '2.08'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'The percentage of participants hospitalized by 28 days was estimated from the Kaplan-Meier curves.', 'unitOfMeasure': 'percentage of participants analyzed', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': '28-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'OG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'Number of deaths', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Intention To Treat (ITT) Population, which included all participants who were randomized properly and who had received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'FG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '314'}, {'groupId': 'FG001', 'numSubjects': '316'}]}, {'type': 'COMPLETED', 'comment': 'Results were through database cutoff (10 November 2016) for efficacy analysis (through Day 28 visit)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '303'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Never Started Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Taking Additional Antiviral Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Outpatient or hospitalized participants at high risk for complications and morbidity, diagnosed with influenza by rapid antigen or PCR were recruited at 65 sites from 5 countries: 52 from the U.S., 2 from Australia, 3 from Mexico, and 4 each in Thailand and Argentina, between March 2011 to April 2016.', 'preAssignmentDetails': 'Eight hundred eighty-one subjects were enrolled per protocol (signed consent). Two hundred fifty-one subjects were excluded during screening and did not participate in any other aspect of the trial. Three subjects were randomized improperly because they were given study drug kit prior to the randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Combination Therapy', 'description': 'Drug: Amantadine, Ribavirin, Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.'}, {'id': 'BG001', 'title': 'Oseltamivir Monotherapy', 'description': 'Drug: Oseltamivir\n\nSubjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '493', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.5', 'groupId': 'BG000', 'lowerLimit': '37', 'upperLimit': '61'}, {'value': '49.5', 'groupId': 'BG001', 'lowerLimit': '35.5', 'upperLimit': '61'}, {'value': '49.5', 'groupId': 'BG002', 'lowerLimit': '36', 'upperLimit': '61'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '385', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '241', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '512', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '392', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'American Indian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Race not available to clinic', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Subject does not want to report', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Subject does not know', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '436', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Thailand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Influenza Diagnostic Test by Local Testing', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'RT-PCR/PCR', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Rapid antigen test', 'measurements': [{'value': '281', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '562', 'groupId': 'BG002'}]}, {'title': 'Isothermal nucleic acid amplification technology', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Positive Influenza Test by Local Testing', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Result of Influenza Test By Local Testing', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Influenza A/H1N1', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Influenza A/H3N2', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Influenza A unsubtypable', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Influenza A not typed', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}, {'title': 'Influenza B', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}, {'title': 'Influenza positive (unknown A or B)', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Multiple types/subtypes', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Confirmed Influenza Infection Status By Central Testing', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '454', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Influenza Type/Subtype By Central Testing', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Influenza A/H3N2', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}, {'title': 'Influenza A/H1N1', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Influenza B', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Influenza type/subtype by central lab testing was from site-collected swab on Day 0 (the first one if more than one was collected) and if that was missing, then from a Day -1 sample, if collected', 'unitOfMeasure': 'Participants'}, {'title': 'Quantitative PCR Viral Shedding', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '454', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'BG000', 'lowerLimit': '5.6', 'upperLimit': '7.2'}, {'value': '6.7', 'groupId': 'BG001', 'lowerLimit': '5.1', 'upperLimit': '7.7'}, {'value': '6.5', 'groupId': 'BG002', 'lowerLimit': '5.4', 'upperLimit': '7.4'}]}]}], 'paramType': 'MEDIAN', 'description': 'Limit of detection (LOD)/lower limit of quantification (LLOQ) for Flu A and Flu B by qPCR is 3.2/3.9 and 3.4/4.0, respectively.\n\nResults \\<LOD were imputed as LOD; results \\>=LOD and \\<LLOQ were imputed as LLOQ, and results \\>ULOQ were imputed as ULOQ', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The results are for the 454 participants with a confirmed positive test for influenza on a Day 0 sample from the central laboratory using a RT-PCR for influenza type and subtype.'}, {'title': 'Presence of fever', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Symptom Score', 'classes': [{'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Absent', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Absent', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Feverishness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Absent', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Absent', 'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Muscle aches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Absent', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Absent', 'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '269', 'groupId': 'BG001'}, {'value': '537', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Absent', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Absent', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '395', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Sore throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Absent', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Stuffy nose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Absent', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Rhinorrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Absent', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Symptoms were scored on a 4-point scale : 0=absent, 1=mild, 2=moderate, 3=severe', 'unitOfMeasure': 'Participants'}, {'title': 'Overall Symptom Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000', 'lowerLimit': '11', 'upperLimit': '19'}, {'value': '15', 'groupId': 'BG001', 'lowerLimit': '11', 'upperLimit': '19'}, {'value': '15', 'groupId': 'BG002', 'lowerLimit': '11', 'upperLimit': '19'}]}]}], 'paramType': 'MEDIAN', 'description': 'Overall symptom score was the sum of available scores for each of the 11 symptoms assessed (so ignoring missing values). The possible range of the overall symptom score is therefore 0 (no symptoms) to 44 (severe for all 10 symptoms). Participants with missing evaluations for all symptoms were given a missing overall symptom score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Functional status', 'classes': [{'title': 'Vigorous activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Limited a lot = 0', 'measurements': [{'value': '238', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '476', 'groupId': 'BG002'}]}, {'title': 'Limited a little = 50', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Not limited at all = 100', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Moderate activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Limited a lot = 0', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '338', 'groupId': 'BG002'}]}, {'title': 'Limited a little = 50', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}, {'title': 'Not limited at all = 100', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Lifting groceries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Limited a lot = 0', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}, {'title': 'Limited a little = 50', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}, {'title': 'Not limited at all = 100', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Climbing stairs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Limited a lot = 0', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}]}, {'title': 'Limited a little = 50', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}]}, {'title': 'Not limited at all = 100', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Climbing 1 flight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Limited a lot = 0', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}, {'title': 'Limited a little = 50', 'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}, {'title': 'Not limited at all = 100', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Bending or kneeling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Limited a lot = 0', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}, {'title': 'Limited a little = 50', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}, {'title': 'Not limited at all = 100', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Walking > 1 mile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Limited a lot = 0', 'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}, {'title': 'Limited a little = 50', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': 'Not limited at all = 100', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Walking blocks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Limited a lot = 0', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}, {'title': 'Limited a little = 50', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}, {'title': 'Not limited at all = 100', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Walking a block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Limited a lot = 0', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': 'Limited a little = 50', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}, {'title': 'Not limited at all = 100', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Bathing/dressing self', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Limited a lot = 0', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Limited a little = 50', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}, {'title': 'Not limited at all = 100', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Average Functional Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '60'}, {'value': '35', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '55'}, {'value': '35', 'groupId': 'BG002', 'lowerLimit': '15', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'description': "Average functional status was calculated as the average of the ten items assessed (so ignoring missing values), scoring 0='yes, limited a lot', 50='yes, limited a little', 100='no, not limited at all'. The possible range of the functional status score is therefore 0 (worst possible status) to 100 (best possible status). Participants with missing evaluations for all items were given a missing average functional status.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Global assessment', 'classes': [{'title': 'Subject feels as good today as before flu', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '302', 'groupId': 'BG001'}, {'value': '603', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Subject functions as well today as before flu', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '287', 'groupId': 'BG000'}, {'value': '289', 'groupId': 'BG001'}, {'value': '576', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Complications of Influenza', 'classes': [{'title': 'Sinusitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '596', 'groupId': 'BG002'}]}, {'title': 'Unable to assess', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Otitis Media', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '307', 'groupId': 'BG000'}, {'value': '308', 'groupId': 'BG001'}, {'value': '615', 'groupId': 'BG002'}]}, {'title': 'Unable to assess', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Bronchitis/Bronchiolitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '599', 'groupId': 'BG002'}]}, {'title': 'Unable to assess', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Pneumonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '304', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '607', 'groupId': 'BG002'}]}, {'title': 'Unable to assess', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Using antibiotic for other reasons', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '291', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '582', 'groupId': 'BG002'}]}, {'title': 'Unable to assess', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Medical Conditions', 'classes': [{'title': '>= 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '247', 'groupId': 'BG001'}, {'value': '498', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}, {'title': 'Asthma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '427', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}, {'title': 'Neurological condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '293', 'groupId': 'BG001'}, {'value': '590', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Chronic Lung disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '588', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Heart disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '284', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '557', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'Blood disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '306', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '613', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Endocrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '451', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}]}, {'title': 'Kidney', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '306', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '612', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Liver disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '311', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '616', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Metabolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '606', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Weakened immune system', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '536', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}, {'title': 'BMI >= 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '240', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '501', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Medication conditions that may increase risk of complications from influenza which are used to determine eligibility for the study.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent To Treat (ITT) Population: all participants who were randomized properly and who had received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 881}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2010-10-22', 'resultsFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2010-10-22', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-10', 'studyFirstPostDateStruct': {'date': '2010-10-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Virus Detectable by Quantitative PCR (qPCR) in Nasopharyngeal (NP) Swabs', 'timeFrame': 'At Day 3', 'description': 'The central laboratory performed a qualitative PCR test on the NP sample from Day 0 in order to confirm influenza infection and to determine the influenza type and subtype. For participants with a positive influenza test result at Day 0 from this qualitative PCR testing, the laboratory then performed qPCR testing of subsequent samples to quantify viral shedding.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants by Virus Detection Status', 'timeFrame': 'At Day 0, 3 and 7.', 'description': 'Number of participants who had undetectable values (less than the limit of detection \\[LOD\\]), who had values between the LOD and the lower limit of quantification (LLOQ), and who had values ≥LLOQ'}, {'measure': 'qPCR Viral Shedding', 'timeFrame': 'At Day 0, 3 and 7', 'description': 'Median, 25% and 75% percentile of the value of viral shedding (Results \\<LOD were imputed as the LOD value, and Results \\>= LOD, \\<LLOQ were imputed as the LLOQ value.)'}, {'measure': 'Number of Participants Shedding Virus', 'timeFrame': 'At day 3 and 7.', 'description': 'Number of participants with undetectable viral load at both Day 3 and Day 7; detectable at Day 3 and undetectable at Day 7; detectable at Day 7 (irrespective of whether or not detectable at Day 3).'}, {'measure': 'Time to Alleviation of Influenza Clinical Symptoms.', 'timeFrame': 'From treatment initiation to Day 28', 'description': "The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Duration of clinical symptoms is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1 (mild). A measurement is considered to be the 8AM or 8PM assessment during Days 0 to 7 (so two measurements are obtained per day) and then the daily assessment thereafter. Time will then be calculated in half-days through to Day 7. If a subject's first two assessments on (baseline assessment and first subsequent diary card assessment) satisfy this criterion, then the duration will be set to zero. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms evaluated."}, {'measure': 'Time to Absence of Fever', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Otherwise, fever was considered not present during the period since the diary card was previously completed, except that the evaluation was considered missing if either the temperature or the antipyretic drug use entry was not completed on the diary card. The duration of fever was defined as the time from Day 0 to the first of two successive assessments (through to Day 7) or to the first assessment (Day 8 onwards) at which no fever was present according to this definition.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with fever evaluated.'}, {'measure': 'Time to Resolution of All Symptoms AND Fever', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'The assessed symptoms were cough, nasal obstruction (stuffy nose), sore throat, fatigue, headache, muscle aches, feverishness, rhinorrhea, nausea, vomiting, diarrhea. Fever was considered present based on the diary cards if a subject reported a maximal temperature ≥38.0°C (for the period since the diary card was previously completed) or reported having taken an antipyretic drug (also for the period since the diary card was previously completed). Time to resolution of all clinical symptoms and fever is defined as the time from Day 0 to the first of two successive measurements at which all clinical symptoms are grade 0 (absent) or 1(mild) and no fever \\>=38.0 C or antipyretic drug is reported. For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with symptoms and fever evaluated.'}, {'measure': 'Time to Feeling as Good as Before the Onset of the Influenza Illness', 'timeFrame': 'From treatment initiation to Day 28', 'description': "Time to feeling as good as before influenza is defined as time to the first of two successive 'yes' responses to the question of 'feeling as good as you did before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered."}, {'measure': 'Time to Return to Pre-influenza Function', 'timeFrame': 'From treatment initiation to Day 28', 'description': "Time to return to pre-influenza function is defined as the time from Day 0 to the first of two successive 'Yes' answers to the global assessment question 'Are you functioning as well as you were before you had the flu'.For participants who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with question answered."}, {'measure': 'Time to Return of Physical Function to Pre-illness Leve', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'Time to return of physical function to pre-illness level was defined as the time from Day 0 to the first of two successive measurements at which the physical function score equals or is better than the pre-illness score (obtained by recall at enrollment).For subjects who did not have two successive records meeting this criterion, follow-up was censored for analysis purposes at the time of the last but one diary card record with physical function evaluated.'}, {'measure': 'Percentage of Participants With Clinical Failure at Day 5', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'Clinical failure at Day 5 is defined as the need for continued (non-study) antiviral use after Day 5.'}, {'measure': 'Percentage of Participants Who Develop Bronchitis, Pneumonia, or Other Complications of Influenza After Day 0.', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'Participants were assessed for the signs/symptoms suggestive of one of the following complications: Sinusitis, Otitis Media ,Bronchitis / Bronchiolitis, Pneumonia and antibiotic use for reason other than above.'}, {'measure': 'Percentage of Participants Who Required New or Increased Use of Supplemental Oxygen', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'Percentage of participants who required new or increased use of supplemental oxygen'}, {'measure': 'Percentage of Participants Who Required Hospitalization.', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'The percentage of participants hospitalized by 28 days was estimated from the Kaplan-Meier curves.'}, {'measure': '28-day Mortality', 'timeFrame': 'From treatment initiation to Day 28', 'description': 'Number of deaths'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adaptive Design', 'At Risk', 'H1N1', 'Synergy', 'TCAD'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '12517228', 'type': 'BACKGROUND', 'citation': 'Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86. doi: 10.1001/jama.289.2.179.'}, {'pmid': '16494718', 'type': 'BACKGROUND', 'citation': 'Monto AS. Vaccines and antiviral drugs in pandemic preparedness. Emerg Infect Dis. 2006 Jan;12(1):55-60. doi: 10.3201/eid1201.051068.'}, {'pmid': '16371626', 'type': 'BACKGROUND', 'citation': 'Moscona A. Oseltamivir resistance--disabling our influenza defenses. N Engl J Med. 2005 Dec 22;353(25):2633-6. doi: 10.1056/NEJMp058291. No abstract available.'}, {'pmid': '28958678', 'type': 'DERIVED', 'citation': 'Beigel JH, Bao Y, Beeler J, Manosuthi W, Slandzicki A, Dar SM, Panuto J, Beasley RL, Perez-Patrigeon S, Suwanpimolkul G, Losso MH, McClure N, Bozzolo DR, Myers C, Holley HP Jr, Hoopes J, Lane HC, Hughes MD, Davey RT; IRC003 Study Team. Oseltamivir, amantadine, and ribavirin combination antiviral therapy versus oseltamivir monotherapy for the treatment of influenza: a multicentre, double-blind, randomised phase 2 trial. Lancet Infect Dis. 2017 Dec;17(12):1255-1265. doi: 10.1016/S1473-3099(17)30476-0. Epub 2017 Sep 22.'}], 'seeAlsoLinks': [{'url': 'http://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2010-I-0210.html', 'label': 'NIH Clinical Center Detailed Web Page'}, {'url': 'https://rsc.tech-res.com/clinical-research-sites/safety-reporting/daids-grading-tables', 'label': 'The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009).'}]}, 'descriptionModule': {'briefSummary': 'Seasonal influenza is responsible for many hospitalizations and deaths each year, despite effective antiviral treatments. Some individuals have medical conditions such as heart or lung diseases that make them particularly at risk of severe influenza infections that may result in hospitalization or death. Oseltamivir (Tamiflu) is used most often to treat flu, but there are still many hospitalizations, complications, and deaths even with treatment. This study evaluated the use of combination antivirals (amantadine, oseltamivir, and ribavirin) compared to oseltamivir alone in the treatment of influenza in an at-risk population.', 'detailedDescription': 'Seasonal influenza is responsible for approximately 226,000 excess hospitalizations annually and despite effective antivirals causes significant morbidity and mortality (estimated 24,000-50,000 deaths each year in the United States alone). The influenza virus that emerged in 2009 (A/California/07/2009 H1N1) caused fewer deaths (12,000 flu-related deaths in the U.S) but in contrast to seasonal flu, nearly 90 percent of the deaths with the 2009 H1N1 occurred among people younger than 65 years of age. The CDC has defined an at-risk population that accounts for the majority of hospitalization and morbidity associated with influenza. This study evaluated the use of combination antivirals as compared to oseltamivir alone in the treatment of influenza in an at-risk population.\n\nSubjects who met the CDC definition for being at-risk and that present with an influenza-like illness were screened for the study. Those subjects with a confirmatory test for influenza (rapid antigen or PCR) were randomized in a 1:1 manner to receive a blinded study treatment consisting of either the combination of amantadine, oseltamivir, and ribavirin or oseltamivir alone for 5 days. Clinical, virologic, and laboratory assessments on Days 1, 3, 7, 14, and 28 were used for both safety and efficacy analysis.\n\nDesign:\n\n* Participants were screened with a physical examination and medical history, along with blood tests and throat swabs to confirm influenza infection.\n* Eligible participants were randomly assigned to take either oseltamivir alone (the current standard treatment for influenza) or to take oseltamivir, amantadine, and ribavirin. Participants had additional blood samples and throat swabs taken at the start of the study, and were shown how to complete a study diary at home.\n* Participants received a study medication kit containing the medication to take at home twice a day for 5 days.\n* Participants returned, with the medication kit, to the clinic on days 1 (the first day after the start of the study), 3, 7, 14, and 28. The first visit took 2 to 3 hours, but each subsequent visit took approximately 1 to 2 hours. Additional blood samples and throat swabs were taken at these visits.\n\nPilot study:\n\nDue to the lack of reliable data concerning the AUC virologic endpoint, an "external" pilot study was conducted in the first 47 patients randomized to identify a primary endpoint and method of analysis, and to possibly modify the sample size. To ensure no effect on the type I error rate, data from these 47 patients were excluded from the primary and secondary efficacy analyses but were used in other analyses of secondary objectives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nEnrollment (Screening)\n\n1. Signed informed consent prior to initiation of any study procedures\n2. Presence of an underlying medical condition(s) that might increase risk of complications from influenza\n3. History of an influenza-like illness defined as:\n\n * One or more respiratory symptom (cough, sore throat, or nasal symptoms) AND\n * Either\n * Fever (subjective or documented \\>38 degrees C) OR\n * 1 or more constitutional symptom (headache, malaise, myalgia, sweats/chills or fatigue)\n4. Onset of illness no more than 96 hours before screening defined as when the subject experienced at least one respiratory symptom, constitutional symptom, or fever\n5. Willingness to have samples stored\n\nRandomization\n\n1. Signed informed consent\n2. Presence of a medical condition(s) that had been associated with increased risk of complications from influenza\n\n * Age 65 years of age or older\n * Asthma\n * Neurological and neuro-developmental conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle such as cerebral palsy, epilepsy \\[seizure disorders\\], stroke, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury) \\[though still able to provide informed consent per inclusion criteria #1\\]\n * Chronic lung disease (such as COPD and cystic fibrosis)\n * Heart disease (such as congenital heart disease, congestive heart failure, and coronary artery disease)\n * Blood disorders (excluding genetic causes of anemia, as noted in the exclusion criteria)\n * Endocrine disorders (such as diabetes mellitus)\n * Kidney disorders\n * Liver disorders\n * Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)\n * Weakened immune system due to disease or medication (such as people with HIV/AIDS, or cancer, chronic steroids or other medications causing immune suppression)\n * BMI ≥ 40(kg/m²)\n3. Onset of illness no more than 96 hours before screening defined as when the subject experienced at least one respiratory symptom, constitutional symptom, or fever\n4. Positive test for influenza (either rapid antigen or PCR)\n\n \\- Results from influenza testing obtained for clinical indications within 12 hours before screening/enrollment may be used if available. Randomization may proceed in cases of discrepant results (one positive and one negative)\n5. One of the following to avoid pregnancy:\n\n * Females who were able to become pregnant (i.e., are not postmenopausal, have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 2 effective forms of contraception from the date of informed consent through 6 months after the last dose of study drug. At least one of the methods of contraception should be a barrier method\n * Males who had not undergone surgical sterilization and are sexually active with women must agree to use condoms plus have a partner use at least one additional effective form of contraception from the date of informed consent through 6 months after the last dose of study drug\n6. Willingness to have samples stored\n\nEXCLUSION CRITERIA:\n\n(for Enrollment or Randomization)\n\n1. Women who were pregnant or breast-feeding, and men whose female partner(s) was pregnant\n2. Inability to take oral medication or a history of gastrointestinal malabsorption that would preclude the use of oral medication.\n3. Hemoglobin \\< 10 g/dL\n4. WBC \\< 1.5 times 10(9)/L\n5. Neutrophils \\< 0.75 x 10(9)/L\n6. Platelets \\< 50 x 10(9)/L\n7. History of genetic hemoglobinopathy (e.g., thalassemia major or sickle cell anemia) or autoimmune hemolytic anemia\n8. Received more than 2 doses of any antiviral influenza medications since onset of influenza symptoms\n9. Received stavudine (d4T), didanosine (ddI), zidovudine (AZT), or azathioprine within 30 days prior to study entry\n10. Creatinine clearance less than 60 mL/min (estimated by the Cockcroft-Gault equation using serum creatinine)\n11. History of autoimmune hepatitis\n12. Uncompensated liver disease (defined as AST \\> 3 times site upper limit of normal (ULN), ALT \\> 3 times ULN, or Direct Bilirubin \\> 2 times ULN)\n13. Clinical signs of end-stage liver disease including jaundice, coagulopathy, portal hypertension, esophageal varices, ascites, peripheral edema, gastrointestinal bleeding, or encephalopathy\n14. Chronic liver disease categorized as Child-Pugh class C (Child-Pugh score 10-15)\n15. Known hypersensitivity to rimantadine, amantadine, ribavirin, oseltamivir, peramivir, or zanamivir\n16. Received live attenuated virus vaccine (influenza or other) within 3 weeks prior to study entry\n17. Use of any investigational drug within 30 days or 5 half-lives (whichever was longer) prior to study entry\n18. Participation in other research protocols that would require more than 100 mL of blood to be drawn in any 4-week period that overlaps with this study.'}, 'identificationModule': {'nctId': 'NCT01227967', 'acronym': 'IRC003', 'briefTitle': 'Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) Versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications', 'orgStudyIdInfo': {'id': '10-I-0210'}, 'secondaryIdInfos': [{'id': '10-I-0210'}, {'id': 'IRC003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination Therapy', 'description': 'Amantadine, Ribavirin, Oseltamivir', 'interventionNames': ['Drug: Amantadine, Ribavirin, Oseltamivir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oseltamivir monotherapy', 'description': 'Oseltamivir', 'interventionNames': ['Drug: Oseltamivir']}], 'interventions': [{'name': 'Amantadine, Ribavirin, Oseltamivir', 'type': 'DRUG', 'description': 'Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.', 'armGroupLabels': ['Combination Therapy']}, {'name': 'Oseltamivir', 'type': 'DRUG', 'description': 'Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.', 'armGroupLabels': ['Oseltamivir monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Simon Williamson Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'East Valley Family Physicians', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Thomas Lenzmeier Family Practice', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Central Phoenix Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'WCCT Global LLC', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '92843', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Rx Clinical Research', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90717', 'city': 'Lomita', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Clinical Research Institute, Inc.', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91360', 'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Westlake Medical Research (CA)', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles BioMedical Research Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Empire Clinical Research', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Centennial - IMMUNOe International Research', 'geoPoint': {'lat': 39.57916, 'lon': -104.87692}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Best Quality Research Inc.', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33015', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'San Marcus Research Clinic, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Medical Consulting Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Research Group, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33782', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'DMI Research, Inc.', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Sneeze, Wheeze & Itch Associates, LLC', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '51503', 'city': 'Council Bluffs', 'state': 'Iowa', 'country': 'United States', 'facility': 'Ridge Family Practice', 'geoPoint': {'lat': 41.26194, 'lon': -95.86083}}, {'zip': '52246', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '42303', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Integrity, LLC', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '70535', 'city': 'Eunice', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Horizon Research Group, of Opelousas, LLC', 'geoPoint': {'lat': 30.49437, 'lon': -92.41763}}, {'zip': '70601', 'city': 'Lake Charles', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Centex Studies Inc. - Dr. Seep', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'NIH Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health Systems', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bronson Methodist Hospital', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '63044', 'city': 'Bridgeton', 'state': 'Missouri', 'country': 'United States', 'facility': 'West Florissant Internists', 'geoPoint': {'lat': 38.767, 'lon': -90.41151}}, {'zip': '68022', 'city': 'Elkhorn', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Clinical Research Advantage/ Skyline Medical Center', 'geoPoint': {'lat': 41.345, 'lon': -96.256}}, {'zip': '68025', 'city': 'Fremont', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Prairie Fields Family Medicine', 'geoPoint': {'lat': 41.43333, 'lon': -96.49808}}, {'zip': '68124', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Southwest Family Physicians', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Medical School', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'James J. Peters, VA Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina-Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Research Solutions - Dr. Panuto', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15478', 'city': 'Smithfield', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Montgomery Medical', 'geoPoint': {'lat': 39.80313, 'lon': -79.80783}}, {'zip': '57702', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Health Concepts', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '38401', 'city': 'Columbia', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Research Solutions - Dr. Bart', 'geoPoint': {'lat': 35.61507, 'lon': -87.03528}}, {'zip': '37064', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Research Solutions - Dr. Slandzicki', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Research Solutions - Dr. Hoppers', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Holston Medical Group', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '37211', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Research Solutions - Dr. Rowe', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37167', 'city': 'Smyrna', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Research Solutions - Dr. Dar', 'geoPoint': {'lat': 35.98284, 'lon': -86.5186}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Tech Amarillo', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '75010', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'facility': 'Family Medicine Associates of Texas', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'zip': '78413', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': '3rd Coast Research Associates', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77062', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Centex Studies Inc. - Dr. Pouzar', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77098', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Pioneer Research Solutions, Inc.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79430', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech HSC', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '78577', 'city': 'Pharr', 'state': 'Texas', 'country': 'United States', 'facility': 'Centex Studies Inc. - Dr. Garcia', 'geoPoint': {'lat': 26.1948, 'lon': -98.18362}}, {'zip': '75024', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Village Health Partners', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Endeavor Clinical Trials', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78249', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Bandera Family Healthcare Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'city': 'La Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto Medico Platense', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'city': 'Vicente López', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Houssay', 'geoPoint': {'lat': -34.52947, 'lon': -58.4737}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro de Educación Médica e Investigaciónes Clínicas (CEMIC)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundación del Centro de Estudios Infectológicos (FUNCEI)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital General de Agudos J. M. Ramos Mejía', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Hospital Rawson', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Santa Fe', 'country': 'Argentina', 'facility': 'Instituto Centralizado de Asistencia e Investigación Clínica Integral (CAICI)', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Holdsworth House Med Practice', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Taylor Square Private Clinic', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Royal Brisbane', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '3068', 'city': 'Fitzroy North', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Northside Clinic', 'geoPoint': {'lat': -37.78862, 'lon': 144.97885}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'México', 'country': 'Mexico', 'facility': 'Instituto Nacional de Ciencias Médicas y Nutrición (INCMN) Salvador Zubirán', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Tlalpan', 'country': 'Mexico', 'facility': 'Hospital General y de Alta Especialidad "Dr. Manuel GEA Gonzalez"', 'geoPoint': {'lat': 19.29513, 'lon': -99.16206}}, {'city': 'Tlalpan', 'country': 'Mexico', 'facility': 'Instituto Nacional de Enfermedades Respiratorias (INER)', 'geoPoint': {'lat': 19.29513, 'lon': -99.16206}}, {'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital, Mahidol University'}, {'zip': '10330', 'city': 'Patumwan', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'HIV-NAT, The Thai Red Cross AIDS'}, {'zip': '40002', 'city': 'Muang', 'state': 'Changwat Khon Kaen', 'country': 'Thailand', 'facility': 'Srinagarind Hospital, Khon Kaen University'}, {'zip': '11000', 'city': 'Muang', 'state': 'Changwat Nonthaburi', 'country': 'Thailand', 'facility': 'Bamrasnaradura Infectious Diseases Institute'}], 'overallOfficials': [{'name': 'John Beigel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Leidos Biomedical Research, Inc. in support of Clinical Research Section, LIR, NIAID, Natinal Institutes of Health'}, {'name': 'John Treanor, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}