Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT00818259
Status:
TERMINATED
Last Update Posted:
2018-09-25
First Post:
2009-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Brazil', 'Canada', 'Colombia', 'France', 'Germany', 'Hungary', 'Israel', 'Mexico', 'Norway', 'Peru', 'Poland', 'Spain', 'Sweden', 'Switzerland', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077608', 'term': 'Aprepitant'}, {'id': 'C579707', 'term': 'fosaprepitant'}, {'id': 'D017294', 'term': 'Ondansetron'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, '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 sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 days after last dose of study drug (Up to 17 days)', 'description': 'The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.', 'eventGroups': [{'id': 'EG000', 'title': 'Part IA-fosaprepitant 115 mg/Aprepitant', 'description': 'Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.', 'otherNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Part IB-fosaprepitant 150 mg', 'description': 'Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.', 'otherNumAtRisk': 11, 'otherNumAffected': 5, 'seriousNumAtRisk': 11, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Part IIA-aprepitant 80 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \\<12 years of age - 47 mg/m\\^2; 4 months to \\<6 months of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.', 'otherNumAtRisk': 19, 'otherNumAffected': 18, 'seriousNumAtRisk': 19, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Part IIB-aprepitant 125 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \\<12 years of age - 74 mg/m\\^2; 6 months to \\<2 years of age - 1.3 mg/kg; 4 months to \\<6 months of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; birth to \\<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.', 'otherNumAtRisk': 19, 'otherNumAffected': 15, 'seriousNumAtRisk': 19, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Part III-ondansetron', 'description': 'Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \\<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.', 'otherNumAtRisk': 19, 'otherNumAffected': 15, 'seriousNumAtRisk': 19, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'Part IV-aprepitant Regimen', 'description': 'Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.', 'otherNumAtRisk': 20, 'otherNumAffected': 13, 'seriousNumAtRisk': 20, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Part V-fosaprepitant Regimen', 'description': 'Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.', 'otherNumAtRisk': 23, 'otherNumAffected': 16, 'seriousNumAtRisk': 23, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 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'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Catheter site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Enterobacter bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vulval abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part IA-fosaprepitant 115 mg/Aprepitant', 'description': 'Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG001', 'title': 'Part IB-fosaprepitant 150 mg', 'description': 'Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG002', 'title': 'Part IIA-aprepitant 80 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \\<12 years of age - 47 mg/m\\^2; 4 months to \\<6 months of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG003', 'title': 'Part IIB-aprepitant 125 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \\<12 years of age - 74 mg/m\\^2; 6 months to \\<2 years of age - 1.3 mg/kg; 4 months to \\<6 months of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; birth to \\<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG004', 'title': 'Part III-ondansetron', 'description': 'Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \\<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG005', 'title': 'Part IV-aprepitant Regimen', 'description': 'Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG006', 'title': 'Part V-fosaprepitant Regimen', 'description': 'Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}], 'classes': [{'title': '6 months to <2 years (n=0, 0, 5, 5, 0, 6, 6)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '20000', 'spread': '7890', 'groupId': 'OG002'}, {'value': '6310', 'spread': '2040', 'groupId': 'OG003'}, {'value': '21100', 'spread': '11800', 'groupId': 'OG005'}, {'value': '11700', 'spread': '6980', 'groupId': 'OG006'}]}]}, {'title': '2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '16400', 'spread': '8080', 'groupId': 'OG002'}, {'value': '23000', 'spread': '8390', 'groupId': 'OG003'}, {'value': '17300', 'spread': '5060', 'groupId': 'OG005'}, {'value': '18300', 'spread': '11100', 'groupId': 'OG006'}]}]}, {'title': '6 years to <12 years (n=0, 0, 6, 6, 0, 6, 8)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '16000', 'spread': '4810', 'groupId': 'OG002'}, {'value': '22000', 'spread': '9440', 'groupId': 'OG003'}, {'value': '24400', 'spread': '15800', 'groupId': 'OG005'}, {'value': '19500', 'spread': '6720', 'groupId': 'OG006'}]}]}, {'title': '12 years to 17 years (n=8, 11, 0, 0, 0, 0, 0)', 'categories': [{'measurements': [{'value': '19500', 'spread': '8010', 'groupId': 'OG000'}, {'value': '30800', 'spread': '7020', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 hours post fosaprepitant/aprepitant dose', 'description': 'AUC is a measure of the amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for pharmacokinetic (PK) assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hours (hr) post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) for Aprepitant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part IA-fosaprepitant 115 mg/Aprepitant', 'description': 'Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG001', 'title': 'Part IB-fosaprepitant 150 mg', 'description': 'Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG002', 'title': 'Part IIA-aprepitant 80 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \\<12 years of age - 47 mg/m\\^2; 4 months to \\<6 months of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG003', 'title': 'Part IIB-aprepitant 125 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \\<12 years of age - 74 mg/m\\^2; 6 months to \\<2 years of age - 1.3 mg/kg; 4 months to \\<6 months of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; birth to \\<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG004', 'title': 'Part III-ondansetron', 'description': 'Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \\<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG005', 'title': 'Part IV-aprepitant Regimen', 'description': 'Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG006', 'title': 'Part V-fosaprepitant Regimen', 'description': 'Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}], 'classes': [{'title': '6 months to <2 years (n=0, 0, 5, 5, 0, 6, 7)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '1930', 'spread': '1000', 'groupId': 'OG002'}, {'value': '659', 'spread': '107', 'groupId': 'OG003'}, {'value': '1810', 'spread': '925', 'groupId': 'OG005'}, {'value': '1700', 'spread': '636', 'groupId': 'OG006'}]}]}, {'title': '2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '1300', 'spread': '609', 'groupId': 'OG002'}, {'value': '2100', 'spread': '1170', 'groupId': 'OG003'}, {'value': '1840', 'spread': '933', 'groupId': 'OG005'}, {'value': '2430', 'spread': '1100', 'groupId': 'OG006'}]}]}, {'title': '6 years to <12 years (n=0, 0, 6, 6, 0, 7, 8)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '1300', 'spread': '275', 'groupId': 'OG002'}, {'value': '1930', 'spread': '873', 'groupId': 'OG003'}, {'value': '1800', 'spread': '1610', 'groupId': 'OG005'}, {'value': '2850', 'spread': '641', 'groupId': 'OG006'}]}]}, {'title': '12 years to 17 years (n=12, 11, 0, 0, 0, 0, 0)', 'categories': [{'measurements': [{'value': '3240', 'spread': '1280', 'groupId': 'OG000'}, {'value': '5870', 'spread': '2770', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 72 hours post fosaprepitant/aprepitant dose', 'description': 'Cmax is a measure of the maximum amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.'}, {'type': 'PRIMARY', 'title': 'Time to Cmax (Tmax) for Aprepitant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part IA-fosaprepitant 115 mg/Aprepitant', 'description': 'Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG001', 'title': 'Part IB-fosaprepitant 150 mg', 'description': 'Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG002', 'title': 'Part IIA-aprepitant 80 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \\<12 years of age - 47 mg/m\\^2; 4 months to \\<6 months of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG003', 'title': 'Part IIB-aprepitant 125 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \\<12 years of age - 74 mg/m\\^2; 6 months to \\<2 years of age - 1.3 mg/kg; 4 months to \\<6 months of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; birth to \\<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG004', 'title': 'Part III-ondansetron', 'description': 'Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \\<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG005', 'title': 'Part IV-aprepitant Regimen', 'description': 'Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG006', 'title': 'Part V-fosaprepitant Regimen', 'description': 'Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}], 'classes': [{'title': '6 months to <2 years (n=0, 0, 5, 5, 0, 6, 7)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '2.33', 'spread': '1.16', 'groupId': 'OG002'}, {'value': '3.45', 'spread': '2.89', 'groupId': 'OG003'}, {'value': '7.34', 'spread': '8.28', 'groupId': 'OG005'}, {'value': '1.13', 'spread': '0.17', 'groupId': 'OG006'}]}]}, {'title': '2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '3.78', 'spread': '1.92', 'groupId': 'OG002'}, {'value': '5.28', 'spread': '1.97', 'groupId': 'OG003'}, {'value': '4.92', 'spread': '2.20', 'groupId': 'OG005'}, {'value': '1.41', 'spread': '0.83', 'groupId': 'OG006'}]}]}, {'title': '6 years to <12 years (n=0, 0, 6, 6, 0, 7, 8)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '5.17', 'spread': '1.83', 'groupId': 'OG002'}, {'value': '3.08', 'spread': '0.95', 'groupId': 'OG003'}, {'value': '6.42', 'spread': '7.84', 'groupId': 'OG005'}, {'value': '1.07', 'spread': '0.11', 'groupId': 'OG006'}]}]}, {'title': '12 years to 17 years (n=12, 11, 0, 0, 0, 0, 0)', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.30', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 72 hours post fosaprepitant/aprepitant dose', 'description': 'Tmax is a measure of the amount of time after dosing to when the maximum concentration of aprepitant was achieved. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Half-life (t1/2) for Aprepitant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part IA-fosaprepitant 115 mg/Aprepitant', 'description': 'Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG001', 'title': 'Part IB-fosaprepitant 150 mg', 'description': 'Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG002', 'title': 'Part IIA-aprepitant 80 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \\<12 years of age - 47 mg/m\\^2; 4 months to \\<6 months of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG003', 'title': 'Part IIB-aprepitant 125 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \\<12 years of age - 74 mg/m\\^2; 6 months to \\<2 years of age - 1.3 mg/kg; 4 months to \\<6 months of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; birth to \\<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG004', 'title': 'Part III-ondansetron', 'description': 'Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \\<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG005', 'title': 'Part IV-aprepitant Regimen', 'description': 'Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG006', 'title': 'Part V-fosaprepitant Regimen', 'description': 'Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}], 'classes': [{'title': '6 months to <2 years (n=0, 0, 5, 3, 0, 3, 6)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '7.28', 'spread': '1.47', 'groupId': 'OG002'}, {'value': '8.09', 'spread': '2.54', 'groupId': 'OG003'}, {'value': '6.18', 'spread': '4.12', 'groupId': 'OG005'}, {'value': '7.71', 'spread': '3.10', 'groupId': 'OG006'}]}]}, {'title': '2 years to <6 years (n=0, 0, 6, 4, 0, 5, 7)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '8.27', 'spread': '2.67', 'groupId': 'OG002'}, {'value': '6.06', 'spread': '3.03', 'groupId': 'OG003'}, {'value': '9.21', 'spread': '5.57', 'groupId': 'OG005'}, {'value': '6.44', 'spread': '2.35', 'groupId': 'OG006'}]}]}, {'title': '6 years to <12 years (n=0, 0, 5, 6, 0, 4, 8)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '9.17', 'spread': '4.00', 'groupId': 'OG002'}, {'value': '6.89', 'spread': '1.35', 'groupId': 'OG003'}, {'value': '10.8', 'spread': '4.27', 'groupId': 'OG005'}, {'value': '8.76', 'spread': '3.34', 'groupId': 'OG006'}]}]}, {'title': '12 years to 17 years (n=6 11, 0, 0, 0, 0, 0)', 'categories': [{'measurements': [{'value': '11.0', 'spread': '4.42', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '19.8', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 72 hours post fosaprepitant/aprepitant dose', 'description': 't1/2 is the amount of time from dosing until half of the aprepitant was metabolized from the body. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.'}, {'type': 'PRIMARY', 'title': 'Cmax for Fosaprepitant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part IA-fosaprepitant 115 mg/Aprepitant', 'description': 'Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG001', 'title': 'Part IB-fosaprepitant 150 mg', 'description': 'Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG002', 'title': 'Part IIA-aprepitant 80 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \\<12 years of age - 47 mg/m\\^2; 4 months to \\<6 months of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG003', 'title': 'Part IIB-aprepitant 125 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \\<12 years of age - 74 mg/m\\^2; 6 months to \\<2 years of age - 1.3 mg/kg; 4 months to \\<6 months of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; birth to \\<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG004', 'title': 'Part III-ondansetron', 'description': 'Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \\<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG005', 'title': 'Part IV-aprepitant Regimen', 'description': 'Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG006', 'title': 'Part V-fosaprepitant Regimen', 'description': 'Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}], 'classes': [{'title': '6 months to <2 years (n=0, 0, 0, 0, 0, 0, 7)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '2756', 'spread': '3364', 'groupId': 'OG006'}]}]}, {'title': '2 years to <6 years (n=0, 0, 0, 0, 0, 0, 8)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '3034', 'spread': '1718', 'groupId': 'OG006'}]}]}, {'title': '6 years to <12 years (n=0, 0, 0, 0, 0, 0, 8)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '1654', 'spread': '1995', 'groupId': 'OG006'}]}]}, {'title': '12 years to 17 years (n=0, 11, 0, 0, 0, 0, 0)', 'categories': [{'measurements': [{'value': '1310', 'spread': '964', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 72 hours post fosaprepitant dose', 'description': 'Cmax is a measure of the maximum amount of fosaprepitant in the plasma. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all participants who received at least one dose of fosaprepitant \\& were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III \\& Part IV groups received no fosaprepitant.'}, {'type': 'PRIMARY', 'title': 'Tmax for Fosaprepitant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part IA-fosaprepitant 115 mg/Aprepitant', 'description': 'Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG001', 'title': 'Part IB-fosaprepitant 150 mg', 'description': 'Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG002', 'title': 'Part IIA-aprepitant 80 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \\<12 years of age - 47 mg/m\\^2; 4 months to \\<6 months of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG003', 'title': 'Part IIB-aprepitant 125 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \\<12 years of age - 74 mg/m\\^2; 6 months to \\<2 years of age - 1.3 mg/kg; 4 months to \\<6 months of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; birth to \\<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG004', 'title': 'Part III-ondansetron', 'description': 'Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \\<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG005', 'title': 'Part IV-aprepitant Regimen', 'description': 'Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG006', 'title': 'Part V-fosaprepitant Regimen', 'description': 'Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}], 'classes': [{'title': '6 months to <2 years (n=0, 0, 0, 0, 0, 0, 7)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '1.13', 'spread': '0.175', 'groupId': 'OG006'}]}]}, {'title': '2 years to <6 years (n=0, 0, 0, 0, 0, 0, 7)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '0.089', 'groupId': 'OG006'}]}]}, {'title': '6 years to <12 years (n=0, 0, 0, 0, 0, 0, 8)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG001'}, {'value': '1.04', 'spread': '0.088', 'groupId': 'OG006'}]}]}, {'title': '12 years to 17 years (n=0, 11, 0, 0, 0, 0, 0)', 'categories': [{'measurements': [{'value': '0.614', 'spread': '0.251', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not assessed', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 72 hours post fosaprepitant dose', 'description': 'Tmax is a measure of the amount of time after dosing to when the maximum concentration of fosaprepitant was achieved. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The population consisted of all participants who received at least one dose of fosaprepitant \\& were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III \\& Part IV groups received no fosaprepitant.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part IA-fosaprepitant 115 mg/Aprepitant', 'description': 'Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG001', 'title': 'Part IB-fosaprepitant 150 mg', 'description': 'Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG002', 'title': 'Part IIA-aprepitant 80 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \\<12 years of age - 47 mg/m\\^2; 4 months to \\<6 months of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG003', 'title': 'Part IIB-aprepitant 125 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \\<12 years of age - 74 mg/m\\^2; 6 months to \\<2 years of age - 1.3 mg/kg; 4 months to \\<6 months of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; birth to \\<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG004', 'title': 'Part III-ondansetron', 'description': 'Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \\<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG005', 'title': 'Part IV-aprepitant Regimen', 'description': 'Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG006', 'title': 'Part V-fosaprepitant Regimen', 'description': 'Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after last dose of study drug (Up to 17 days)', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for the occurrence AEs for up to 14 days after last dose of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration and PK Parameters of Dexamethasone in Participants From Birth to 1 Year of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part IA-fosaprepitant 115 mg/Aprepitant', 'description': 'Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG001', 'title': 'Part IB-fosaprepitant 150 mg', 'description': 'Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG002', 'title': 'Part IIA-aprepitant 80 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \\<12 years of age - 47 mg/m\\^2; 4 months to \\<6 months of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG003', 'title': 'Part IIB-aprepitant 125 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \\<12 years of age - 74 mg/m\\^2; 6 months to \\<2 years of age - 1.3 mg/kg; 4 months to \\<6 months of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; birth to \\<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG004', 'title': 'Part III-ondansetron', 'description': 'Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \\<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG005', 'title': 'Part IV-aprepitant Regimen', 'description': 'Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG006', 'title': 'Part V-fosaprepitant Regimen', 'description': 'Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}], 'timeFrame': 'Up to 24 hours post dexamethasone dose', 'description': 'Blood samples for PK assessment were to be collected at the following time points: Parts II and V - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts III and IV - Immediately after infusion of dexamethsone and 0.5, 1.5, 3, 8 and 24 hr post start of chemotherapy.', 'reportingStatus': 'POSTED', 'populationDescription': 'This population was to consist of all participants from birth to 1 year of age who received at least one dose of dexamethasone and were evaluable for this PK parameter. These analyses were not conducted; enrollment of this cohort was not opened as enrollment of participants from birth to \\<6 months of age into Part II was unsuccessful.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Discontinuing Study Drug Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part IA-fosaprepitant 115 mg/Aprepitant', 'description': 'Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG001', 'title': 'Part IB-fosaprepitant 150 mg', 'description': 'Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG002', 'title': 'Part IIA-aprepitant 80 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \\<12 years of age - 47 mg/m\\^2; 4 months to \\<6 months of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG003', 'title': 'Part IIB-aprepitant 125 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \\<12 years of age - 74 mg/m\\^2; 6 months to \\<2 years of age - 1.3 mg/kg; 4 months to \\<6 months of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; birth to \\<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'OG004', 'title': 'Part III-ondansetron', 'description': 'Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \\<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG005', 'title': 'Part IV-aprepitant Regimen', 'description': 'Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.'}, {'id': 'OG006', 'title': 'Part V-fosaprepitant Regimen', 'description': 'Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 3', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. The number of participants who discontinued from the study due to an AE are summarized.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ASaT population consisted of all randomized participants who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part IA-fosaprepitant 115 mg/Aprepitant', 'description': 'Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'FG001', 'title': 'Part IB-fosaprepitant 150 mg', 'description': 'Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'FG002', 'title': 'Part IIA-aprepitant 80 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \\<12 years of age - 47 mg/m\\^2; 4 months to \\<6 months of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'FG003', 'title': 'Part IIB-aprepitant 125 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \\<12 years of age - 74 mg/m\\^2; 6 months to \\<2 years of age - 1.3 mg/kg; 4 months to \\<6 months of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; birth to \\<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'FG004', 'title': 'Part III-ondansetron', 'description': 'Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \\<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.'}, {'id': 'FG005', 'title': 'Part IV-aprepitant Regimen', 'description': 'Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.'}, {'id': 'FG006', 'title': 'Part IV-Additional Enrollers', 'description': 'Additional participants were enrolled in Part IV. Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.'}, {'id': 'FG007', 'title': 'Part V-fosaprepitant Regimen', 'description': 'Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'FG008', 'title': 'Part V-Additional Enrollers', 'description': 'Additional participants were enrolled in Part V. Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}], 'periods': [{'title': 'Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Part I', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Newly enrolled participants', 'groupId': 'FG000', 'numSubjects': '12'}, {'comment': 'Newly enrolled participants', 'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Part II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Newly enrolled participants', 'groupId': 'FG002', 'numSubjects': '19'}, {'comment': 'Newly enrolled participants', 'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', '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'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Not Treated', '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'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Part III', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Newly enrolled participants', 'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Part IV', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Participants continuing from Part III', 'groupId': 'FG005', 'numSubjects': '15'}, {'comment': 'Newly enrolled participants', 'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Part V', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'comment': 'Participants continuing from Part IV', 'groupId': 'FG007', 'numSubjects': '17'}, {'comment': 'Newly enrolled participants', 'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '16'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of the 92 unique participants who were enrolled and randomized in Parts I (n=23), II (n=39), III (n=19), IV (n=5) and V (n=6), 91 took part in this study. One participant randomized in Part IIB was discontinued prior to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '92', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Part IA-fosaprepitant 115 mg/Aprepitant', 'description': 'Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'BG001', 'title': 'Part IB-fosaprepitant 150 mg', 'description': 'Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'BG002', 'title': 'Part IIA-aprepitant 80 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \\<12 years of age - 47 mg/m\\^2; 4 months to \\<6 months of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'BG003', 'title': 'Part IIB-aprepitant 125 mg Equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \\<12 years of age - 74 mg/m\\^2; 6 months to \\<2 years of age - 1.3 mg/kg; 4 months to \\<6 months of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; birth to \\<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'BG004', 'title': 'Part III-ondansetron', 'description': 'Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \\<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.'}, {'id': 'BG005', 'title': 'Part IV-aprepitant Regimen', 'description': 'Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.'}, {'id': 'BG006', 'title': 'Part V-fosaprepitant Regimen', 'description': 'Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '6 months to <2 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}]}]}, {'title': '2 years to <6 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}]}]}, {'title': '6 years to <12 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '25', 'groupId': 'BG007'}]}]}, {'title': '12 years to 17 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '62', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '30', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'For analysis purposes, baseline (BL) data are presented by study part groups. The BL analysis population includes all unique enrolled participants in Parts I, II, III, IV and V. Part III participants who entered Parts IV and V are only counted in Part III; Part IV participants who entered Part V are only counted in Part IV.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'whyStopped': 'Study terminated early prior to completing targeted enrollment of participants \\<6 months of age due to recruitment challenges.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2014-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2009-01-06', 'resultsFirstSubmitDate': '2014-10-02', 'studyFirstSubmitQcDate': '2009-01-06', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-14', 'studyFirstPostDateStruct': {'date': '2009-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant', 'timeFrame': 'Up to 24 hours post fosaprepitant/aprepitant dose', 'description': 'AUC is a measure of the amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for pharmacokinetic (PK) assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hours (hr) post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy.'}, {'measure': 'Maximum Plasma Concentration (Cmax) for Aprepitant', 'timeFrame': 'Up to 72 hours post fosaprepitant/aprepitant dose', 'description': 'Cmax is a measure of the maximum amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.'}, {'measure': 'Time to Cmax (Tmax) for Aprepitant', 'timeFrame': 'Up to 72 hours post fosaprepitant/aprepitant dose', 'description': 'Tmax is a measure of the amount of time after dosing to when the maximum concentration of aprepitant was achieved. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.'}, {'measure': 'Apparent Terminal Half-life (t1/2) for Aprepitant', 'timeFrame': 'Up to 72 hours post fosaprepitant/aprepitant dose', 'description': 't1/2 is the amount of time from dosing until half of the aprepitant was metabolized from the body. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.'}, {'measure': 'Cmax for Fosaprepitant', 'timeFrame': 'Up to 72 hours post fosaprepitant dose', 'description': 'Cmax is a measure of the maximum amount of fosaprepitant in the plasma. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.'}, {'measure': 'Tmax for Fosaprepitant', 'timeFrame': 'Up to 72 hours post fosaprepitant dose', 'description': 'Tmax is a measure of the amount of time after dosing to when the maximum concentration of fosaprepitant was achieved. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.'}, {'measure': 'Number of Participants Experiencing Adverse Events (AEs)', 'timeFrame': 'Up to 14 days after last dose of study drug (Up to 17 days)', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for the occurrence AEs for up to 14 days after last dose of study drug.'}, {'measure': 'Number of Participants Discontinuing Study Drug Due to an AE', 'timeFrame': 'Day 1 up to Day 3', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. The number of participants who discontinued from the study due to an AE are summarized.'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentration and PK Parameters of Dexamethasone in Participants From Birth to 1 Year of Age', 'timeFrame': 'Up to 24 hours post dexamethasone dose', 'description': 'Blood samples for PK assessment were to be collected at the following time points: Parts II and V - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts III and IV - Immediately after infusion of dexamethsone and 0.5, 1.5, 3, 8 and 24 hr post start of chemotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chemotherapy-Induced Nausea and Vomiting']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=0869-134&kw=0869-134&tab=access', 'type': 'CSR Snyopsis'}], 'references': [{'pmid': '25770814', 'type': 'RESULT', 'citation': 'Kang HJ, Loftus S, Taylor A, DiCristina C, Green S, Zwaan CM. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in children: a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):385-94. doi: 10.1016/S1470-2045(15)70061-6. Epub 2015 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0 months to 17 years of age.', 'detailedDescription': 'Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after intravenous administration; the pharmacological effect of fosaprepitant is attributed to aprepitant. The birth to one year old cohort will be initiated in Parts III and IV upon completion of Part II (Steps A and B) in participants \\<6 months of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is 0 (at least 37 weeks gestation) to 17 years of age\n* Is scheduled to receive moderately to highly nausea-inducing chemotherapy or participant did not tolerate a previous chemotherapy regimen that is planned to be repeated\n* Is expected to receive ondansetron\n* Female participants who have begun menstruating must have a negative pregnancy test\n* Weighs ≥3.0 kg if \\<6 months of age, ≥6.0 kg if \\>6 months of age, and ≥7.5 kg if \\> 2 years of age\n* Has a pre-existing venous catheter\n\nExclusion Criteria:\n\n* Uses any illicit drugs or abuses alcohol\n* Is pregnant or breast feeding\n* Has a symptomatic central nervous system (CNS) tumor\n* Has an infection or other uncontrolled disease other than cancer\n* Has known history of heart QT wave prolongation'}, 'identificationModule': {'nctId': 'NCT00818259', 'briefTitle': 'A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Open-Label, 5-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Pediatric Patients Receiving Emetogenic Chemotherapy', 'orgStudyIdInfo': {'id': '0869-134'}, 'secondaryIdInfos': [{'id': '2009_501', 'type': 'OTHER', 'domain': 'Telerx Study Identifier'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part IA-fosaprepitant 115 mg/aprepitant', 'description': 'Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.', 'interventionNames': ['Drug: Experimental: aprepitant', 'Drug: Experimental: fosaprepitant', 'Drug: Ondansetron', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Part IB-fosaprepitant 150 mg', 'description': 'Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.', 'interventionNames': ['Drug: Experimental: fosaprepitant', 'Drug: Ondansetron', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Part IIA-aprepitant 80 mg equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to \\<12 years of age - 47 mg/m\\^2; 4 months to \\<6 months of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.', 'interventionNames': ['Drug: Experimental: aprepitant', 'Drug: Ondansetron', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Part IIB-aprepitant 125 mg equiv.', 'description': 'Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to \\<12 years of age - 74 mg/m\\^2; 6 months to \\<2 years of age - 1.3 mg/kg; 4 months to \\<6 months of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; birth to \\<1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.', 'interventionNames': ['Drug: Experimental: aprepitant', 'Drug: Ondansetron', 'Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part III-ondansetron', 'description': 'Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to \\<12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.', 'interventionNames': ['Drug: Comparator: ondansetron', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Part IV-aprepitant regimen', 'description': 'Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 3.0 mg/kg; 1 month to \\<4 months of age - 1.5 mg/kg; Birth to \\<1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to \\<12 years of age - 2.0 mg/kg; 1 month to \\<4 months of age - 1.0 mg/kg; Birth to \\<1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.', 'interventionNames': ['Drug: Experimental: aprepitant', 'Drug: Ondansetron', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Part V-fosaprepitant regimen', 'description': 'Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to \\<12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.', 'interventionNames': ['Drug: Experimental: fosaprepitant', 'Drug: Ondansetron', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Experimental: aprepitant', 'type': 'DRUG', 'otherNames': ['Emend', 'MK-0869'], 'description': 'aprepitant powder for suspension, 125 mg/sachet, PO', 'armGroupLabels': ['Part IA-fosaprepitant 115 mg/aprepitant', 'Part IIA-aprepitant 80 mg equiv.', 'Part IIB-aprepitant 125 mg equiv.', 'Part IV-aprepitant regimen']}, {'name': 'Experimental: fosaprepitant', 'type': 'DRUG', 'otherNames': ['Emend injection', 'Fosaprepitant Dimeglumine', 'MK-0517'], 'description': 'fosaprepitant lyophilized powder for suspension, 115 mg/vial or 150 mg/vial, IV', 'armGroupLabels': ['Part IA-fosaprepitant 115 mg/aprepitant', 'Part IB-fosaprepitant 150 mg', 'Part V-fosaprepitant regimen']}, {'name': 'Comparator: ondansetron', 'type': 'DRUG', 'otherNames': ['Zofran'], 'description': 'ondansetron solution for infusion, IV, administered per local standard of care', 'armGroupLabels': ['Part III-ondansetron']}, {'name': 'Ondansetron', 'type': 'DRUG', 'description': 'ondansetron solution for infusion, IV, administered per local standard of care', 'armGroupLabels': ['Part IA-fosaprepitant 115 mg/aprepitant', 'Part IB-fosaprepitant 150 mg', 'Part IIA-aprepitant 80 mg equiv.', 'Part IIB-aprepitant 125 mg equiv.', 'Part IV-aprepitant regimen', 'Part V-fosaprepitant regimen']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'dexamethasone solution for infusion, IV, administered per local standard of care', 'armGroupLabels': ['Part IA-fosaprepitant 115 mg/aprepitant', 'Part IB-fosaprepitant 150 mg', 'Part IIA-aprepitant 80 mg equiv.', 'Part IIB-aprepitant 125 mg equiv.', 'Part III-ondansetron', 'Part IV-aprepitant regimen', 'Part V-fosaprepitant regimen']}]}, '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'}}}}