Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT01383993
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2011-06-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001228', 'term': 'Aspergillosis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065819', 'term': 'Voriconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).', 'otherNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).', 'otherNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Histiocytosis haematophagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Colour blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chromatopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anorectal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Painful defaecation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'categories': [{'measurements': [{'value': '51.92', 'spread': '51', 'groupId': 'OG000'}, {'value': '83.39', 'spread': '56', 'groupId': 'OG001'}, {'value': '17.27', 'spread': '28', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion', 'description': 'AUC12,ss was obtained by the Linear/Log trapezoidal method.', 'unitOfMeasure': 'μg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.753', 'spread': '38', 'groupId': 'OG000'}, {'value': '9.233', 'spread': '55', 'groupId': 'OG001'}, {'value': '3.092', 'spread': '42', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.96', 'groupId': 'OG000', 'lowerLimit': '0.950', 'upperLimit': '4.00'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '2.92', 'upperLimit': '4.20'}, {'value': '1.34', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '1.67'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion', 'unitOfMeasure': 'hrs', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'categories': [{'measurements': [{'value': '48.23', 'spread': '83', 'groupId': 'OG000'}, {'value': '59.42', 'spread': '67', 'groupId': 'OG001'}, {'value': '10.00', 'spread': 'NA', 'comment': 'Number of analyzed participant was 1.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing', 'description': 'AUC12,ss was obtained by the Linear/Log trapezoidal method.', 'unitOfMeasure': 'μg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.755', 'spread': '50', 'groupId': 'OG000'}, {'value': '7.910', 'spread': '45', 'groupId': 'OG001'}, {'value': '2.030', 'spread': 'NA', 'comment': 'Number of analyzed participant was 1.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000', 'lowerLimit': '0.917', 'upperLimit': '3.78'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.950', 'upperLimit': '2.03'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing', 'unitOfMeasure': 'hrs', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Assessed Near Distance Visual Acuity Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Immunocompromised children aged 2 to \\<15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'The 7th day of IV treatment', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'The 1st day of oral treatment', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'The 7th day of oral treatment', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'The 30 day follow up visit', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis was performed on all subjects who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Assessed Color Vision Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Immunocompromised children aged 2 to \\<15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'The 7th day of IV treatment', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'The 1st day of oral treatment', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'The 7th day of oral treatment', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'The 30 day follow up visit', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis was performed on all subjects who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Assessed Visual Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Immunocompromised children aged 2 to \\<15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'The 7th day of IV treatment', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'The 1st day of oral treatment', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'The 7th day of oral treatment', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'The 30 day follow up visit', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis was performed on all subjects who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.077', 'spread': '0.547', 'groupId': 'OG000'}, {'value': '0.648', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '0.476', 'spread': 'NA', 'comment': 'Number of analyzed participant was 1.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'AUC12, ss for IV:Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion. AUC12,ss for oral: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing.', 'description': 'Ratio was calculated from the following formula; AUC12,ss Following Oral Administration over AUC12,ss Following IV Administration', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'categories': [{'measurements': [{'value': '66.50', 'spread': '30', 'groupId': 'OG000'}, {'value': '80.99', 'spread': '41', 'groupId': 'OG001'}, {'value': '40.00', 'spread': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion', 'description': 'AUC12,ss was obtained by the Linear/Log trapezoidal method.', 'unitOfMeasure': 'μg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.381', 'spread': '28', 'groupId': 'OG000'}, {'value': '8.066', 'spread': '34', 'groupId': 'OG001'}, {'value': '3.835', 'spread': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.05', 'groupId': 'OG000', 'lowerLimit': '2.87', 'upperLimit': '11.8'}, {'value': '4.49', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '11.1'}, {'value': '3.84', 'groupId': 'OG002', 'lowerLimit': '1.67', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion', 'unitOfMeasure': 'hrs', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'categories': [{'measurements': [{'value': '79.86', 'spread': '36', 'groupId': 'OG000'}, {'value': '90.84', 'spread': '19', 'groupId': 'OG001'}, {'value': '34.40', 'spread': 'NA', 'comment': 'Number of analyzed participant was 1.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing', 'description': 'AUC12,ss was obtained by the Linear/Log trapezoidal method.', 'unitOfMeasure': 'μg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.971', 'spread': '31', 'groupId': 'OG000'}, {'value': '8.912', 'spread': '22', 'groupId': 'OG001'}, {'value': '3.720', 'spread': 'NA', 'comment': 'Number of analyzed participant was 1.', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'OG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.07', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '7.78'}, {'value': '2.03', 'groupId': 'OG001', 'lowerLimit': '0.950', 'upperLimit': '4.00'}, {'value': '3.80', 'groupId': 'OG002', 'lowerLimit': '3.80', 'upperLimit': '3.80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing', 'unitOfMeasure': 'hrs', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'FG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'FG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Marketed voriconazole in post-therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants Aged 2 to <12 Years', 'description': 'Immunocompromised children aged 2 to \\<12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'BG001', 'title': 'Participants Aged 12 to<15 Years and Weighed <50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'BG002', 'title': 'Participants Aged 12 to<15 Years and Weighed ≥50 kg', 'description': 'Immunocompromised children aged 12 to \\<15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '12.5', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '14.0', 'spread': '0.0', 'groupId': 'BG002'}, {'value': '9.2', 'spread': '3.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-08', 'studyFirstSubmitDate': '2011-06-27', 'resultsFirstSubmitDate': '2014-04-07', 'studyFirstSubmitQcDate': '2011-06-27', 'lastUpdatePostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-08', 'studyFirstPostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration', 'timeFrame': 'Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion', 'description': 'AUC12,ss was obtained by the Linear/Log trapezoidal method.'}, {'measure': 'Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration', 'timeFrame': 'Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration', 'timeFrame': 'Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration', 'timeFrame': 'Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing', 'description': 'AUC12,ss was obtained by the Linear/Log trapezoidal method.'}, {'measure': 'Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration', 'timeFrame': 'Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration', 'timeFrame': 'Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing'}, {'measure': 'Number of Participants Assessed Near Distance Visual Acuity Test', 'timeFrame': 'Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit'}, {'measure': 'Number of Participants Assessed Color Vision Test', 'timeFrame': 'Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit'}, {'measure': 'Number of Participants Assessed Visual Questionnaire', 'timeFrame': 'Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit'}], 'secondaryOutcomes': [{'measure': 'Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration', 'timeFrame': 'AUC12, ss for IV:Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion. AUC12,ss for oral: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing.', 'description': 'Ratio was calculated from the following formula; AUC12,ss Following Oral Administration over AUC12,ss Following IV Administration'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration', 'timeFrame': 'Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion', 'description': 'AUC12,ss was obtained by the Linear/Log trapezoidal method.'}, {'measure': 'Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration', 'timeFrame': 'Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration', 'timeFrame': 'Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration', 'timeFrame': 'Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing', 'description': 'AUC12,ss was obtained by the Linear/Log trapezoidal method.'}, {'measure': 'Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration', 'timeFrame': 'Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration', 'timeFrame': 'Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Open-Label', 'Pharmacokinetics', 'Intravenous to oral switch', 'Safety', 'Voriconazole', 'Immunocompromise', 'Children', 'High Risk For Systemic Fungal Infection'], 'conditions': ['Aspergillosis, Aspergilloma']}, 'referencesModule': {'references': [{'pmid': '25451051', 'type': 'DERIVED', 'citation': 'Mori M, Kobayashi R, Kato K, Maeda N, Fukushima K, Goto H, Inoue M, Muto C, Okayama A, Watanabe K, Liu P. Pharmacokinetics and safety of voriconazole intravenous-to-oral switch regimens in immunocompromised Japanese pediatric patients. Antimicrob Agents Chemother. 2015 Feb;59(2):1004-13. doi: 10.1128/AAC.04093-14. Epub 2014 Dec 1.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501096&StudyName=Study%20Of%20The%20Pharmacokinetics%20And%20Safety%20Of%20Voriconazole%20In%20Children%202%20To%20Less%20Than%2015%20Years%20Old%20Who%20Are%20At%20High%20Risk%20For%20System', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to less than 15 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female from 2 to \\<15 years of age.\n* Require treatment for the prevention of systemic fungal infection.\n* Expected to develop neutropenia (ANC \\<500 cells/uL) lasting more than 10 days following chemotherapy.\n* Anticipated to live for more than 3 months.\n\nExclusion Criteria:\n\n* Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.\n* Documented bacterial or viral infection not responding to appropriate treatment.\n* Hypersensitivity to or severe intolerance of azole antifungal agents.\n* Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.'}, 'identificationModule': {'nctId': 'NCT01383993', 'briefTitle': 'Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open-Label, Non-Controlled, Multicenter, Intravenous To Oral Switch, Phase 2 Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Children Aged 2 To Less Than 15 Years Who Are At High Risk For Systemic Fungal Infection', 'orgStudyIdInfo': {'id': 'A1501096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1.0', 'description': 'Immunocompromised children aged 2 to \\<15 and 12 to \\<15 years weighing \\<50 kg who are at high risk for systemic fungal infection.', 'interventionNames': ['Drug: Voriconazole']}, {'type': 'EXPERIMENTAL', 'label': '2.0', 'description': 'Immunocompromised children aged 12 to \\<15 years weighing more than 50 kg who are at high risk for systemic fungal infection.', 'interventionNames': ['Drug: Voriconazole']}], 'interventions': [{'name': 'Voriconazole', 'type': 'DRUG', 'otherNames': ['UK-109,496; Vfend; Voriconazole'], 'description': 'Study Days 1: IV voriconazole 9 mg/kg q12h. Study Days 2 to 7: IV voriconazole 8 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 9 mg/kg q12h with a maximum of 350 mg q12 h.\n\nNotes:\n\nIf unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.\n\nOnly morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.\n\n(IV = Intravenous; POS = Powder for oral suspension)', 'armGroupLabels': ['1.0']}, {'name': 'Voriconazole', 'type': 'DRUG', 'otherNames': ['UK-109,496; Vfend; Voriconazole'], 'description': 'Study Days 1: IV voriconazole 6 mg/kg q12h. Study Days 2 to 7: IV voriconazole 4 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h.\n\nNotes:\n\nIf unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.\n\nOnly morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.\n\n(IV = Intravenous; POS = Powder for oral suspension)', 'armGroupLabels': ['2.0']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Japanese Red Cross Nagoya Daiichi Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'National hospital Organization Nagoya Medical Center', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Sapporo Hokuyu Hosipital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': "Kanagawa Children's Medical Center", 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Izumi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Medical Center and Research Institute for Maternal and Child Health', 'geoPoint': {'lat': 34.48333, 'lon': 135.43333}}, {'city': 'Shimotsuga-gun', 'state': 'Tochigi', 'country': 'Japan', 'facility': 'Dokkyo Medical University Hospital'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}