Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-29 @ 6:04 AM
Study NCT ID:
NCT01033734
Status:
COMPLETED
Last Update Posted:
2016-08-24
First Post:
2009-12-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Intravenous Tamiflu (Oseltamivir) in Children With 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': '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': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Low number of participants enrolled in the study at the time that the study was terminated limits conclusions that can be derived from the study data.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Oseltamivir: Overall', 'description': "Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \\<= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.", 'otherNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \\<=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight \\>40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.", 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \\<=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.", 'otherNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \\<=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.", 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Left Ventricular Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Catheter Site Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Device Expulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Drug Withdrawal Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Infusion Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Body Temperature Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ingrowing Nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pain of Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Oseltamivir', 'categories': [{'measurements': [{'value': '829', 'groupId': 'OG000'}, {'value': '1460', 'spread': '46.3', 'groupId': 'OG001'}]}]}, {'title': 'Oseltamivir Carboxylate', 'categories': [{'measurements': [{'value': '1700', 'groupId': 'OG000'}, {'value': '4550', 'spread': '61.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.', 'unitOfMeasure': 'hour*nanogram/milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population included all treated participants who had at least one blood sample evaluable for drug concentration level. Number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Oseltamivir', 'categories': [{'measurements': [{'value': '1070', 'groupId': 'OG001'}, {'value': '1920', 'groupId': 'OG002'}]}]}, {'title': 'Oseltamivir Carboxylate', 'categories': [{'measurements': [{'value': '5970', 'groupId': 'OG001'}, {'value': '6760', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Oseltamivir', 'categories': [{'measurements': [{'value': '943', 'groupId': 'OG000'}]}]}, {'title': 'Oseltamivir Carboxylate', 'categories': [{'measurements': [{'value': '2000', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Oseltamivir', 'categories': [{'measurements': [{'value': '2480', 'groupId': 'OG001'}]}]}, {'title': 'Oseltamivir Carboxylate', 'categories': [{'measurements': [{'value': '3800', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Oseltamivir', 'categories': [{'measurements': [{'value': '1010', 'groupId': 'OG000'}]}]}, {'title': 'Oseltamivir Carboxylate', 'categories': [{'measurements': [{'value': '2820', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Oseltamivir', 'categories': [{'measurements': [{'value': '360', 'groupId': 'OG000'}, {'value': '753', 'spread': '36.9', 'groupId': 'OG001'}]}]}, {'title': 'Oseltamivir Carboxylate', 'categories': [{'measurements': [{'value': '311', 'groupId': 'OG000'}, {'value': '499', 'spread': '55.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion', 'unitOfMeasure': 'nanograms/milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Oseltamivir', 'categories': [{'measurements': [{'value': '500', 'groupId': 'OG001'}, {'value': '1270', 'groupId': 'OG002'}]}]}, {'title': 'Oseltamivir Carboxylate', 'categories': [{'measurements': [{'value': '663', 'groupId': 'OG001'}, {'value': '725', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Oseltamivir', 'categories': [{'measurements': [{'value': '404', 'groupId': 'OG000'}]}]}, {'title': 'Oseltamivir Carboxylate', 'categories': [{'measurements': [{'value': '237', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Oseltamivir', 'categories': [{'measurements': [{'value': '915', 'groupId': 'OG001'}]}]}, {'title': 'Oseltamivir Carboxylate', 'categories': [{'measurements': [{'value': '549', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'PRIMARY', 'title': 'Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Oseltamivir', 'categories': [{'measurements': [{'value': '403', 'groupId': 'OG000'}]}]}, {'title': 'Oseltamivir Carboxylate', 'categories': [{'measurements': [{'value': '408', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Number of participants analyzed = participants who were evaluable for this outcome.'}, {'type': 'SECONDARY', 'title': 'Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Day 1: Oseltamivir (n = 1, 3, 0)', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '41.7', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG002'}]}]}, {'title': 'Day 1: Oseltamivir Carboxylate (n = 1, 3, 0)', 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000'}, {'value': '4.61', 'spread': '53.3', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG002'}]}]}, {'title': 'Day 2: Oseltamivir (n = 0, 1, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG000'}, {'value': '2.00', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG001'}, {'value': '1.00', 'groupId': 'OG002'}]}]}, {'title': 'Day 2: Oseltamivir Carboxylate (n = 0, 1, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG000'}, {'value': '4.62', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG001'}, {'value': '6.00', 'groupId': 'OG002'}]}]}, {'title': 'Day 3: Oseltamivir (n = 1, 0, 0)', 'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG002'}]}]}, {'title': 'Day 3: Oseltamivir Carboxylate (n = 1, 0, 0)', 'categories': [{'measurements': [{'value': '3.05', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG002'}]}]}, {'title': 'Day 4: Oseltamivir (n = 0, 1, 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG000'}, {'value': '2.50', 'spread': 'NA', 'comment': 'Standard deviation not applicable as only 1 participant was evaluable', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG002'}]}]}, {'title': 'Day 4: Oseltamivir Carboxylate (n = 0, 1, 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG000'}, {'value': '8.05', 'spread': 'NA', 'comment': 'Standard deviation not applicable as only 1 participant was evaluable', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG002'}]}]}, {'title': 'Day 5: Oseltamivir (n = 1, 0, 0)', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG002'}]}]}, {'title': 'Day 5: Oseltamivir Carboxylate (n = 1, 0, 0)', 'categories': [{'measurements': [{'value': '4.08', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.'}, {'type': 'SECONDARY', 'title': 'Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Day 1: Oseltamivir (n = 1, 3, 0)', 'categories': [{'measurements': [{'value': '4.40', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '80.6', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 1: Oseltamivir Carboxylate (n = 1, 3, 0)', 'categories': [{'measurements': [{'value': '237', 'groupId': 'OG000'}, {'value': '308', 'spread': '74.4', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 2: Oseltamivir (n = 0, 2, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '25.2', 'spread': '1704911.2', 'groupId': 'OG001'}, {'value': '4.76', 'groupId': 'OG002'}]}]}, {'title': 'Day 2: Oseltamivir Carboxylate (n = 0, 2, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '319', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '484', 'groupId': 'OG002'}]}]}, {'title': 'Day 3: Oseltamivir (n = 1, 0, 0)', 'categories': [{'measurements': [{'value': '2.60', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 3: Oseltamivir Carboxylate (n = 1, 0, 0)', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 4: Oseltamivir (n = 0, 1, 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '25.1', 'spread': 'NA', 'comment': 'Standard deviation not applicable as only 1 participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 4: Oseltamivir Carboxylate (n = 0, 1, 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '549', 'spread': 'NA', 'comment': 'Standard deviation not applicable as only 1 participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 5: Oseltamivir (n = 1, 0, 0)', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 5: Oseltamivir Carboxylate (n = 1, 0, 0)', 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.'}, {'type': 'SECONDARY', 'title': 'Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Day 1: Oseltamivir (n = 1, 3, 0)', 'categories': [{'measurements': [{'value': '7.42', 'groupId': 'OG000'}, {'value': '10.50', 'spread': '23.4', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 1: Oseltamivir Carboxylate (n = 1, 3, 0)', 'categories': [{'measurements': [{'value': '7.42', 'groupId': 'OG000'}, {'value': '11.98', 'spread': '0.2', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 2: Oseltamivir (n = 0, 2, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '448.5', 'groupId': 'OG001'}, {'value': '12.00', 'groupId': 'OG002'}]}]}, {'title': 'Day 2: Oseltamivir Carboxylate (n = 0, 2, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '448.47', 'groupId': 'OG001'}, {'value': '12.00', 'groupId': 'OG002'}]}]}, {'title': 'Day 3: Oseltamivir (n = 1, 0, 0)', 'categories': [{'measurements': [{'value': '10.13', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 3: Oseltamivir Carboxylate (n = 1, 0, 0)', 'categories': [{'measurements': [{'value': '10.13', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 4: Oseltamivir (n = 0, 1, 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '8.05', 'spread': 'NA', 'comment': 'Standard deviation not applicable as only 1 participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 4: Oseltamivir Carboxylate (n = 0, 1, 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG000'}, {'value': '8.05', 'spread': 'NA', 'comment': 'Standard deviation not applicable as only 1 participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 5: Oseltamivir (n = 1, 0, 0)', 'categories': [{'measurements': [{'value': '7.92', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}, {'title': 'Day 5: Oseltamivir Carboxylate (n = 1, 0, 0)', 'categories': [{'measurements': [{'value': '7.92', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data not available as no participant was evaluable.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population. Number of participants analyzed = participants who were evaluable for this outcome, n = number of participants evaluable for specified categories.'}, {'type': 'SECONDARY', 'title': 'Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: Overall', 'description': "Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \\<= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not available as no participant was evaluable for specified time-points.'}, {'type': 'SECONDARY', 'title': 'Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: Overall', 'description': "Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \\<= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not available as no participant was evaluable for specified time-points.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: Overall', 'description': "Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \\<= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected because of changes in planned analysis, due to early study termination.'}, {'type': 'SECONDARY', 'title': 'Participants With Greater Than or Equal to (>=) 5-Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oseltamivir: Overall', 'description': "Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \\<= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG001', 'title': 'Oseltamivir: 6 to 12 Years', 'description': "Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \\<=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight \\>40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG002', 'title': 'Oseltamivir: 3 to 5 Years', 'description': "Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \\<=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}, {'id': 'OG003', 'title': 'Oseltamivir: 1 to 2 Years', 'description': "Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight \\<=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'classes': [{'title': 'Day 1 (n=6, 2, 3, 1)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 6 (n=1, 0, 1, 0)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data not available as no participant was evaluable in this arm for specified time-point.', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Data not available as no participant was evaluable in this arm for specified time-point.', 'groupId': 'OG003'}]}]}, {'title': 'Day 30 (n=1, 1, 0, 0)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Data not available as no participant was evaluable in this arm for specified time-point.', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'Data not available as no participant was evaluable in this arm for specified time-point.', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 1, 6 and 30', 'description': 'IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either \\>=5 times change in the NAI IC50 visit value from the Reference value at a visit, \\>=5 times change in the NAI IC50 Visit value from the Baseline value.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of IV study medication and had a safety assessment performed after initiation of treatment. Here, number of participants analyzed = participants evaluable for this outcome measure, and n = participants evaluable for specified time-point, for each arm, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oseltamivir: Overall', 'description': "Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight less than or equal to (≤) 23 kilogram (kg) received 3 milligrams per kilogram (mg/kg); participants with body weight more than (\\>) 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight \\>40 kg received 100 milligrams (mg). For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 2836 participants were prescreened, of which, 2828 failed evaluation. The most common reasons for screen failure included: negative influenza diagnosis, not meeting the age criterion, ability to tolerate/absorb oral medication, and an inability to comply with the study procedures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Oseltamivir: Overall', 'description': "Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant's body weight. Participants with body weight ≤23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '3.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All-participants population included all participants who were enrolled in the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-13', 'studyFirstSubmitDate': '2009-12-15', 'resultsFirstSubmitDate': '2016-01-15', 'studyFirstSubmitQcDate': '2009-12-15', 'lastUpdatePostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-13', 'studyFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1', 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion.'}, {'measure': 'AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2', 'timeFrame': 'Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}, {'measure': 'AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 3', 'timeFrame': 'Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}, {'measure': 'AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4', 'timeFrame': 'Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}, {'measure': 'AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 5', 'timeFrame': 'Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate Day 1', 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion'}, {'measure': 'Cmax of Oseltamivir and Oseltamivir Carboxylate Day 2', 'timeFrame': 'Day 2: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}, {'measure': 'Cmax of Oseltamivir and Oseltamivir Carboxylate Day 3', 'timeFrame': 'Day 3 (with or after fifth dose): 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}, {'measure': 'Cmax of Oseltamivir and Oseltamivir Carboxylate Day 4', 'timeFrame': 'Day 4: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}, {'measure': 'Cmax of Oseltamivir and Oseltamivir Carboxylate Day 5', 'timeFrame': 'Day 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}], 'secondaryOutcomes': [{'measure': 'Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate', 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}, {'measure': 'Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate', 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}, {'measure': 'Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate', 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}, {'measure': 'Elimination Rate Constant (ke) of Oseltamivir and Oseltamivir Carboxylate', 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}, {'measure': 'Total Clearance of Drug (CL) of Oseltamivir and Oseltamivir Carboxylate', 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}, {'measure': 'Volume of Distribution (V) of Oseltamivir and Oseltamivir Carboxylate', 'timeFrame': 'Day 1: 15 minutes pre-infusion start, 1, 2, 3, 4, 6, 8, 12 hours post start of infusion; Day 2, 3 (with or after fifth dose), 4 or 5: 15 minutes pre-infusion start, 2, 4, 8 hours after start of infusion'}, {'measure': 'Participants With Greater Than or Equal to (>=) 5-Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values', 'timeFrame': 'Baseline, Day 1, 6 and 30', 'description': 'IC50 was defined as the concentration that causes 50% inhibition of viral activity. IC50 values were calculated using NAI assay. The 5-fold change was calculated as either \\>=5 times change in the NAI IC50 visit value from the Reference value at a visit, \\>=5 times change in the NAI IC50 Visit value from the Baseline value.'}]}, 'conditionsModule': {'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '26042486', 'type': 'DERIVED', 'citation': 'Munoz FM, Anderson EJ, Deville JG, Clinch B, Kamal MA. Pharmacokinetics and safety of intravenous oseltamivir in infants and children in open-label studies. Int J Clin Pharmacol Ther. 2015 Jul;53(7):531-40. doi: 10.5414/CP202307.'}]}, 'descriptionModule': {'briefSummary': 'This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions no longer merit continued iv dosing, therapy may be switched to oral Tamiflu to complete their prescribed course of treatment. If medically necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days. Anticipated time on study treatment is 5 to 10 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children, 1-12 years of age\n* diagnosis of influenza\n* duration of influenza symptoms \\</=96 hours prior to first dose of study drug\n\nExclusion Criteria:\n\n* evidence of severe hepatic decompensation\n* patients taking probenecid within 1 week prior to first dose of study drug'}, 'identificationModule': {'nctId': 'NCT01033734', 'briefTitle': 'A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir (Tamiflu) in the Treatment of Children 1 to 12 Years of Age With Influenza Infection', 'orgStudyIdInfo': {'id': 'NP25139'}}, 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