Study of the Pharmacokinetics, Pharmacodynamics, Safety a... | NCT01697579 | Trialant
NCT01697579
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Jun 25, 2019Actual
Enrollment
240Actual
Phase
Phase 2
Conditions
Chemotherapy-induced Nausea and Vomiting
Interventions
Fosaprepitant
Fosaprepitant Placebo
Ondansetron
5-hydroxytryptamine 3 antagonist
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01697579
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
0517-029
Secondary IDs
ID
Type
Description
Link
2012-002340-24
EudraCT Number
MK-0517-029
Other Identifier
Merck Protocol Number
Brief Title
Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)
Official Title
A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Emetogenic Chemotherapy Sub-title: Open-Label Cohort to Further Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients Birth to <12 Years Old
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jun 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 13, 2012Actual
Primary Completion Date
Nov 21, 2016Actual
Completion Date
Nov 21, 2016Actual
First Submitted Date
Sep 28, 2012
First Submission Date that Met QC Criteria
Sep 28, 2012
First Posted Date
Oct 2, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 18, 2017
Results First Submitted that Met QC Criteria
Oct 18, 2017
Results First Posted Date
Nov 21, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 14, 2019
Last Update Posted Date
Jun 25, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study was to determine the appropriate dosing regimen of fosaprepitant, when administered with ondansetron (with or without dexamethasone), for the prevention of CINV in children from birth to <17 years of age. Fosaprepitant is a prodrug to aprepitant. All participants who completed the randomized Cycle 1 could elect to receive open-label fosaprepitant during optional Cycles 2-6.
Detailed Description
Under Amendment 01, 0517-029 enrolled participants in the following age cohorts: 2-<6, 6-<12 and 12-17 years old. The study was randomized, partially-blinded, with parallel group assignment. Participants were randomized to one of three fosaprepitant doses or the control group. (Amendment 02 and Amendment 03 were country-specific amendments in Brazil that were required as per local regulations with no change in study design.) Under Amendment 04, the 12-17 year-old cohort was closed since that cohort fully enrolled. An additional fosaprepitant dose was added and all participants were allocated to this one treatment group. Amendment 04 was open-label and enrolled participants in the following age cohorts: 0-<2, 2-<6 and 6-<12 years old.
Conditions Module
Conditions
Chemotherapy-induced Nausea and Vomiting
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
240Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Fosaprepitant 5 mg/kg-Cycle 1
Experimental
Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Drug: Fosaprepitant
Drug: Ondansetron
Fosaprepitant 3 mg/kg-Cycle 1
Experimental
Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Drug: Fosaprepitant
Drug: Ondansetron
Fosaprepitant 1.2 mg/kg-Cycle 1
Experimental
Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Drug: Fosaprepitant
Drug: Ondansetron
Fosaprepitant 0.4 mg/kg-Cycle 1
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Fosaprepitant
Drug
Administered intravenously (IV) as a single dose
Fosaprepitant 0.4 mg/kg-Cycle 1
Fosaprepitant 1.2 mg/kg-Cycle 1
Fosaprepitant 3 mg/kg-Cycle 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Maximum Concentration (Cmax) of Aprepitant in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
Time to Maximum Concentration (Tmax) of Aprepitant in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC 0-∞) in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
Area Under the Concentration-time Curve of Aprepitant From Time 0 to 24 Hours (AUC 0-24hr) in Participants 0 to <2 Years of Age
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Is 0 months (at least 37 weeks gestation) to <18 years of age
Scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very high risk of emetogenicity for no more than 5 consecutive days for a documented malignancy, or a chemotherapy regimen not previously tolerated due to vomiting
Expected to receive ondansetron as part of antiemetic regimen (Cycle 1); Expected to receive a 5-HT3 antagonist as part of antiemetic regimen (Cycles 2-6)
If female and has begun menstruating, must have a negative pregnancy test prior to study participation and agree to remain abstinent or use a barrier form of contraception
Predicted life expectancy of ≥3 months
Pre-existing functioning central venous catheter
Weight ≥3rd percentile for age and gender (and ≥3.0 kg)
Exclusion Criteria:
Vomited in the 24 hours prior study drug administration (Cycle 1)
Current user of any illicit drugs (including marijuana) or current evidence of alcohol abuse
Scheduled to receive stem cell rescue therapy in conjunction with study related course(s) of emetogenic chemotherapy
Received or will receive radiation therapy to the abdomen or pelvis in the week prior to study drug administration and/or during the course of the study
Pregnant or breast feeding
Allergic to fosaprepitant, aprepitant, ondansetron, or any other 5-HT3 antagonist
Has a symptomatic central nervous system (CNS) tumor causing nausea and/or vomiting
Has an active infection, congestive heart failure, slow heart rate, or other uncontrolled disease other than cancer
Mentally incapacitated or has a significant emotional or psychiatric disorder
Known history of QT prolongation or is taking any medication known to lead to QT prolongation
Taking other excluded medications
Participated in any previous study of aprepitant or fosaprepitant, or taken an investigational drug within 4 weeks prior to study participation
Mora J, Valero M, DiCristina C, Jin M, Chain A, Bickham K. Pharmacokinetics/pharmacodynamics, safety, and tolerability of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients. Pediatr Blood Cancer. 2019 Jun;66(6):e27690. doi: 10.1002/pbc.27690. Epub 2019 Mar 21.
Participants (2 to <6, 6 to <12 and 12 to17 years-old) were enrolled in a randomized, partially-blinded study of 4 doses of fosaprepitant and a control in Cycle 1. Participants (0 to <2, 2 to <6 and 6 to <12 years-old) were invited to participate in optional Cycles 2-6 which was an open-label study of 2 doses of fosaprepitant.
Recruitment Details
This study enrolled participants scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very high risk of emetogenicity for no more than 5 consecutive days and were expected to receive ondansetron as part of their antiemetic regimen. Additional inclusion and exclusion criteria applied.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Fosaprepitant 5 mg/Kg-Cycle 1
Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Periods
Title
Milestones
Reasons Not Completed
Base Study-Cycle 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Austria
Brazil
Canada
Chile
Colombia
Estonia
Germany
Greece
Hungary
Italy
Lithuania
Mexico
Peru
Portugal
Romania
Russia
South Africa
South Korea
Spain
Switzerland
Taiwan
Turkey (Türkiye)
Ukraine
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Experimental
Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Drug: Fosaprepitant
Drug: Ondansetron
Placebo Control-Cycle 1
Placebo Comparator
Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Drug: Fosaprepitant Placebo
Drug: Ondansetron
Fosaprepitant 5 mg/kg-Cycles 2-6
Experimental
For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.
Drug: Fosaprepitant
Drug: 5-hydroxytryptamine 3 antagonist
Fosaprepitant 3 mg/kg-Cycles 2-6
Experimental
For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
Drug: Fosaprepitant
Drug: 5-hydroxytryptamine 3 antagonist
Fosaprepitant 3 mg/kg-Cycles 2-6
Fosaprepitant 5 mg/kg-Cycle 1
Fosaprepitant 5 mg/kg-Cycles 2-6
Fosaprepitant dimeglumine
MK-0517
EMEND® for Injection
Fosaprepitant Placebo
Drug
Administered IV as a single dose
Placebo Control-Cycle 1
Ondansetron
Drug
Administered IV according to local labeling and/or local standard of care
Fosaprepitant 0.4 mg/kg-Cycle 1
Fosaprepitant 1.2 mg/kg-Cycle 1
Fosaprepitant 3 mg/kg-Cycle 1
Fosaprepitant 5 mg/kg-Cycle 1
Placebo Control-Cycle 1
Ondansetron hydrochloride
Zofran® Injection
5-hydroxytryptamine 3 antagonist
Drug
Administered IV according to local labeling and/or local standard of care
Fosaprepitant 3 mg/kg-Cycles 2-6
Fosaprepitant 5 mg/kg-Cycles 2-6
5-HT3
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
Apparent Terminal Half-life (t1/2) of Aprepitant in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
Concentration of Aprepitant After 24 Hours (C24hr) in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.
Approximately 24 hours (from 23 to 25 hours) post-infusion
Concentration of Aprepitant After 48 Hours (C48hr) in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.
Approximately 48 hours (from 46 to 50 hours) post-infusion
Apparent Total Body Clearance (CL/F) of Aprepitant in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
Cmax of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
Tmax of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
AUC 0-∞ of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
AUC 0-24hr of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
t1/2 of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
C24hr of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.
Approximately 24 hours (from 23 to 25 hours) post-infusion
C48hr of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.
Approximately 48 hours (from 46 to 50 hours) post-infusion
CL/F of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
Cmax of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
Tmax of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
AUC 0-∞ of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
AUC 0-24hr of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
t1/2 of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
C24hr of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.
Approximately 24 hours (from 23 to 25 hours) post-infusion
C48hr of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.
Approximately 48 hours (from 46 to 50 hours) post-infusion
CL/F of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
Cmax of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
Tmax of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
AUC 0-∞ of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
AUC 0-24hr of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
t1/2 of Aprepitant in Participants 12 to 17 Years of Age Hours
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
C24hr of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.
Approximately 24 hours (from 23 to 25 hours) post-infusion
C48hr of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.
Approximately 48 hours (from 46 to 50 hours) post-infusion
CL/F of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycle 1
AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.
Up to 14 days postdose in Cycle 1
Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycles 2-6
AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.
Up to 14 days postdose for each cycle (Cycles 2-6)
FG001
Fosaprepitant 3 mg/Kg-Cycle 1
Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
FG002
Fosaprepitant 1.2 mg/Kg-Cycle 1
Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
FG003
Fosaprepitant 0.4 mg/Kg-Cycle 1
Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
FG004
Placebo Control-Cycle 1
Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
FG005
Fosaprepitant 5 mg/Kg-Cycles 2-6
For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.
FG006
Fosaprepitant 3 mg/Kg-Cycles 2-6
For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
FG00074 subjectsParticipants who completed Cycle 1 were invited to participate in optional Cycles 2-6 arms.
FG00143 subjectsParticipants who completed Cycle 1 were invited to participate in optional Cycles 2-6 arms.
FG00244 subjectsParticipants who completed Cycle 1 were invited to participate in optional Cycles 2-6 arms.
FG00341 subjectsParticipants who completed Cycle 1 were invited to participate in optional Cycles 2-6 arms.
FG00438 subjectsParticipants who completed Cycle 1 were invited to participate in optional Cycles 2-6 arms.
FG0050 subjectsEnrollment in Cycles 2-6 was optional.
FG0060 subjectsEnrollment in Cycles 2-6 was optional.
COMPLETED
FG00072 subjects
FG00142 subjects
FG00243 subjects
FG00340 subjects
FG00435 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Withdrawal by Parent/Guardian
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Consent Withdrawn by Participant
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Technical Problems
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Optional Extension-Cycles 2-6
Type
Comment
Milestone Data
STARTED
FG0000 subjects47 participants from this arm in Cycle 1 entered optional Cycles 2-6 at 5 mg/kg
FG0010 subjects33 participants from this arm in Cycle 1 entered optional Cycles 2-6 at 3 mg/kg
FG0020 subjects25 participants from this arm in Cycle 1 entered optional Cycles 2-6 at 3 mg/kg
FG0030 subjects27 participants from this arm in Cycle 1 entered optional Cycles 2-6 at 3 mg/kg
FG0040 subjects21 participants from this arm in Cycle 1 entered optional Cycles 2-6 at 3 mg/kg
FG00547 subjectsEnrollment in Cycles 2-6 was optional.
FG006106 subjectsEnrollment in Cycles 2-6 was optional.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Fosaprepitant 5 mg/Kg-Cycle 1
Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
BG001
Fosaprepitant 3 mg/Kg-Cycle 1
Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
BG002
Fosaprepitant 1.2 mg/Kg-Cycle 1
Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
BG003
Fosaprepitant 0.4 mg/Kg-Cycle 1
Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
BG004
Placebo Control-Cycle 1
Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00074
BG00143
BG00244
BG00341
BG00438
BG005240
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Months
Title
Denominators
Categories
Title
Measurements
BG00060.2± 42.3
BG001123.8± 51.3
BG002119.4± 52.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00032
BG00118
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Maximum Concentration (Cmax) of Aprepitant in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
ng/mL
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1
Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Units
Counts
Participants
OG00022
Title
Denominators
Categories
Title
Measurements
OG0003550± 1500
Primary
Time to Maximum Concentration (Tmax) of Aprepitant in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hours
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1
Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Units
Primary
Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC 0-∞) in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hr•ng/mL
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1
Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Primary
Area Under the Concentration-time Curve of Aprepitant From Time 0 to 24 Hours (AUC 0-24hr) in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hr•ng/mL
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1
Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Primary
Apparent Terminal Half-life (t1/2) of Aprepitant in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hours
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1
Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Units
Primary
Concentration of Aprepitant After 24 Hours (C24hr) in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.
All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
ng/mL
Approximately 24 hours (from 23 to 25 hours) post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1
Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Units
Counts
Participants
Primary
Concentration of Aprepitant After 48 Hours (C48hr) in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.
All participants 0 to <2 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
ng/mL
Approximately 48 hours (from 46 to 50 hours) post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1
Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Units
Primary
Apparent Total Body Clearance (CL/F) of Aprepitant in Participants 0 to <2 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
mL/min
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1
Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; and participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Units
Primary
Cmax of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
ng/mL
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
Tmax of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hours
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
AUC 0-∞ of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hr•ng/mL
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
AUC 0-24hr of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hr•ng/mL
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
t1/2 of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hours
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
C24hr of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.
All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
ng/mL
Approximately 24 hours (from 23 to 25 hours) post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG002
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1
Primary
C48hr of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.
All participants 2 to <6 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
ng/mL
Approximately 48 hours (from 46 to 50 hours) post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
CL/F of Aprepitant in Participants 2 to <6 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
mL/min
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
Cmax of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
ng/mL
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
Tmax of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hours
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
AUC 0-∞ of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hr•ng/mL
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
AUC 0-24hr of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hr•ng/mL
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
t1/2 of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hours
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
C24hr of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.
All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
ng/mL
Approximately 24 hours (from 23 to 25 hours) post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG002
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1
Primary
C48hr of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.
All participants 6 to <12 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
ng/mL
Approximately 48 hours (from 46 to 50 hours) post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
CL/F of Aprepitant in Participants 6 to <12 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
mL/min
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 5 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 5 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 3 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Primary
Cmax of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
ng/mL
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG002
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1
Primary
Tmax of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hours
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG002
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1
Primary
AUC 0-∞ of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hr•ng/mL
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG002
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1
Primary
AUC 0-24hr of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hr•ng/mL
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG002
Primary
t1/2 of Aprepitant in Participants 12 to 17 Years of Age Hours
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
hours
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG002
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1
Primary
C24hr of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.
All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
ng/mL
Approximately 24 hours (from 23 to 25 hours) post-infusion
ID
Title
Description
OG000
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG002
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1
Primary
C48hr of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.
All participants 12 to 17 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Approximately 48 hours (from 46 to 50 hours) post-infusion
ID
Title
Description
OG000
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG002
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1
Primary
CL/F of Aprepitant in Participants 12 to 17 Years of Age
Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.
All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.
Posted
Mean
Standard Deviation
mL/min
Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
ID
Title
Description
OG000
Fosaprepitant 3 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 150 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG001
Fosaprepitant 1.2 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 60 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG002
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1
Primary
Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycle 1
AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.
All randomized participants who received at least one dose of study treatment in Cycle 1.
Posted
Number
Percentage of participants
Up to 14 days postdose in Cycle 1
ID
Title
Description
OG000
Fosaprepitant 5 mg/Kg-Cycle 1
Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
OG001
Fosaprepitant 3 mg/Kg-Cycle 1
Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
Primary
Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycles 2-6
AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.
All randomized participants who received at least one dose of study treatment in Cycles 2-6.
Posted
Number
Percentage of participants
Up to 14 days postdose for each cycle (Cycles 2-6)
ID
Title
Description
OG000
Fosaprepitant 5 mg/Kg-Cycles 2-6
For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.
OG001
Fosaprepitant 3 mg/Kg-Cycles 2-6
For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
Time Frame
Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total)
Description
AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Fosaprepitant 0.4 mg/Kg-Cycle 1
Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
11
40
27
40
EG001
Fosaprepitant 1.2 mg/Kg-Cycle 1
Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
14
43
33
43
EG002
Fosaprepitant 3 mg/Kg-Cycle 1
Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.
12
42
32
42
EG003
Fosaprepitant 5 mg/Kg-Cycle 1
Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to <12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to <4 months old were administered 2.5 mg/kg; participants 0 to <1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
24
74
60
74
EG004
Placebo Control-Cycle 1
Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
12
35
24
35
EG005
Fosaprepitant 3 mg/Kg-Cycles 2-6
For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
46
106
69
106
EG006
Fosaprepitant 5 mg/Kg-Cycles 2-6
For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.
24
47
31
47
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG0030 events0 affected74 at risk
EG0041 events1 affected35 at risk
EG0052 events2 affected106 at risk
EG0060 events0 affected47 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0007 events7 affected40 at risk
EG00110 events10 affected43 at risk
EG0028 events7 affected42 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected42 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Thrombocytopaenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected43 at risk
EG0021 events1 affected42 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Asthenia
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Pyrexia
General disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected42 at risk
EG003
Infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0022 events2 affected42 at risk
EG003
Sepsis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Septic shock
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Skin infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Device related infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Febrile infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Viral infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Blood phosphorous decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected42 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0022 events1 affected42 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Drug level increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Decreased appetitie
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Seizure
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Febrile convulsion
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Device breakage
Product Issues
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
air embolism
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG00010 events9 affected40 at risk
EG00112 events11 affected43 at risk
EG00212 events12 affected42 at risk
EG00328 events27 affected74 at risk
EG00410 events10 affected35 at risk
EG00554 events33 affected106 at risk
EG00618 events14 affected47 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0004 events4 affected40 at risk
EG0013 events3 affected43 at risk
EG0026 events6 affected42 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0007 events7 affected40 at risk
EG00110 events10 affected43 at risk
EG00210 events9 affected42 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0009 events9 affected40 at risk
EG0017 events6 affected43 at risk
EG00211 events11 affected42 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG00011 events6 affected40 at risk
EG0016 events4 affected43 at risk
EG0026 events6 affected42 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0012 events2 affected43 at risk
EG0024 events4 affected42 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0013 events3 affected43 at risk
EG0022 events2 affected42 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0007 events6 affected40 at risk
EG0013 events3 affected43 at risk
EG0025 events4 affected42 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected42 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0012 events2 affected43 at risk
EG0022 events2 affected42 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0009 events9 affected40 at risk
EG0015 events5 affected43 at risk
EG0028 events7 affected42 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0015 events5 affected43 at risk
EG0022 events2 affected42 at risk
EG003
Pyrexia
General disorders
MedDRA 19.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0014 events3 affected43 at risk
EG0026 events5 affected42 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0004 events4 affected40 at risk
EG0012 events2 affected43 at risk
EG0022 events1 affected42 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0012 events2 affected43 at risk
EG0024 events2 affected42 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0015 events5 affected43 at risk
EG0023 events2 affected42 at risk
EG003
Platelet count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0003 events3 affected40 at risk
EG0018 events7 affected43 at risk
EG0025 events5 affected42 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 19.1
Systematic Assessment
EG0005 events5 affected40 at risk
EG0015 events3 affected43 at risk
EG0023 events2 affected42 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0022 events2 affected42 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0024 events4 affected42 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected43 at risk
EG0023 events3 affected42 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0013 events3 affected43 at risk
EG0024 events4 affected42 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected43 at risk
EG0023 events3 affected42 at risk
EG003
Headache
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0005 events3 affected40 at risk
EG0019 events6 affected43 at risk
EG0027 events4 affected42 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected43 at risk
EG0022 events1 affected42 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG00010 events2 affected40 at risk
EG0015 events3 affected43 at risk
EG0022 events2 affected42 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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 guidelines.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
ID
Term
D014839
Vomiting
Ancestor Terms
ID
Term
D012817
Signs and Symptoms, Digestive
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
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ID
Term
C579707
fosaprepitant
D000077608
Aprepitant
D007267
Injections
D017294
Ondansetron
Ancestor Terms
ID
Term
D009025
Morpholines
D010078
Oxazines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D004333
Drug Administration Routes
D004358
Drug Therapy
D013812
Therapeutics
D007093
Imidazoles
D001393
Azoles
D002227
Carbazoles
D007211
Indoles
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006575
Heterocyclic Compounds, 3-Ring
Browse Leaves
Not provided
Browse Branches
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0 subjects
FG0050 subjects
FG0060 subjects
3 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG00512 subjects
FG00637 subjects
0 subjects
FG00535 subjects
FG00669 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
Withdrawal by Parent/Guardian
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0065 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0057 subjects
FG00611 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0064 subjects
Excluded Medication
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0062 subjects
Did Not Respond To Chemotherapy Regimen
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Completed Chemotherapy Regimen
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00515 subjects
FG00624 subjects
Did Not Meet Cycle Eligibility Criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0054 subjects
FG00611 subjects
Consent Withdrawn by Participant
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
Technical Problems
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Participant Moved
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
Non-compliance With Protocol
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0056 subjects
FG0064 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
119.2
± 54.3
BG004122.5± 54.0
BG005102.4± 57.0
23
BG00319
BG00419
BG005111
Male
BG00042
BG00125
BG00221
BG00322
BG00419
BG005129
Counts
Participants
OG00022
Title
Denominators
Categories
Title
Measurements
OG0002.01± 2.10
Units
Counts
Participants
OG00016
Title
Denominators
Categories
Title
Measurements
OG00037200± 15800
Units
Counts
Participants
OG00021
Title
Denominators
Categories
Title
Measurements
OG00036800± 21800
Counts
Participants
OG00016
Title
Denominators
Categories
Title
Measurements
OG0007.94± 2.86
OG00021
Title
Denominators
Categories
Title
Measurements
OG000691± 852
Counts
Participants
OG00010
Title
Denominators
Categories
Title
Measurements
OG000352± 929
Counts
Participants
OG00016
Title
Denominators
Categories
Title
Measurements
OG00024.2± 11.9
OG002
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00025
OG0016
OG0028
OG0036
Title
Denominators
Categories
Title
Measurements
OG0004270± 2370
OG0012320± 1540
OG0022030± 1780
OG003323± 103
OG002
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00025
OG0016
OG0028
OG0036
Title
Denominators
Categories
Title
Measurements
OG0001.90± 2.16
OG0012.29± 2.14
OG0021.36± 0.868
OG0031.34± 0.771
OG002
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00020
OG0015
OG0025
OG0034
Title
Denominators
Categories
Title
Measurements
OG00046400± 18600
OG00115300± 11100
OG00216000± 9680
OG0032070± 992
OG002
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00025
OG0016
OG0028
OG0035
Title
Denominators
Categories
Title
Measurements
OG00045000± 23800
OG00121800± 22200
OG00219700± 18500
OG0031840± 742
OG002
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00020
OG0015
OG0025
OG0034
Title
Denominators
Categories
Title
Measurements
OG0009.27± 4.17
OG0016.55± 3.62
OG0027.27± 3.47
OG0036.18± 3.51
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00025
OG0016
OG0028
OG0036
Title
Denominators
Categories
Title
Measurements
OG0001060± 1020
OG001278± 398
OG002332± 430
OG0039.23± 14.8
OG002
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00020
OG0010
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG000232± 471
OG002
Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00020
OG0015
OG0025
OG0034
Title
Denominators
Categories
Title
Measurements
OG00031.8± 13.8
OG00166.2± 25.5
OG00229.6± 22.1
OG00348.5± 28.4
OG002
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00024
OG00114
OG00213
OG00312
Title
Denominators
Categories
Title
Measurements
OG0004400± 1910
OG0013550± 2460
OG0021360± 903
OG003507± 443
OG002
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00024
OG00114
OG00213
OG00312
Title
Denominators
Categories
Title
Measurements
OG0002.92± 5.09
OG0011.99± 1.62
OG0022.14± 1.96
OG0031.68± 2.46
OG002
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00013
OG0018
OG0029
OG0038
Title
Denominators
Categories
Title
Measurements
OG00055300± 11900
OG00134300± 20300
OG00210700± 5440
OG0032860± 1120
OG002
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00023
OG00114
OG00213
OG00312
Title
Denominators
Categories
Title
Measurements
OG00047400± 17300
OG00129200± 14300
OG00212000± 11000
OG0034260± 5040
OG002
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00013
OG0018
OG0029
OG0038
Title
Denominators
Categories
Title
Measurements
OG0009.77± 2.49
OG0017.69± 2.09
OG0028.23± 1.83
OG0036.58± 2.36
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00024
OG00114
OG00213
OG00312
Title
Denominators
Categories
Title
Measurements
OG0001210± 1000
OG001589± 433
OG002219± 379
OG00370.4± 136
OG002
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00011
OG0010
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG000164± 124
OG002
Fosaprepitant 1.2 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/kg: 6 to <12 Years-Cycle 1
Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00013
OG0018
OG0029
OG0038
Title
Denominators
Categories
Title
Measurements
OG00042.1± 12.7
OG00169.2± 66.4
OG00278.8± 39.1
OG00389.6± 40.9
Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00012
OG00112
OG00213
Title
Denominators
Categories
Title
Measurements
OG0003500± 972
OG0011180± 408
OG002582± 437
Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00012
OG00112
OG00213
Title
Denominators
Categories
Title
Measurements
OG0000.546± 0.144
OG0010.722± 0.608
OG0020.736± 0.561
Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG0003
OG0018
OG0029
Title
Denominators
Categories
Title
Measurements
OG00033800± 7180
OG00112300± 4660
OG0023500± 1430
Fosaprepitant 0.4 mg/kg: 12 to 17 Years-Cycle 1
Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00012
OG00112
OG00213
Title
Denominators
Categories
Title
Measurements
OG00030400± 8290
OG0019700± 4200
OG0024820± 7240
Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG0003
OG0018
OG0029
Title
Denominators
Categories
Title
Measurements
OG00010.5± 1.00
OG0017.92± 1.38
OG0028.27± 1.20
Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG00012
OG00112
OG00213
Title
Denominators
Categories
Title
Measurements
OG000735± 310
OG001142± 86.4
OG002101± 247
Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG0000
OG0010
OG0020
Participants were administered 20 mg of fosaprepitant IV. Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.
Units
Counts
Participants
OG0003
OG0018
OG0029
Title
Denominators
Categories
Title
Measurements
OG00076.2± 16.2
OG00191.7± 32.5
OG002105± 29.0
OG002
Fosaprepitant 1.2 mg/Kg-Cycle 1
Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
OG003
Fosaprepitant 0.4 mg/Kg-Cycle 1
Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to <12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.
OG004
Placebo Control-Cycle 1
Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children <6 months of age), with or without dexamethasone.