Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-05 @ 11:03 PM
Study NCT ID:
NCT01732458
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2012-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Canada', 'Chile', 'Czechia', 'Guatemala', 'Hungary', 'Italy', 'Mexico', 'Peru', 'Puerto Rico', 'Russia', 'South Africa', 'Spain', 'Turkey (Türkiye)', 'Ukraine', 'United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077608', 'term': 'Aprepitant'}, {'id': 'D017294', 'term': 'Ondansetron'}], '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'}]}}, '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. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From pre-operative phase up to Follow-up (up to 17 days)', 'description': 'All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Aprepitant 125 mg Adult Equivalent (Dose 1)', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.', 'otherNumAtRisk': 57, 'otherNumAffected': 11, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aprepitant 40 mg Adult Equivalent (Dose 2)', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.', 'otherNumAtRisk': 55, 'otherNumAffected': 11, 'seriousNumAtRisk': 55, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Aprepitant 10 mg Adult Equivalent (Dose 3)', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.', 'otherNumAtRisk': 56, 'otherNumAffected': 12, 'seriousNumAtRisk': 56, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Ondansetron', 'description': 'Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.', 'otherNumAtRisk': 52, 'otherNumAffected': 16, 'seriousNumAtRisk': 52, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bladder perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Male genital tract fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of Aprepitant From Time 0 to the Last Measurable Concentration (AUC0-last) Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '7120', 'spread': '33.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using a noncompartmental analysis (NCA). The limit of quantitation (LOQ) value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Maximum Concentration (Cmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '1340', 'spread': '43.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time to Maximum Concentration (Tmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.86', 'spread': '56.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hour (hr)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to <12', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to \\<12 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '10300', 'spread': '39.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 6 to \\<12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to <12', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to \\<12 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '1870', 'spread': '53.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 6 to \\<12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to <12', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to \\<12 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.82', 'spread': '26.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 6 to \\<12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to <6', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to \\<6 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '12000', 'spread': '39.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 2 to \\<6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to <6', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to \\<6 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '2260', 'spread': '35.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 2 to \\<6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to <6', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to \\<6 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.91', 'spread': '51.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 2 to \\<6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to <2', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to \\<2 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '6410', 'spread': '67.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged birth to \\<2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. Two participants were excluded from the analysis, due to a missing 8-hour post-dose sample and aprepitant concentration in the pre-dose sample, respectively.'}, {'type': 'PRIMARY', 'title': 'Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to <2', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to \\<2 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '1280', 'spread': '78.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged birth to \\<2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due to aprepitant concentration in the pre-dose sample.'}, {'type': 'PRIMARY', 'title': 'Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to <2', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to \\<2 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.71', 'spread': '51.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged birth to \\<2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-last Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '2570', 'spread': '41.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Cmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '513', 'spread': '41.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Tmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.17', 'spread': '69.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to <12', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to \\<12 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '4730', 'spread': '60.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 6 to \\<12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to <12', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to \\<12 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '930', 'spread': '66.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 6 to \\<12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to <12', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to \\<12 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.22', 'spread': '53.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 6 to \\<12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to <6', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to \\<6 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '6320', 'spread': '78.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 2 to \\<6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to <6', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to \\<6 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '1290', 'spread': '81.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 2 to \\<6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to <6', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to \\<6 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.35', 'spread': '43.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 2 to \\<6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to <2', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to \\<2 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '7910', 'spread': '153.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged birth to \\<2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.'}, {'type': 'PRIMARY', 'title': 'Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to <2', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to \\<2 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '1570', 'spread': '146.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged birth to \\<2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.'}, {'type': 'PRIMARY', 'title': 'Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to <2', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to \\<2 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.94', 'spread': '38.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged birth to \\<2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-last Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '806', 'spread': '51.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '131', 'spread': '50.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.53', 'spread': '54.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to <12', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to \\<12 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '1390', 'spread': '77.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 6 to \\<12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to <12', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to \\<12 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '289', 'spread': '128.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 6 to \\<12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to <12', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to \\<12 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.75', 'spread': '57.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 6 to \\<12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to <6', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to \\<6 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '1580', 'spread': '45.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 2 to \\<6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to <6', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to \\<6 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '300', 'spread': '49.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 2 to \\<6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to <6', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to \\<6 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.36', 'spread': '45.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged 2 to \\<6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to <2', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to \\<2 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '1800', 'spread': '107.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged birth to \\<2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to <2', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to \\<2 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '336', 'spread': '112.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged birth to \\<2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to <2', 'description': 'Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to \\<2 years old.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.11', 'spread': '48.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.', 'unitOfMeasure': 'hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants aged birth to \\<2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC0-inf) Following Administration of Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG001', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG002', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG003', 'title': 'Ondansetron', 'description': 'Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia'}], 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Plasma for aprepitant AUC0-inf assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. AUC0-inf data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. AUC0-inf) was not possible.'}, {'type': 'PRIMARY', 'title': 'Apparent Total Clearance (CL/F) of Aprepitant From Plasma Following Administration of Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG001', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG002', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG003', 'title': 'Ondansetron', 'description': 'Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia'}], 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Plasma for aprepitant CL/F assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. CL/F data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. CL/F) was not possible.'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Half-life (t ½) of Aprepitant Following Administration of Single Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG001', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG002', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG003', 'title': 'Ondansetron', 'description': 'Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia'}], 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Plasma for aprepitant t ½ assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. t ½ data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. t ½) was not possible.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG001', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG002', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG003', 'title': 'Ondansetron', 'description': 'Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000'}, {'value': '43.6', 'groupId': 'OG001'}, {'value': '35.7', 'groupId': 'OG002'}, {'value': '48.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percentage vs. Ondansetron', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.5', 'ciLowerLimit': '-34.0', 'ciUpperLimit': '2.0', 'groupDescription': 'The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in Percentage vs. Ondansetron', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-22.9', 'ciUpperLimit': '14.3', 'groupDescription': 'The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Percentage vs. Ondansetron', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.4', 'ciLowerLimit': '-30.3', 'ciUpperLimit': '6.3', 'groupDescription': 'The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From pre-operative phase up to Follow-up (Day 1 to Day 15)', 'description': "An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants experiencing ≥1 AE was reported by dose group.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment were analyzed.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Discontinuing Study Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG001', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG002', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'OG003', 'title': 'Ondansetron', 'description': 'Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From pre-operative phase up to Follow-up (Day 1 to Day 15)', 'description': "An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants discontinuing study due to an AE was reported by dose group.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.'}, {'id': 'FG001', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'FG002', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'FG003', 'title': 'Ondansetron', 'description': 'Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '56'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '53'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-Compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of 262 screened for inclusion, 229 were randomized to treatment. 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose arm that was not evaluated in this study; therefore the participant was not included in any analyses. Of remaining 228 randomized participants, 8 did not receive treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '220', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.'}, {'id': 'BG001', 'title': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'BG002', 'title': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults', 'description': 'Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.'}, {'id': 'BG003', 'title': 'Ondansetron', 'description': 'Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '90.4', 'spread': '64.3', 'groupId': 'BG000'}, {'value': '87.5', 'spread': '64.6', 'groupId': 'BG001'}, {'value': '85.1', 'spread': '59.7', 'groupId': 'BG002'}, {'value': '86.0', 'spread': '65.0', 'groupId': 'BG003'}, {'value': '87.3', 'spread': '63.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Birth to <2 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}]}, {'title': '2 years to <6 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}]}, {'title': '6 years to <12 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}]}, {'title': '12 years to 17 years', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '134', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Participants as Treated (APaT) population; all randomized participants who received at least 1 dose of study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'This study will be conducted as a partially blinded study. PK samples will not be collected from participants in the control group. To maintain a partial blind, approximately 3 participants randomly selected from each age group in each of the aprepitant treatment groups will not have PK sampling. All participants will remain blinded to the study treatment. The investigator and Sponsor will be blinded to the study medication in participants not providing PK samples. The investigator and Sponsor will remain blinded to the aprepitant dose given to participants from whom PK samples will be collected.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2012-11-19', 'resultsFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2012-11-19', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-04', 'studyFirstPostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of Aprepitant From Time 0 to the Last Measurable Concentration (AUC0-last) Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using a noncompartmental analysis (NCA). The limit of quantitation (LOQ) value for this analysis was 10 ng/mL.'}, {'measure': 'Maximum Concentration (Cmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Time to Maximum Concentration (Tmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'AUC0-last Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Cmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Tmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'AUC0-last Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to \\<12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to \\<6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to \\<2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.'}, {'measure': 'Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC0-inf) Following Administration of Single Dose', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Plasma for aprepitant AUC0-inf assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. AUC0-inf data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.'}, {'measure': 'Apparent Total Clearance (CL/F) of Aprepitant From Plasma Following Administration of Single Dose', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Plasma for aprepitant CL/F assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. CL/F data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.'}, {'measure': 'Apparent Terminal Half-life (t ½) of Aprepitant Following Administration of Single Dose', 'timeFrame': '30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration', 'description': 'Plasma for aprepitant t ½ assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. t ½ data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.'}, {'measure': 'Percentage of Participants Experiencing at Least One Adverse Event (AE)', 'timeFrame': 'From pre-operative phase up to Follow-up (Day 1 to Day 15)', 'description': "An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants experiencing ≥1 AE was reported by dose group."}, {'measure': 'Percentage of Participants Discontinuing Study Due to an AE', 'timeFrame': 'From pre-operative phase up to Follow-up (Day 1 to Day 15)', 'description': "An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants discontinuing study due to an AE was reported by dose group."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-operative Nausea', 'Post-operative Vomiting']}, 'referencesModule': {'references': [{'pmid': '30381138', 'type': 'DERIVED', 'citation': 'Salman FT, DiCristina C, Chain A, Afzal AS. Pharmacokinetics and pharmacodynamics of aprepitant for the prevention of postoperative nausea and vomiting in pediatric subjects. J Pediatr Surg. 2019 Jul;54(7):1384-1390. doi: 10.1016/j.jpedsurg.2018.09.006. Epub 2018 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of aprepitant for the prevention of post-operative nausea and vomiting (PONV) in pediatric participants.\n\nPost-operative aprepitant plasma concentrations will be evaluated with a non-compartmental analysis (NCA) at each dose and for each age cohort. Full PK profiles analyzed using population PK modeling and simulation will be described in a separate report.', 'detailedDescription': 'Because the opportunity to collect specimens for PK analyses in children will be limited, a flexible sparse sampling scheme using ranges of collection times will be utilized which will limit the burden to participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant enrolled at birth should be at least 37 weeks gestation and ≥3 kg of weight\n* Scheduled to receive general anesthesia AND must have at least one of the following risk factors for post-operative nausea and vomiting (PONV) in addition to receiving general anesthesia:\n\n 1. scheduled to have a surgery with an associated risk of PONV: tonsillectomy, adenoidectomy, strabismus surgery, dental surgery, hydrocelectomy, orchidopexy or herniorraphy; OR\n 2. scheduled to have an operative procedure associated with PONV: intraoperative opioid use or anticipated opioid administration within the first 24 hours following surgery.\n\nExclusion Criteria:\n\n* Emergency surgery for a life-threatening condition\n* Scheduled to receive propofol for maintenance of anesthesia (Note: propofol is permitted for induction of anesthesia).\n* Expected to receive opioid antagonists (e.g., naloxone, naltrexone) or\n\nbenzodiazepine antagonists (e.g., flumazenil)\n\n* Scheduled to undergo cardiac or neurosurgery\n* Vomiting caused by any organic etiology (such as gastric outlet\n\nobstruction or small bowel obstruction)\n\n* Vomiting within 24 hours prior to surgery\n* Participant had a nasogastric or oral gastric tube intra- or post-operatively for suctioning gastric contents (note: nasogastric or oral gastric tube intra- or post-operatively could only be used for feeding. Participants were to be excluded if a nasogastric or oral gastric tube for suctioning was routinely used for the type of surgery being performed)\n* Active infection (e.g., pneumonia), congestive heart failure, bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, or a history of any illness which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk to the participant\n* Use of any illicit drugs, including marijuana or has current evidence of alcohol abuse'}, 'identificationModule': {'nctId': 'NCT01732458', 'briefTitle': 'A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Aprepitant in Pediatric Patients for the Prevention of Post Operative Nausea and Vomiting', 'orgStudyIdInfo': {'id': '0869-219'}, 'secondaryIdInfos': [{'id': '2011-006006-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aprepitant Dose 1: Equivalent to 125 mg in Adults', 'description': 'Pediatric participants receive a single dose of apprepitant that is equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.', 'interventionNames': ['Drug: Aprepitant', 'Drug: Placebo to match ondansetron']}, {'type': 'EXPERIMENTAL', 'label': 'Aprepitant Dose 2: Equivalent to 40 mg in Adults', 'description': 'Pediatric participants receive a single dose of apprepitant that is equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.', 'interventionNames': ['Drug: Aprepitant', 'Drug: Placebo to match ondansetron']}, {'type': 'EXPERIMENTAL', 'label': 'Aprepitant Dose 3: Equivalent to 10 mg in Adults', 'description': 'Pediatric participants receive a single dose of apprepitant that is equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.', 'interventionNames': ['Drug: Aprepitant', 'Drug: Placebo to match ondansetron']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ondansetron', 'description': 'Pediatric participants in the control regimen are administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.', 'interventionNames': ['Drug: Placebo to Aprepitant', 'Drug: Ondansetron']}], 'interventions': [{'name': 'Aprepitant', 'type': 'DRUG', 'otherNames': ['MK-0869', 'EMEND™'], 'description': 'Administered as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia. Aprepitant was supplied in a sachet containing a powder for suspension (PFS) that was reconstituted up to total volume of 5 mL using potable water.', 'armGroupLabels': ['Aprepitant Dose 1: Equivalent to 125 mg in Adults', 'Aprepitant Dose 2: Equivalent to 40 mg in Adults', 'Aprepitant Dose 3: Equivalent to 10 mg in Adults']}, {'name': 'Placebo to Aprepitant', 'type': 'DRUG', 'otherNames': ['Matching placebo to aprepritant was administered as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.'], 'armGroupLabels': ['Ondansetron']}, {'name': 'Ondansetron', 'type': 'DRUG', 'otherNames': ['Zofran'], 'description': 'Administered IV at a dose of 4 mg for participants \\>40 kg in weight and 0.1 mg/kg for participants ≤40 kg in weight. In participants \\<1 month of age, the dose of ondansetron was administered per the product label or based on local standard of care. Ondansetron was supplied by the Sponsor as vials or ampules, depending on the country.', 'armGroupLabels': ['Ondansetron']}, {'name': 'Placebo to match ondansetron', 'type': 'DRUG', 'description': 'Participants in the aprepitant regimen received normal saline IV (provided by the site) as the placebo for ondansetron on Day 1, immediately prior to induction of anesthesia.', 'armGroupLabels': ['Aprepitant Dose 1: Equivalent to 125 mg in Adults', 'Aprepitant Dose 2: Equivalent to 40 mg in Adults', 'Aprepitant Dose 3: Equivalent to 10 mg in Adults']}]}, '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'}}}}