Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 6:17 PM
Study NCT ID:
NCT01716234
Status:
TERMINATED
Last Update Posted:
2018-08-27
First Post:
2012-10-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Germany', 'Greece', 'Netherlands', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009181', 'term': 'Mycoses'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C101425', 'term': 'posaconazole'}, {'id': 'C494814', 'term': 'BID protein, human'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to proprietary information, accuracy, fair balance, and compliance.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Only 1 participant was enrolled in the POS 12 TID 3 months to \\<2 years group, limiting conclusions that may be drawn for pharmacokinetics or safety.'}}, 'adverseEventsModule': {'timeFrame': 'All AEs: from Day 1 up to Day 39; SAEs: up to Day 58.', 'description': 'The population analyzed is all treated participants.', 'eventGroups': [{'id': 'EG000', 'title': 'POS 12 BID 2 to <7 Yrs', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.', 'otherNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'POS 12 BID 7 to <18 Yrs', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.', 'otherNumAtRisk': 21, 'otherNumAffected': 20, 'seriousNumAtRisk': 21, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'POS 18 BID 2 to <7 Yrs', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.', 'otherNumAtRisk': 19, 'otherNumAffected': 16, 'seriousNumAtRisk': 19, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'POS 18 BID 7 to <18 Yrs', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.', 'otherNumAtRisk': 28, 'otherNumAffected': 26, 'seriousNumAtRisk': 28, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'POS 18 TID 2 to <7 Yrs', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.', 'otherNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'seriousNumAffected': 7}, {'id': 'EG005', 'title': 'POS 18 TID 7 to <18 Yrs', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.', 'otherNumAtRisk': 30, 'otherNumAffected': 28, 'seriousNumAtRisk': 30, 'seriousNumAffected': 11}, {'id': 'EG006', 'title': 'POS 12 TID 3 Months to <2 Yrs', 'description': 'Participants aged 3 months to \\<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 11, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 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'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 19, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 22, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Antithrombin III deficiency', 'stats': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 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{'groupId': 'EG005', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'POS 12 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG001', 'title': 'POS 12 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG002', 'title': 'POS 18 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG003', 'title': 'POS 18 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG004', 'title': 'POS 18 TID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG005', 'title': 'POS 18 TID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG006', 'title': 'POS 12 TID 3 Months to <2 Years', 'description': 'Participants aged 3 months to \\<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'spread': '101', 'groupId': 'OG000'}, {'value': '107', 'spread': '92.5', 'groupId': 'OG001'}, {'value': '112', 'spread': '86.9', 'groupId': 'OG002'}, {'value': '113', 'spread': '100', 'groupId': 'OG003'}, {'value': '68.4', 'spread': '40.4', 'groupId': 'OG004'}, {'value': '57.9', 'spread': '30.2', 'groupId': 'OG005'}, {'value': '68.5', 'spread': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)', 'description': 'Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to \\<2 years of age weighing \\<6.5 kg.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.'}, {'type': 'PRIMARY', 'title': 'Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'POS 12 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG001', 'title': 'POS 12 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG002', 'title': 'POS 18 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG003', 'title': 'POS 18 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG004', 'title': 'POS 18 TID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG005', 'title': 'POS 18 TID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG006', 'title': 'POS 12 TID 3 Months to <2 Years', 'description': 'Participants aged 3 months to \\<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '604', 'spread': '779', 'groupId': 'OG000'}, {'value': '1050', 'spread': '789', 'groupId': 'OG001'}, {'value': '485', 'spread': '306', 'groupId': 'OG002'}, {'value': '1240', 'spread': '1400', 'groupId': 'OG003'}, {'value': '620', 'spread': '411', 'groupId': 'OG004'}, {'value': '1150', 'spread': '750', 'groupId': 'OG005'}, {'value': '453', 'spread': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose', 'description': 'Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to \\<2500 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'POS 12 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG001', 'title': 'POS 12 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG002', 'title': 'POS 18 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG003', 'title': 'POS 18 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG004', 'title': 'POS 18 TID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG005', 'title': 'POS 18 TID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG006', 'title': 'POS 12 TID 3 Months to <2 Years', 'description': 'Participants aged 3 months to \\<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 58', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was all treated participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Adverse Event Leading to Study Drug Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'POS 12 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG001', 'title': 'POS 12 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG002', 'title': 'POS 18 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG003', 'title': 'POS 18 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG004', 'title': 'POS 18 TID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG005', 'title': 'POS 18 TID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}, {'id': 'OG006', 'title': 'POS 12 TID 3 Months to <2 Years', 'description': 'Participants aged 3 months to \\<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 28', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was all treated participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'POS 12 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'FG001', 'title': 'POS 12 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'FG002', 'title': 'POS 18 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'FG003', 'title': 'POS 18 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'FG004', 'title': 'POS 18 TID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}, {'id': 'FG005', 'title': 'POS 18 TID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}, {'id': 'FG006', 'title': 'POS 12 TID 3 Months to <2 Years', 'description': 'Participants aged 3 months to \\<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '32'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '30'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '18'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Did not meet protocol eligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 160 participants were screened, 142 were randomized / enrolled, and 136 were treated. An arm planned for participants aged 3 months to \\<2 years to receive posaconazole 18 mg/kg/day TID was never initiated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '142', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'POS 12 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'BG001', 'title': 'POS 12 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'BG002', 'title': 'POS 18 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'BG003', 'title': 'POS 18 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.'}, {'id': 'BG004', 'title': 'POS 18 TID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}, {'id': 'BG005', 'title': 'POS 18 TID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}, {'id': 'BG006', 'title': 'POS 12 TID 3 Months to <2 Years', 'description': 'Participants aged 3 months to \\<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '1.3', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '11.9', 'spread': '3.5', 'groupId': 'BG001', 'lowerLimit': '7', 'upperLimit': '17'}, {'value': '4.4', 'spread': '1.5', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '12.2', 'spread': '3.2', 'groupId': 'BG003', 'lowerLimit': '7', 'upperLimit': '18'}, {'value': '4.1', 'spread': '1.3', 'groupId': 'BG004', 'lowerLimit': '3', 'upperLimit': '7'}, {'value': '13.1', 'spread': '3.0', 'groupId': 'BG005', 'lowerLimit': '7', 'upperLimit': '18'}, {'value': '0.9', 'spread': '0', 'groupId': 'BG006', 'lowerLimit': '1', 'upperLimit': '1'}, {'value': '8.9', 'spread': '4.9', 'groupId': 'BG007', 'lowerLimit': '1', 'upperLimit': '18'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '59', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '83', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'whyStopped': 'Study was terminated early (10 July 2015) based on preliminary analysis of pharmacokinetic data.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-27', 'studyFirstSubmitDate': '2012-10-25', 'resultsFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2012-10-25', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-15', 'studyFirstPostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)', 'timeFrame': 'Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)', 'description': 'Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to \\<2 years of age weighing \\<6.5 kg.'}, {'measure': 'Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)', 'timeFrame': 'Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose', 'description': 'Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to \\<2500 ng/mL.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With an Adverse Event', 'timeFrame': 'Up to Day 58', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.'}, {'measure': 'Number of Participants With an Adverse Event Leading to Study Drug Discontinuation', 'timeFrame': 'Up to Day 28', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Fungal Infections']}, 'referencesModule': {'references': [{'pmid': '30913226', 'type': 'DERIVED', 'citation': 'Arrieta AC, Sung L, Bradley JS, Zwaan CM, Gates D, Waskin H, Carmelitano P, Groll AH, Lehrnbecher T, Mangin E, Joshi A, Kartsonis NA, Walsh TJ, Paschke A. A non-randomized trial to assess the safety, tolerability, and pharmacokinetics of posaconazole oral suspension in immunocompromised children with neutropenia. PLoS One. 2019 Mar 26;14(3):e0212837. doi: 10.1371/journal.pone.0212837. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documented or anticipated neutropenia expected to last at least 7 days and only in the following clinical situations: acute leukemia; myelodysplasia; severe aplastic anemia; autologous hematopoietic stem cell transplantation (HSCT) recipients; high risk neuroblastoma; advanced stage non-Hodgkin's lymphoma; recipients of allogeneic HSCT during the pre-engraftment (neutropenia) period\n* Participants of child-bearing potential must use a medically accepted method of\n\ncontraception throughout the study and for at least 30 days after stopping study medication, unless they are surgically or medically sterile or agree to remain abstinent.\n\nExclusion Criteria:\n\n* Proven invasive fungal infection (IFI) before study entry\n* Severe nausea and/or vomiting at screening\n* Received posaconazole within 10 days before screening\n* Unable to receive study drug by mouth or via an intestinal (enteral) tube\n* Females who are pregnant, intend to become pregnant during the study, or are breastfeeding\n* History of anaphylaxis attributed to the azole class of antifungal agents"}, 'identificationModule': {'nctId': 'NCT01716234', 'briefTitle': 'A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia (P03579)', 'orgStudyIdInfo': {'id': 'P03579'}, 'secondaryIdInfos': [{'id': '2007-004645-15', 'type': 'EUDRACT_NUMBER'}, {'id': 'MK-5592-032', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'POS 12 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.', 'interventionNames': ['Drug: Posaconazole 12 mg/kg/day BID']}, {'type': 'EXPERIMENTAL', 'label': 'POS 12 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.', 'interventionNames': ['Drug: Posaconazole 12 mg/kg/day BID']}, {'type': 'EXPERIMENTAL', 'label': 'POS 18 BID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.', 'interventionNames': ['Drug: Posaconazole 18 mg/kg/day BID']}, {'type': 'EXPERIMENTAL', 'label': 'POS 18 BID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.', 'interventionNames': ['Drug: Posaconazole 18 mg/kg/day BID']}, {'type': 'EXPERIMENTAL', 'label': 'POS 18 TID 2 to <7 Years', 'description': 'Participants aged 2 to \\<7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.', 'interventionNames': ['Drug: Posaconazole 18 mg/kg/day TID']}, {'type': 'EXPERIMENTAL', 'label': 'POS 18 TID 7 to <18 Years', 'description': 'Participants aged 7 to \\<18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.', 'interventionNames': ['Drug: Posaconazole 18 mg/kg/day TID']}, {'type': 'EXPERIMENTAL', 'label': 'POS 12 TID 3 months to <2 Years', 'description': 'Participants aged 3 months to \\<2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.', 'interventionNames': ['Drug: Posaconazole 12 mg/kg/day TID']}], 'interventions': [{'name': 'Posaconazole 12 mg/kg/day BID', 'type': 'DRUG', 'otherNames': ['SCH 056592', 'MK-5592', 'Noxafil®'], 'description': 'Posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) (maximum 800 mg/day)', 'armGroupLabels': ['POS 12 BID 2 to <7 Years', 'POS 12 BID 7 to <18 Years']}, {'name': 'Posaconazole 18 mg/kg/day BID', 'type': 'DRUG', 'otherNames': ['SCH 056592', 'MK-5592', 'Noxafil®'], 'description': 'Posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) (maximum 1200 mg/day)', 'armGroupLabels': ['POS 18 BID 2 to <7 Years', 'POS 18 BID 7 to <18 Years']}, {'name': 'Posaconazole 18 mg/kg/day TID', 'type': 'DRUG', 'otherNames': ['SCH 056592', 'MK-5592', 'Noxafil®'], 'description': 'Posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) (maximum 1200 mg/day)', 'armGroupLabels': ['POS 18 TID 2 to <7 Years', 'POS 18 TID 7 to <18 Years']}, {'name': 'Posaconazole 12 mg/kg/day TID', 'type': 'DRUG', 'otherNames': ['SCH 056592', 'MK-5592', 'Noxafil®'], 'description': 'Posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) (maximum 800 mg/day)', 'armGroupLabels': ['POS 12 TID 3 months to <2 Years']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}