Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-31 @ 7:55 AM
Study NCT ID:
NCT02369159
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2015-02-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
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': 'C414210', 'term': 'peramivir'}, {'id': 'D053139', 'term': 'Oseltamivir'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biocryst.com', 'phone': '+1 919-859-1302', 'title': 'Study Director', 'organization': 'BioCryst Pharmaceuticals Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs were recorded on Day 1, Day 3, Day 7 and Day 14/Early Withdraw visit.', 'description': 'Adverse events were graded through use of the Division of Acquired Immune Deficiency Syndrome (DAIDS) Tables for Grading Adult and Pediatric Adverse Experiences. Influenza-related complications were not considered AEs unless they met the criteria for an SAE.', 'eventGroups': [{'id': 'EG000', 'title': 'Peramivir', 'description': 'Age-appropriate single dose Peramivir, administered as a single short iv infusion:\n\nSubjects ≥12 years - 600 mg. Subjects \\<12 years - 12 mg/kg (max. 600 mg). Subjects \\< 6 months - 8 mg/kg.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 22, 'seriousNumAtRisk': 107, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Oseltamivir', 'description': 'Age appropriate oral dose of Oseltamivir BID for 5 days:\n\nSubjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \\< 13 years - weight-based dose as a capsule or oral suspension.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 5, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Tympanic membrane hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Elevated aspartate aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Elevated blood lactate dehydrogenase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Injection site coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Injection site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Tonsillar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Tympanic membrane disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Carbon dioxide decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peramivir', 'description': 'Age-appropriate single dose Peramivir, administered as a single short iv infusion:\n\nSubjects ≥12 years - 600 mg. Subjects \\<12 years - 12 mg/kg (max. 600 mg). Subjects \\< 6 months - 8 mg/kg.'}, {'id': 'OG001', 'title': 'Oseltamivir', 'description': 'Age appropriate oral dose of Oseltamivir BID for 5 days:\n\nSubjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \\< 13 years - weight-based dose as a capsule or oral suspension.'}], 'classes': [{'title': 'Adverse Event', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Severe or life-threatening Adverse Event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adverse Event possibly, probably, or definitely related to study drug', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Adverse Event leading to discontinuation from study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Adverse Event leading to Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'Safety evaluation included assessment of Adverse Events (AEs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all randomized subjects who received ≥ 1 partial dose of peramivir or oseltamivir.'}, {'type': 'SECONDARY', 'title': 'Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Peramivir (≥ 28 Days - < 2 Years)', 'description': 'Age-appropriate dose Peramivir, administered as a single short iv infusion:\n\nSubjects \\<2 years - 12 mg/kg (max. 600 mg). Subjects \\< 6 months - 8 mg/kg.'}, {'id': 'OG001', 'title': 'Peramivir (≥ 2 - < 7 Years)', 'description': '12 mg/kg (max. 600 mg) dose Peramivir, administered as a single short iv infusion'}, {'id': 'OG002', 'title': 'Peramivir (≥ 7 - < 13 Years)', 'description': 'Age-appropriate dose Peramivir, administered as a single short iv infusion:\n\nSubjects ≥12 years - 600 mg. Subjects \\<12 years - 12 mg/kg (max. 600 mg).'}, {'id': 'OG003', 'title': 'Peramivir (≥ 13 - < 18 Years)', 'description': '600 mg dose Peramivir, administered as a single short iv infusion'}], 'classes': [{'title': 'AUC0-last', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56200', 'spread': '21430', 'groupId': 'OG000'}, {'value': '71200', 'spread': '31380', 'groupId': 'OG001'}, {'value': '87000', 'spread': '40750', 'groupId': 'OG002'}, {'value': '72400', 'spread': '19970', 'groupId': 'OG003'}]}]}, {'title': 'AUC0-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '53300', 'spread': '19100', 'groupId': 'OG000'}, {'value': '68100', 'spread': '27060', 'groupId': 'OG001'}, {'value': '81400', 'spread': '35090', 'groupId': 'OG002'}, {'value': '68300', 'spread': '19190', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 6 hours post peramivir infusion', 'description': 'Up to 4 blood samples will be drawn, where possible: immediately following infusion and 30 to 60 mins, 1 to 3 hrs and 4 to 6 hrs post-infusions. AUC calculations were performed in Phoenix WinNonlin using the linear/log trapezoidal rule. AUC0-last was calculated between start of the infusion and the time of the last measurable concentration.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITTI) population included all randomized subjects. Of these 114 subjects, 106 had sufficient PK samples collected for inclusion in the peramivir PK analysis'}, {'type': 'SECONDARY', 'title': 'Time to Resolution of Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Peramivir (≥ 28 Days - < 2 Years)', 'description': 'Age-appropriate dose Peramivir, administered as a single short iv infusion:\n\nSubjects \\<2 years - 12 mg/kg (max. 600 mg). Subjects \\< 6 months - 8 mg/kg.'}, {'id': 'OG001', 'title': 'Oseltamivir (≥ 28 Days - < 2 Years)', 'description': 'Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.'}, {'id': 'OG002', 'title': 'Peramivir (≥ 2 - < 7 Years)', 'description': '12 mg/kg (max. 600 mg) dose Peramivir, administered as a single short iv infusion'}, {'id': 'OG003', 'title': 'Oseltamivir (≥ 2 - < 7 Years)', 'description': 'Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.'}, {'id': 'OG004', 'title': 'Peramivir (≥ 7 - < 13 Years)', 'description': 'Age-appropriate dose Peramivir, administered as a single short iv infusion:\n\nSubjects ≥12 years - 600 mg. Subjects \\<12 years - 12 mg/kg (max. 600 mg).'}, {'id': 'OG005', 'title': 'Oseltamivir (≥ 7 - < 13 Years)', 'description': 'Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.'}, {'id': 'OG006', 'title': 'Peramivir (≥ 13 - < 18 Years)', 'description': '600 mg dose Peramivir, administered as a single short iv infusion'}, {'id': 'OG007', 'title': 'Oseltamivir (≥ 13 - < 18 Years)', 'description': '75mg dose of Oseltamivir as a capsule or oral suspension BID for 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'spread': '6.55', 'groupId': 'OG000'}, {'value': '61.8', 'spread': 'NA', 'comment': 'Only one participant in group', 'groupId': 'OG001'}, {'value': '58.8', 'spread': '8.42', 'groupId': 'OG002'}, {'value': '16.0', 'spread': '2.38', 'groupId': 'OG003'}, {'value': '36.3', 'spread': '5.00', 'groupId': 'OG004'}, {'value': '29.7', 'spread': '7.82', 'groupId': 'OG005'}, {'value': '51.3', 'spread': '11.59', 'groupId': 'OG006'}, {'value': '43.9', 'spread': '13.67', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'Time for fever resolution based on subject diary record of temperature recorded twice daily. A subject had resolution of fever if he/she had oral temperature of \\< 99.4°F or an axillary temperature of \\< 98.4°F and no antipyretic medications were taken for ≥ 12 hours. The time to resolution of fever was estimated for each age group and overall using the Kaplan-Meier method with temperature and symptom relief medication information obtained from the Subject Diary data.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Intent to treat infected (ITTI) population. Subjects who did not have resolution of fever were censored at the time of their last non-missing post-baseline temperature assessment; this included 1 subject in the '≥ 28 days - \\< 2 years' cohort treated with Peramivir. Seventeen subjects were excluded from summaries due to missing data or events resolving prior to initiation of study drug."}, {'type': 'SECONDARY', 'title': 'Time to Resolution of Influenza Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Peramivir (≥ 28 Days - < 2 Years)', 'description': 'Age-appropriate dose Peramivir, administered as a single short iv infusion:\n\nSubjects \\<2 years - 12 mg/kg (max. 600 mg). Subjects \\< 6 months - 8 mg/kg.'}, {'id': 'OG001', 'title': 'Oseltamivir (≥ 28 Days - < 2 Years)', 'description': 'Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.'}, {'id': 'OG002', 'title': 'Peramivir (≥ 2 - < 7 Years)', 'description': '12 mg/kg (max. 600 mg) dose Peramivir, administered as a single short iv infusion'}, {'id': 'OG003', 'title': 'Oseltamivir (≥ 2 - < 7 Years)', 'description': 'Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.'}, {'id': 'OG004', 'title': 'Peramivir (≥ 7 - < 13 Years)', 'description': 'Age-appropriate dose Peramivir, administered as a single short iv infusion:\n\nSubjects ≥12 years - 600 mg. Subjects \\<12 years - 12 mg/kg (max. 600 mg).'}, {'id': 'OG005', 'title': 'Oseltamivir (≥ 7 - < 13 Years)', 'description': 'Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.'}, {'id': 'OG006', 'title': 'Peramivir (≥ 13 - < 18 Years)', 'description': '600 mg dose Peramivir, administered as a single short iv infusion'}, {'id': 'OG007', 'title': 'Oseltamivir (≥ 13 - < 18 Years)', 'description': '75mg dose of Oseltamivir as a capsule or oral suspension BID for 5 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.1', 'spread': '19.77', 'groupId': 'OG000'}, {'value': '98.9', 'spread': 'NA', 'comment': 'Only one participant in group', 'groupId': 'OG001'}, {'value': '94.1', 'spread': '11.53', 'groupId': 'OG002'}, {'value': '20.7', 'spread': '2.32', 'groupId': 'OG003'}, {'value': '66.6', 'spread': '7.83', 'groupId': 'OG004'}, {'value': '134.4', 'spread': '15.74', 'groupId': 'OG005'}, {'value': '101.3', 'spread': '18.46', 'groupId': 'OG006'}, {'value': '75.5', 'spread': '12.76', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'description': 'Subjects or parents or caregivers were asked to provide an assessment of age-appropriate influenza symptoms on a 4-point severity scale (0,absent; 1, mild; 2, moderate; 3, severe) twice daily beginning before screening on Day 1 until symptoms resolved or until the last follow-up visit. Time to alleviation of symptoms was the number of hours from initiation of study drug until the start of the time period in which all age-appropriate symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 - 10%) hours. Subjects who did not experience alleviation of symptoms were censored at the last observed symptom assessment.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Intent to treat infected (ITTI) population. Subjects with no alleviation of symptoms were censored at date of last post-baseline assessment; including 1 subject in the '≥ 28 days to \\< 2 yrs, Peramivir' group, 1 subject in the '≥ 2 to \\< 7 yrs, Peramivir' group, 4 subjects in the '≥ 7 to \\< 13 yrs, Peramivir' group and 1 subject each in the '≥ 13 to \\< 18 yrs' Peramivir and Oseltamivir groups. Seven subjects were excluded due to missing data or events resolving prior to initiation of study drug."}, {'type': 'SECONDARY', 'title': 'Time to Reduction in Viral Shedding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Peramivir (≥ 28 Days - < 2 Years)', 'description': 'Age-appropriate dose Peramivir, administered as a single short iv infusion:\n\nSubjects \\<2 years - 12 mg/kg (max. 600 mg). Subjects \\< 6 months - 8 mg/kg.'}, {'id': 'OG001', 'title': 'Oseltamivir (≥ 28 Days - < 2 Years)', 'description': 'Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.'}, {'id': 'OG002', 'title': 'Peramivir (≥ 2 - < 7 Years)', 'description': '12 mg/kg (max. 600 mg) dose Peramivir, administered as a single short iv infusion'}, {'id': 'OG003', 'title': 'Oseltamivir (≥ 2 - < 7 Years)', 'description': 'Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.'}, {'id': 'OG004', 'title': 'Peramivir (≥ 7 - < 13 Years)', 'description': 'Age-appropriate dose Peramivir, administered as a single short iv infusion:\n\nSubjects ≥12 years - 600 mg. Subjects \\<12 years - 12 mg/kg (max. 600 mg).'}, {'id': 'OG005', 'title': 'Oseltamivir (≥ 7 - < 13 Years)', 'description': 'Weight-based dose of Oseltamivir as a capsule or oral suspension BID for 5 days.'}, {'id': 'OG006', 'title': 'Peramivir (≥ 13 - < 18 Years)', 'description': '600 mg dose Peramivir, administered as a single short iv infusion'}, {'id': 'OG007', 'title': 'Oseltamivir (≥ 13 - < 18 Years)', 'description': '75mg dose of Oseltamivir as a capsule or oral suspension BID for 5 days.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days', 'description': 'Assessment of viral shedding in bilateral, mid-nasal swab specimens taken at baseline and then on Day 3, 7 and 14.', 'unitOfMeasure': 'participants with positive viral titer', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat infected (ITTI) population + ITT population with positive baseline influenza viral titers \\[\\> 0.5 log10 TCID50/mL\\]; a total of 84 subjects.'}, {'type': 'SECONDARY', 'title': 'Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peramivir', 'description': 'Age-appropriate single dose Peramivir, administered as a single short iv infusion:\n\nSubjects ≥12 years - 600 mg. Subjects \\<12 years - 12 mg/kg (max. 600 mg). Subjects \\< 6 months - 8 mg/kg.'}, {'id': 'OG001', 'title': 'Oseltamivir', 'description': 'Age appropriate oral dose of Oseltamivir BID for 5 days:\n\nSubjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \\< 13 years - weight-based dose as a capsule or oral suspension.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.38', 'groupId': 'OG000', 'lowerLimit': '0.75', 'upperLimit': '6.50'}, {'value': '4.50', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '5.75'}]}]}, {'title': 'Day 3 - Change rom baseline', 'categories': [{'measurements': [{'value': '-2.75', 'groupId': 'OG000', 'lowerLimit': '-6.00', 'upperLimit': '2.50'}, {'value': '-3.25', 'groupId': 'OG001', 'lowerLimit': '-5.00', 'upperLimit': '1.25'}]}]}, {'title': 'Day 7 - Change from baseline', 'categories': [{'measurements': [{'value': '-3.75', 'groupId': 'OG000', 'lowerLimit': '-6.00', 'upperLimit': '1.00'}, {'value': '-4.00', 'groupId': 'OG001', 'lowerLimit': '-5.25', 'upperLimit': '-1.00'}]}]}, {'title': 'Day 14 - Change from baseline', 'categories': [{'measurements': [{'value': '-3.75', 'groupId': 'OG000', 'lowerLimit': '-6.00', 'upperLimit': '-0.25'}, {'value': '-4.00', 'groupId': 'OG001', 'lowerLimit': '-5.25', 'upperLimit': '-1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from baseline assessed on days 3, 7 and 14.', 'description': 'Change in influenza viral titers was defined as the time-weighted change from Baseline in log\\_10 tissue culture infective dose\\_50 (TCID50/mL) and was summarized for each treatment group.', 'unitOfMeasure': 'influenza viral titer - log10 TCID50/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent To Treat Infected (ITTI) population included all subjects who were enrolled, received study drug, and had confirmed influenza A and/or B by PCR. Thirteen subjects were excluded due to a negative or missing baseline titer.'}, {'type': 'SECONDARY', 'title': 'Influenza-Related Complications Assessment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peramivir', 'description': 'Age-appropriate single dose Peramivir, administered as a single short iv infusion:\n\nSubjects ≥12 years - 600 mg. Subjects \\<12 years - 12 mg/kg (max. 600 mg). Subjects \\< 6 months - 8 mg/kg.'}, {'id': 'OG001', 'title': 'Oseltamivir', 'description': 'Age appropriate oral dose of Oseltamivir BID for 5 days:\n\nSubjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \\< 13 years - weight-based dose as a capsule or oral suspension.'}], 'classes': [{'title': 'Otitis', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sinusitis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bronchitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'The investigator performed a full physical exam at baseline. At each follow-up visit, study personnel evaluated the subject for the presence of clinical signs and symptoms of the following influenza-related complications: sinusitis, otitis media, bronchitis, and pneumonia requiring antibiotic use, diagnosed after initiation of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat infected (ITTI) population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peramivir', 'description': 'Age-appropriate dose Peramivir, administered as a single short iv infusion:\n\nSubjects ≥12 years - 600 mg. Subjects \\<12 years - 12 mg/kg (max. 600 mg). Subjects \\< 6 months - 8 mg/kg.'}, {'id': 'FG001', 'title': 'Oseltamivir', 'description': 'Age appropriate oral dose of Oseltamivir BID for 5 days:\n\nSubjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \\< 13 years - weight-based dose as a capsule or oral suspension.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'ITT Population', 'comment': 'Intend-to-treat (ITT) population included all randomized subjects', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Safety Population', 'comment': 'Safety Population included all randomized subjects who received ≥ 1 partial dose of peramivir or oseltamivir.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'ITTI Population', 'comment': 'Intent-to-treat-infected (ITTI) population included all subjects who were enrolled, treated, and had influenza confirmed by RT-PCR.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'E-R Population', 'comment': 'Exposure-response (E-R) Population included all subjects in the ITTI population who had a quantifiable peramivir concentration on Day 1 and had ≥ 1 post-baseline effectiveness assessment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'comment': 'Milestone only applied to Peramivir group', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Peramivir', 'description': 'Age-appropriate single dose Peramivir, administered as a single short iv infusion:\n\nSubjects ≥12 years - 600 mg. Subjects \\<12 years - 12 mg/kg (max. 600 mg). Subjects \\< 6 months - 8 mg/kg.'}, {'id': 'BG001', 'title': 'Oseltamivir', 'description': 'Age appropriate oral dose of Oseltamivir BID for 5 days:\n\nSubjects ≥ 13 years - 75mg dose as a capsule or oral suspension. Subjects \\< 13 years - weight-based dose as a capsule or oral suspension.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '5.07', 'groupId': 'BG000'}, {'value': '9.9', 'spread': '4.99', 'groupId': 'BG001'}, {'value': '8.4', 'spread': '5.09', 'groupId': 'BG002'}]}]}, {'title': '≥ 28 days to < 2-year-old cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.47', 'groupId': 'BG000'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Only 1 participant in group', 'groupId': 'BG001'}, {'value': '1.3', 'spread': '0.47', 'groupId': 'BG002'}]}]}, {'title': '≥ 2 to < 7-year-old cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '1.47', 'groupId': 'BG000'}, {'value': '4.7', 'spread': '1.60', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '1.47', 'groupId': 'BG002'}]}]}, {'title': '≥ 7 to < 13-year-old cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.6', 'spread': '1.75', 'groupId': 'BG000'}, {'value': '9.7', 'spread': '1.92', 'groupId': 'BG001'}, {'value': '9.6', 'spread': '1.76', 'groupId': 'BG002'}]}]}, {'title': '≥ 13 to < 18-year-old cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15.7', 'spread': '1.45', 'groupId': 'BG000'}, {'value': '15.9', 'spread': '1.50', 'groupId': 'BG001'}, {'value': '15.7', 'spread': '1.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Age at time of randomisation - years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Mean age (SD) is reported for the overall ITT population and for each of the 4 age groups'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Influenza Viral Titer', 'classes': [{'title': 'Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}, {'title': 'Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-to-Treat (ITTI) population included all randomized subjects and was the primary population for analyses of demography and subject accountability.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-05', 'size': 1581254, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-12T04:35', 'hasProtocol': True}, {'date': '2016-07-11', 'size': 618660, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-12T04:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-26', 'studyFirstSubmitDate': '2015-02-17', 'resultsFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2015-02-17', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-26', 'studyFirstPostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.', 'timeFrame': '14 days', 'description': 'Safety evaluation included assessment of Adverse Events (AEs).'}], 'secondaryOutcomes': [{'measure': 'Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose', 'timeFrame': 'up to 6 hours post peramivir infusion', 'description': 'Up to 4 blood samples will be drawn, where possible: immediately following infusion and 30 to 60 mins, 1 to 3 hrs and 4 to 6 hrs post-infusions. AUC calculations were performed in Phoenix WinNonlin using the linear/log trapezoidal rule. AUC0-last was calculated between start of the infusion and the time of the last measurable concentration.'}, {'measure': 'Time to Resolution of Fever', 'timeFrame': '14 days', 'description': 'Time for fever resolution based on subject diary record of temperature recorded twice daily. A subject had resolution of fever if he/she had oral temperature of \\< 99.4°F or an axillary temperature of \\< 98.4°F and no antipyretic medications were taken for ≥ 12 hours. The time to resolution of fever was estimated for each age group and overall using the Kaplan-Meier method with temperature and symptom relief medication information obtained from the Subject Diary data.'}, {'measure': 'Time to Resolution of Influenza Symptoms', 'timeFrame': '14 days', 'description': 'Subjects or parents or caregivers were asked to provide an assessment of age-appropriate influenza symptoms on a 4-point severity scale (0,absent; 1, mild; 2, moderate; 3, severe) twice daily beginning before screening on Day 1 until symptoms resolved or until the last follow-up visit. Time to alleviation of symptoms was the number of hours from initiation of study drug until the start of the time period in which all age-appropriate symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 - 10%) hours. Subjects who did not experience alleviation of symptoms were censored at the last observed symptom assessment.'}, {'measure': 'Time to Reduction in Viral Shedding', 'timeFrame': '14 days', 'description': 'Assessment of viral shedding in bilateral, mid-nasal swab specimens taken at baseline and then on Day 3, 7 and 14.'}, {'measure': 'Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.', 'timeFrame': 'Change from baseline assessed on days 3, 7 and 14.', 'description': 'Change in influenza viral titers was defined as the time-weighted change from Baseline in log\\_10 tissue culture infective dose\\_50 (TCID50/mL) and was summarized for each treatment group.'}, {'measure': 'Influenza-Related Complications Assessment.', 'timeFrame': '14 days', 'description': 'The investigator performed a full physical exam at baseline. At each follow-up visit, study personnel evaluated the subject for the presence of clinical signs and symptoms of the following influenza-related complications: sinusitis, otitis media, bronchitis, and pneumonia requiring antibiotic use, diagnosed after initiation of treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of pediatric subjects with acute uncomplicated influenza.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '0 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Clinical signs and symptoms consistent with acute influenza infection consisting of an oral temperature ≥ 100°F (37.8°C) or rectal temperature ≥ 101.3ºF (≥ 38.5ºC) with at least one respiratory symptom (cough or rhinitis) OR Positive influenza determined by PCR or Rapid Antigen Test\n2. Onset of symptoms no more than 72 hours before presentation for screening for subjects \\< 2 years old.\n\nKey Exclusion Criteria:\n\n1. Pregnant or breast-feeding females\n2. Development of symptoms while hospitalized\n3. Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications\n4. Presence of immunocompromised status'}, 'identificationModule': {'nctId': 'NCT02369159', 'briefTitle': 'Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioCryst Pharmaceuticals'}, 'officialTitle': 'A Phase 3, Randomized, Open Label, Active-controlled Study to Evaluate the Safety, Pharmacokinetics and Effectiveness of IV Peramivir Compared to Oral Oseltamivir in Pediatric Subjects With Acute Uncomplicated Influenza', 'orgStudyIdInfo': {'id': 'BCX1812-305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peramivir (IV)', 'description': 'Subjects randomized to peramivir will receive an age appropriate single dose, diluted to a maximum volume of 100 mL in normal saline, administered as a short intravenous infusion over a minimum of 15 minutes.\n\n* Subjects ≥12 years will receive a dose of 600 mg.\n* Subjects \\<12 years will receive a dose of 12 mg/kg (to a maximum dose of 600 mg).\n* Subjects \\< 6 months will receive a dose of 8 mg/kg.', 'interventionNames': ['Drug: Peramivir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oseltamivir', 'description': 'Subjects randomized to oral oseltamivir will receive an age appropriate dose twice daily for 5 days.\n\n* Subjects ≥ 13 years will receive a 75mg dose administered as a capsule or oral suspension (twice daily for 5 days).\n* Subjects \\< 13 years of age will receive a weight-based dose administered as a capsule or oral suspension (twice daily for 5 days).', 'interventionNames': ['Drug: Oseltamivir']}], 'interventions': [{'name': 'Peramivir', 'type': 'DRUG', 'armGroupLabels': ['Peramivir (IV)']}, {'name': 'Oseltamivir', 'type': 'DRUG', 'armGroupLabels': ['Oseltamivir']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Peramivir Investigative Site', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Peramivir investigative site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'city': 'Smithfield', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Peramivir investigative site', 'geoPoint': {'lat': 39.80313, 'lon': -79.80783}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Peramivir Investigative Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Peramivir investigative site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Splendora', 'state': 'Texas', 'country': 'United States', 'facility': 'Peramivir investigative site', 'geoPoint': {'lat': 30.23299, 'lon': -95.16104}}, {'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'Peramivir investigative site', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Peramivir investigative site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Peramivir investigative site', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}, {'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Peramivir Investigative Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}], 'overallOfficials': [{'name': 'John Vanchiere, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief, Pediatric Infectious Diseases, Louisiana State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioCryst Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}