A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitan... | NCT00818259 | Trialant
NCT00818259
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
Sep 25, 2018Actual
Enrollment
92Actual
Phase
Phase 1
Conditions
Chemotherapy-Induced Nausea and Vomiting
Interventions
Experimental: aprepitant
Experimental: fosaprepitant
Comparator: ondansetron
Ondansetron
Dexamethasone
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT00818259
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
0869-134
Secondary IDs
ID
Type
Description
Link
2009_501
Other Identifier
Telerx Study Identifier
Brief Title
A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)
Official Title
A Multicenter, Open-Label, 5-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Pediatric Patients Receiving Emetogenic Chemotherapy
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Aug 2018
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study terminated early prior to completing targeted enrollment of participants <6 months of age due to recruitment challenges.
Expanded Access Info
No
Start Date
Feb 5, 2009Actual
Primary Completion Date
Jan 20, 2014Actual
Completion Date
Jan 20, 2014Actual
First Submitted Date
Jan 6, 2009
First Submission Date that Met QC Criteria
Jan 6, 2009
First Posted Date
Jan 7, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 2, 2014
Results First Submitted that Met QC Criteria
Nov 14, 2014
Results First Posted Date
Nov 18, 2014Estimated
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
Aug 27, 2018
Last Update Posted Date
Sep 25, 2018Actual
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
Not provided
Is FDA Regulated Device
Not provided
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
This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0 months to 17 years of age.
Detailed Description
Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after intravenous administration; the pharmacological effect of fosaprepitant is attributed to aprepitant. The birth to one year old cohort will be initiated in Parts III and IV upon completion of Part II (Steps A and B) in participants <6 months of age.
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
92Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part IA-fosaprepitant 115 mg/aprepitant
Experimental
Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Drug: Experimental: aprepitant
Drug: Experimental: fosaprepitant
Drug: Ondansetron
Drug: Dexamethasone
Part IB-fosaprepitant 150 mg
Experimental
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Drug: Experimental: fosaprepitant
Drug: Ondansetron
Drug: Dexamethasone
Part IIA-aprepitant 80 mg equiv.
Experimental
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Drug: Experimental: aprepitant
Drug: Ondansetron
Drug: Dexamethasone
Part IIB-aprepitant 125 mg equiv.
Experimental
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Experimental: aprepitant
Drug
aprepitant powder for suspension, 125 mg/sachet, PO
Part IA-fosaprepitant 115 mg/aprepitant
Part IIA-aprepitant 80 mg equiv.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant
AUC is a measure of the amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for pharmacokinetic (PK) assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hours (hr) post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy.
Up to 24 hours post fosaprepitant/aprepitant dose
Maximum Plasma Concentration (Cmax) for Aprepitant
Cmax is a measure of the maximum amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Up to 72 hours post fosaprepitant/aprepitant dose
Time to Cmax (Tmax) for Aprepitant
Tmax is a measure of the amount of time after dosing to when the maximum concentration of aprepitant was achieved. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Secondary Outcomes
Measure
Description
Time Frame
Plasma Concentration and PK Parameters of Dexamethasone in Participants From Birth to 1 Year of Age
Blood samples for PK assessment were to be collected at the following time points: Parts II and V - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts III and IV - Immediately after infusion of dexamethsone and 0.5, 1.5, 3, 8 and 24 hr post start of chemotherapy.
Up to 24 hours post dexamethasone dose
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Is 0 (at least 37 weeks gestation) to 17 years of age
Is scheduled to receive moderately to highly nausea-inducing chemotherapy or participant did not tolerate a previous chemotherapy regimen that is planned to be repeated
Is expected to receive ondansetron
Female participants who have begun menstruating must have a negative pregnancy test
Weighs ≥3.0 kg if <6 months of age, ≥6.0 kg if >6 months of age, and ≥7.5 kg if > 2 years of age
Has a pre-existing venous catheter
Exclusion Criteria:
Uses any illicit drugs or abuses alcohol
Is pregnant or breast feeding
Has a symptomatic central nervous system (CNS) tumor
Has an infection or other uncontrolled disease other than cancer
Kang HJ, Loftus S, Taylor A, DiCristina C, Green S, Zwaan CM. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in children: a randomised, double-blind, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):385-94. doi: 10.1016/S1470-2045(15)70061-6. Epub 2015 Mar 12.
Of the 92 unique participants who were enrolled and randomized in Parts I (n=23), II (n=39), III (n=19), IV (n=5) and V (n=6), 91 took part in this study. One participant randomized in Part IIB was discontinued prior to treatment.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
FG001
Periods
Title
Milestones
Reasons Not Completed
Randomization
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
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
Australia
Brazil
Canada
Colombia
France
Germany
Hungary
Israel
Mexico
Norway
Peru
Poland
Spain
Sweden
Switzerland
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
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Experimental: aprepitant
Drug: Ondansetron
Drug: Dexamethasone
Part III-ondansetron
Active Comparator
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
Drug: Comparator: ondansetron
Drug: Dexamethasone
Part IV-aprepitant regimen
Experimental
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
Drug: Experimental: aprepitant
Drug: Ondansetron
Drug: Dexamethasone
Part V-fosaprepitant regimen
Experimental
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Drug: Experimental: fosaprepitant
Drug: Ondansetron
Drug: Dexamethasone
Part IIB-aprepitant 125 mg equiv.
Part IV-aprepitant regimen
Emend
MK-0869
Experimental: fosaprepitant
Drug
fosaprepitant lyophilized powder for suspension, 115 mg/vial or 150 mg/vial, IV
Part IA-fosaprepitant 115 mg/aprepitant
Part IB-fosaprepitant 150 mg
Part V-fosaprepitant regimen
Emend injection
Fosaprepitant Dimeglumine
MK-0517
Comparator: ondansetron
Drug
ondansetron solution for infusion, IV, administered per local standard of care
Part III-ondansetron
Zofran
Ondansetron
Drug
ondansetron solution for infusion, IV, administered per local standard of care
Part IA-fosaprepitant 115 mg/aprepitant
Part IB-fosaprepitant 150 mg
Part IIA-aprepitant 80 mg equiv.
Part IIB-aprepitant 125 mg equiv.
Part IV-aprepitant regimen
Part V-fosaprepitant regimen
Dexamethasone
Drug
dexamethasone solution for infusion, IV, administered per local standard of care
Part IA-fosaprepitant 115 mg/aprepitant
Part IB-fosaprepitant 150 mg
Part IIA-aprepitant 80 mg equiv.
Part IIB-aprepitant 125 mg equiv.
Part III-ondansetron
Part IV-aprepitant regimen
Part V-fosaprepitant regimen
Up to 72 hours post fosaprepitant/aprepitant dose
Apparent Terminal Half-life (t1/2) for Aprepitant
t1/2 is the amount of time from dosing until half of the aprepitant was metabolized from the body. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Up to 72 hours post fosaprepitant/aprepitant dose
Cmax for Fosaprepitant
Cmax is a measure of the maximum amount of fosaprepitant in the plasma. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Up to 72 hours post fosaprepitant dose
Tmax for Fosaprepitant
Tmax is a measure of the amount of time after dosing to when the maximum concentration of fosaprepitant was achieved. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Up to 72 hours post fosaprepitant dose
Number of Participants Experiencing Adverse Events (AEs)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for the occurrence AEs for up to 14 days after last dose of study drug.
Up to 14 days after last dose of study drug (Up to 17 days)
Number of Participants Discontinuing Study Drug Due to an AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. The number of participants who discontinued from the study due to an AE are summarized.
Day 1 up to Day 3
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
FG002
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
FG003
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
FG004
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
FG005
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
FG006
Part IV-Additional Enrollers
Additional participants were enrolled in Part IV. Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
FG007
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
FG008
Part V-Additional Enrollers
Additional participants were enrolled in Part V. Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
FG00012 subjects
FG00111 subjects
FG00219 subjects
FG00320 subjects
FG00419 subjects
FG0050 subjects
FG0065 subjects
FG0070 subjects
FG0086 subjects
COMPLETED
FG00012 subjects
FG00111 subjects
FG00219 subjects
FG00320 subjects
FG00419 subjects
FG0050 subjects
FG0065 subjects
FG0070 subjects
FG0086 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Part I
Type
Comment
Milestone Data
STARTED
FG00012 subjectsNewly enrolled participants
FG00111 subjectsNewly enrolled participants
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
COMPLETED
FG00011 subjects
FG00111 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Part II
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00219 subjectsNewly enrolled participants
FG00320 subjectsNewly enrolled participants
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Treated
FG0000 subjects
FG0010 subjects
FG00219 subjects
FG00319 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG00218 subjects
FG00318 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Part III
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00419 subjectsNewly enrolled participants
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part IV
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00515 subjectsParticipants continuing from Part III
FG0065 subjectsNewly enrolled participants
FG0070 subjects
FG0080 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part V
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG00717 subjectsParticipants continuing from Part IV
FG0086 subjectsNewly enrolled participants
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
For analysis purposes, baseline (BL) data are presented by study part groups. The BL analysis population includes all unique enrolled participants in Parts I, II, III, IV and V. Part III participants who entered Parts IV and V are only counted in Part III; Part IV participants who entered Part V are only counted in Part IV.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
BG001
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
BG002
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
BG003
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
BG004
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
BG005
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
BG006
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00111
BG00219
BG00320
BG00419
BG0055
BG0066
BG00792
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
6 months to <2 years
Title
Measurements
BG0000
BG0010
BG0025
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0017
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
Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant
AUC is a measure of the amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for pharmacokinetic (PK) assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hours (hr) post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy.
The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.
Posted
Mean
Standard Deviation
hr*ng/mL
Up to 24 hours post fosaprepitant/aprepitant dose
ID
Title
Description
OG000
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG001
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG002
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG003
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG004
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
OG005
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
OG006
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Units
Counts
Participants
OG0008
OG00111
OG00219
OG003
Title
Denominators
Categories
6 months to <2 years (n=0, 0, 5, 5, 0, 6, 6)
Title
Measurements
OG000NA± NANot assessed
OG001NA± NANot assessed
OG00220000± 7890
Primary
Maximum Plasma Concentration (Cmax) for Aprepitant
Cmax is a measure of the maximum amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.
Posted
Mean
Standard Deviation
ng/mL
Up to 72 hours post fosaprepitant/aprepitant dose
ID
Title
Description
OG000
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG001
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Primary
Time to Cmax (Tmax) for Aprepitant
Tmax is a measure of the amount of time after dosing to when the maximum concentration of aprepitant was achieved. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.
Posted
Mean
Standard Deviation
hr
Up to 72 hours post fosaprepitant/aprepitant dose
ID
Title
Description
OG000
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG001
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Primary
Apparent Terminal Half-life (t1/2) for Aprepitant
t1/2 is the amount of time from dosing until half of the aprepitant was metabolized from the body. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
The population consisted of all participants who received at least one dose of fosaprepitant and/or aprepitant and were evaluable for this PK parameter. No PK assessements were performed on the Part III-ondansetron group; this group received no aprepitant.
Posted
Mean
Standard Deviation
hr
Up to 72 hours post fosaprepitant/aprepitant dose
ID
Title
Description
OG000
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG001
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Primary
Cmax for Fosaprepitant
Cmax is a measure of the maximum amount of fosaprepitant in the plasma. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
The population consisted of all participants who received at least one dose of fosaprepitant & were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III & Part IV groups received no fosaprepitant.
Posted
Mean
Standard Deviation
ng/mL
Up to 72 hours post fosaprepitant dose
ID
Title
Description
OG000
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG001
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Primary
Tmax for Fosaprepitant
Tmax is a measure of the amount of time after dosing to when the maximum concentration of fosaprepitant was achieved. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
The population consisted of all participants who received at least one dose of fosaprepitant & were evaluable for this PK parameter. No PK analyses were performed on the Part 1A-fosaprepitant 115 mg/aprepitant group; blood samples from this group were not handled correctly. Part IIA, Part IIB, Part III & Part IV groups received no fosaprepitant.
Posted
Mean
Standard Deviation
hr
Up to 72 hours post fosaprepitant dose
ID
Title
Description
OG000
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG001
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Primary
Number of Participants Experiencing Adverse Events (AEs)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for the occurrence AEs for up to 14 days after last dose of study drug.
The All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of study drug.
Posted
Number
Participants
Up to 14 days after last dose of study drug (Up to 17 days)
ID
Title
Description
OG000
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG001
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG002
Part IIA-aprepitant 80 mg Equiv.
Secondary
Plasma Concentration and PK Parameters of Dexamethasone in Participants From Birth to 1 Year of Age
Blood samples for PK assessment were to be collected at the following time points: Parts II and V - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts III and IV - Immediately after infusion of dexamethsone and 0.5, 1.5, 3, 8 and 24 hr post start of chemotherapy.
This population was to consist of all participants from birth to 1 year of age who received at least one dose of dexamethasone and were evaluable for this PK parameter. These analyses were not conducted; enrollment of this cohort was not opened as enrollment of participants from birth to <6 months of age into Part II was unsuccessful.
Posted
Up to 24 hours post dexamethasone dose
ID
Title
Description
OG000
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG001
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG002
Primary
Number of Participants Discontinuing Study Drug Due to an AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. The number of participants who discontinued from the study due to an AE are summarized.
The ASaT population consisted of all randomized participants who received at least one dose of study drug.
Posted
Number
Participants
Day 1 up to Day 3
ID
Title
Description
OG000
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG001
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG002
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Time Frame
Up to 14 days after last dose of study drug (Up to 17 days)
Description
The ASaT population consisted of all randomized participants who received at least one dose of study drug. Participants who completed Part III could enter Parts IV and V, and are counted once for each study part in which they participated. AEs are reported based on the study drug taken at the time of the event.
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
Part IA-fosaprepitant 115 mg/Aprepitant
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
4
12
11
12
EG001
Part IB-fosaprepitant 150 mg
Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
1
11
5
11
EG002
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
7
19
18
19
EG003
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
4
19
15
19
EG004
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
5
19
15
19
EG005
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
2
20
13
20
EG006
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
9
23
16
23
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected11 at risk
EG0024 events4 affected19 at risk
EG0032 events2 affected19 at risk
EG0044 events4 affected19 at risk
EG0052 events2 affected20 at risk
EG0064 events4 affected23 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0022 events2 affected19 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0022 events2 affected19 at risk
EG003
Device dislocation
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Catheter site cellulitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Enterobacter bacteraemia
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Septic shock
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Vulval abscess
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0003 events3 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG0035 events5 affected19 at risk
EG0045 events5 affected19 at risk
EG0053 events3 affected20 at risk
EG0063 events3 affected23 at risk
Bone marrow failure
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0022 events2 affected19 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 16.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Aplasia
Congenital, familial and genetic disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Eye irritation
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Eye pain
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Vision blurred
Eye disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0002 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0022 events2 affected19 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Lip blister
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0004 events3 affected12 at risk
EG0010 events0 affected11 at risk
EG0023 events2 affected19 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0022 events2 affected19 at risk
EG003
Perianal erythema
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0022 events1 affected19 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 16.1
Systematic Assessment
EG0007 events5 affected12 at risk
EG0010 events0 affected11 at risk
EG00223 events9 affected19 at risk
EG003
Chest pain
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Chills
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Fatigue
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Hyperthermia
General disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Implant site reaction
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Irritability
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Pain
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Product taste abnormal
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Pyrexia
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0022 events2 affected19 at risk
EG003
Secretion discharge
General disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Cystitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Influenza
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Oral bacterial infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Alanine aminotranferase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Blood bicarbonate decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Blood glucose increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Body temperature increased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Drug clearance decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Glucose urine present
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Platelet count decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Red blood cell count decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Staphylococcus test positive
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Weight decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Oncologic complication
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0003 events3 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Formication
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Headache
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0024 events2 affected19 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Perineal erythema
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Asthmatic crisis
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0021 events1 affected19 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0012 events1 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected11 at risk
EG0023 events2 affected19 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA 16.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected19 at risk
EG003
Hypotension
Vascular disorders
MedDRA 16.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected11 at risk
EG0020 events0 affected19 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.
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
Not provided
ID
Term
D000077608
Aprepitant
C579707
fosaprepitant
D017294
Ondansetron
D003907
Dexamethasone
Ancestor Terms
ID
Term
D009025
Morpholines
D010078
Oxazines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D007093
Imidazoles
D001393
Azoles
D002227
Carbazoles
D007211
Indoles
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006575
Heterocyclic Compounds, 3-Ring
D011246
Pregnadienetriols
D011245
Pregnadienes
D011278
Pregnanes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
D013259
Steroids, Fluorinated
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Not Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
19 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG00514 subjects
FG0065 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG00716 subjects
FG0086 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
6
BG0046
BG0051
BG0061
BG00719
2 years to <6 years
Title
Measurements
BG0000
BG0010
BG0028
BG0038
BG0046
BG0050
BG0063
BG00725
6 years to <12 years
Title
Measurements
BG0000
BG0010
BG0026
BG0036
BG0047
BG0054
BG0062
BG00725
12 years to 17 years
Title
Measurements
BG00012
BG00111
BG0020
BG0030
BG0040
BG0050
BG0060
BG00723
12
BG00314
BG00413
BG0053
BG0066
BG00762
Male
BG0005
BG0014
BG0027
BG0036
BG0046
BG0052
BG0060
BG00730
18
OG0040
OG00518
OG00621
OG0036310± 2040
OG00521100± 11800
OG00611700± 6980
2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7)
Title
Measurements
OG000NA± NANot assessed
OG001NA± NANot assessed
OG00216400± 8080
OG00323000± 8390
OG00517300± 5060
OG00618300± 11100
6 years to <12 years (n=0, 0, 6, 6, 0, 6, 8)
Title
Measurements
OG000NA± NANot assessed
OG001NA± NANot assessed
OG00216000± 4810
OG00322000± 9440
OG00524400± 15800
OG00619500± 6720
12 years to 17 years (n=8, 11, 0, 0, 0, 0, 0)
Title
Measurements
OG00019500± 8010
OG00130800± 7020
OG002NA± NANot assessed
OG003NA± NANot assessed
OG005NA± NANot assessed
OG006NA± NANot assessed
OG002
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG003
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG004
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
OG005
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
OG006
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Units
Counts
Participants
OG00012
OG00111
OG00219
OG00318
OG0040
OG00519
OG00622
Title
Denominators
Categories
6 months to <2 years (n=0, 0, 5, 5, 0, 6, 7)
Title
Measurements
OG000NA± NANot assessed
OG001NA± NANot assessed
OG0021930± 1000
OG003659± 107
OG0051810± 925
OG0061700± 636
2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7)
Title
Measurements
OG000NA± NANot assessed
OG001NA± NANot assessed
OG0021300± 609
OG003
6 years to <12 years (n=0, 0, 6, 6, 0, 7, 8)
Title
Measurements
OG000NA± NANot assessed
OG001NA± NANot assessed
OG0021300± 275
OG003
12 years to 17 years (n=12, 11, 0, 0, 0, 0, 0)
Title
Measurements
OG0003240± 1280
OG0015870± 2770
OG002NA± NANot assessed
OG003
OG002
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG003
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG004
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
OG005
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
OG006
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Units
Counts
Participants
OG00012
OG00111
OG00219
OG00318
OG0040
OG00519
OG00622
Title
Denominators
Categories
6 months to <2 years (n=0, 0, 5, 5, 0, 6, 7)
Title
Measurements
OG000NA± NANot assessed
OG001NA± NANot assessed
OG0022.33± 1.16
OG0033.45± 2.89
OG0057.34± 8.28
OG0061.13± 0.17
2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7)
Title
Measurements
OG000NA± NANot assessed
OG001NA± NANot assessed
OG0023.78± 1.92
OG003
6 years to <12 years (n=0, 0, 6, 6, 0, 7, 8)
Title
Measurements
OG000NA± NANot assessed
OG001NA± NANot assessed
OG0025.17± 1.83
OG003
12 years to 17 years (n=12, 11, 0, 0, 0, 0, 0)
Title
Measurements
OG0000.41± 0.27
OG0010.64± 0.30
OG002NA± NANot assessed
OG003
OG002
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG003
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG004
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
OG005
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
OG006
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Units
Counts
Participants
OG0006
OG00111
OG00216
OG00313
OG0040
OG00512
OG00621
Title
Denominators
Categories
6 months to <2 years (n=0, 0, 5, 3, 0, 3, 6)
Title
Measurements
OG000NA± NANot assessed
OG001NA± NANot assessed
OG0027.28± 1.47
OG0038.09± 2.54
OG0056.18± 4.12
OG0067.71± 3.10
2 years to <6 years (n=0, 0, 6, 4, 0, 5, 7)
Title
Measurements
OG000NA± NANot assessed
OG001NA± NANot assessed
OG0028.27± 2.67
OG003
6 years to <12 years (n=0, 0, 5, 6, 0, 4, 8)
Title
Measurements
OG000NA± NANot assessed
OG001NA± NANot assessed
OG0029.17± 4.00
OG003
12 years to 17 years (n=6 11, 0, 0, 0, 0, 0)
Title
Measurements
OG00011.0± 4.42
OG00122.2± 19.8
OG002NA± NANot assessed
OG003
OG002
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG003
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG004
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
OG005
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
OG006
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Units
Counts
Participants
OG0000
OG00111
OG0020
OG0030
OG0040
OG0050
OG00623
Title
Denominators
Categories
6 months to <2 years (n=0, 0, 0, 0, 0, 0, 7)
Title
Measurements
OG001NA± NANot assessed
OG0062756± 3364
2 years to <6 years (n=0, 0, 0, 0, 0, 0, 8)
Title
Measurements
OG001NA± NANot assessed
OG0063034± 1718
6 years to <12 years (n=0, 0, 0, 0, 0, 0, 8)
Title
Measurements
OG001NA± NANot assessed
OG0061654± 1995
12 years to 17 years (n=0, 11, 0, 0, 0, 0, 0)
Title
Measurements
OG0011310± 964
OG006NA± NANot assessed
OG002
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG003
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG004
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
OG005
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
OG006
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Units
Counts
Participants
OG0000
OG00111
OG0020
OG0030
OG0040
OG0050
OG00622
Title
Denominators
Categories
6 months to <2 years (n=0, 0, 0, 0, 0, 0, 7)
Title
Measurements
OG001NA± NANot assessed
OG0061.13± 0.175
2 years to <6 years (n=0, 0, 0, 0, 0, 0, 7)
Title
Measurements
OG001NA± NANot assessed
OG0061.05± 0.089
6 years to <12 years (n=0, 0, 0, 0, 0, 0, 8)
Title
Measurements
OG001NA± NANot assessed
OG0061.04± 0.088
12 years to 17 years (n=0, 11, 0, 0, 0, 0, 0)
Title
Measurements
OG0010.614± 0.251
OG006NA± NANot assessed
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG003
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG004
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
OG005
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
OG006
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Units
Counts
Participants
OG00012
OG00111
OG00219
OG00319
OG00419
OG00520
OG00623
Title
Denominators
Categories
Title
Measurements
OG00011
OG0016
OG00218
OG00316
OG00415
OG00513
OG00617
Part IIA-aprepitant 80 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG003
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG004
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
OG005
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
OG006
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG003
Part IIB-aprepitant 125 mg Equiv.
Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
OG004
Part III-ondansetron
Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
OG005
Part IV-aprepitant Regimen
Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
OG006
Part V-fosaprepitant Regimen
Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.