Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00818259
Recruitment Status : Terminated (Study terminated early prior to completing targeted enrollment of participants <6 months of age due to recruitment challenges.)
First Posted : January 7, 2009
Results First Posted : November 18, 2014
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chemotherapy-Induced Nausea and Vomiting
Interventions Drug: Experimental: aprepitant
Drug: Experimental: fosaprepitant
Drug: Comparator: ondansetron
Drug: Ondansetron
Drug: Dexamethasone
Enrollment 92
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title 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 IV-Additional Enrollers Part V-fosaprepitant Regimen Part V-Additional Enrollers
Hide Arm/Group Description Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV. 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. 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. 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. 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. 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. 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. 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. 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.
Period Title: Randomization
Started 12 11 19 20 19 0 5 0 6
Completed 12 11 19 20 19 0 5 0 6
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Part I
Started 12 [1] 11 [1] 0 0 0 0 0 0 0
Completed 11 11 0 0 0 0 0 0 0
Not Completed 1 0 0 0 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0             0             0             0             0             0
[1]
Newly enrolled participants
Period Title: Part II
Started 0 0 19 [1] 20 [1] 0 0 0 0 0
Treated 0 0 19 19 0 0 0 0 0
Completed 0 0 18 18 0 0 0 0 0
Not Completed 0 0 1 2 0 0 0 0 0
Reason Not Completed
Physician Decision             0             0             1             0             0             0             0             0             0
Lack of Efficacy             0             0             0             1             0             0             0             0             0
Not Treated             0             0             0             1             0             0             0             0             0
[1]
Newly enrolled participants
Period Title: Part III
Started 0 0 0 0 19 [1] 0 0 0 0
Completed 0 0 0 0 19 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0
[1]
Newly enrolled participants
Period Title: Part IV
Started 0 0 0 0 0 15 [1] 5 [2] 0 0
Completed 0 0 0 0 0 14 5 0 0
Not Completed 0 0 0 0 0 1 0 0 0
Reason Not Completed
Physician Decision             0             0             0             0             0             1             0             0             0
[1]
Participants continuing from Part III
[2]
Newly enrolled participants
Period Title: Part V
Started 0 0 0 0 0 0 0 17 [1] 6 [2]
Completed 0 0 0 0 0 0 0 16 6
Not Completed 0 0 0 0 0 0 0 1 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             1             0
[1]
Participants continuing from Part IV
[2]
Newly enrolled participants
Arm/Group Title 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 Total
Hide Arm/Group Description Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV. 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. 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. 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 12 11 19 20 19 5 6 92
Hide Baseline Analysis Population Description
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.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 19 participants 20 participants 19 participants 5 participants 6 participants 92 participants
6 months to <2 years 0 0 5 6 6 1 1 19
2 years to <6 years 0 0 8 8 6 0 3 25
6 years to <12 years 0 0 6 6 7 4 2 25
12 years to 17 years 12 11 0 0 0 0 0 23
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 19 participants 20 participants 19 participants 5 participants 6 participants 92 participants
Female
7
  58.3%
7
  63.6%
12
  63.2%
14
  70.0%
13
  68.4%
3
  60.0%
6
 100.0%
62
  67.4%
Male
5
  41.7%
4
  36.4%
7
  36.8%
6
  30.0%
6
  31.6%
2
  40.0%
0
   0.0%
30
  32.6%
1.Primary Outcome
Title Area Under the Time-Concentration Curve From 0 to 24 Hours (AUC 0-24hr) for Aprepitant
Hide Description AUC is a measure of the amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for pharmacokinetic (PK) assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hours (hr) post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy.
Time Frame Up to 24 hours post fosaprepitant/aprepitant dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 8 11 19 18 0 18 21
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
6 months to <2 years (n=0, 0, 5, 5, 0, 6, 6) NA [1]   (NA) NA [1]   (NA) 20000  (7890) 6310  (2040) 21100  (11800) 11700  (6980)
2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7) NA [1]   (NA) NA [1]   (NA) 16400  (8080) 23000  (8390) 17300  (5060) 18300  (11100)
6 years to <12 years (n=0, 0, 6, 6, 0, 6, 8) NA [1]   (NA) NA [1]   (NA) 16000  (4810) 22000  (9440) 24400  (15800) 19500  (6720)
12 years to 17 years (n=8, 11, 0, 0, 0, 0, 0) 19500  (8010) 30800  (7020) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Not assessed
2.Primary Outcome
Title Maximum Plasma Concentration (Cmax) for Aprepitant
Hide Description Cmax is a measure of the maximum amount of aprepitant in the plasma. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Time Frame Up to 72 hours post fosaprepitant/aprepitant dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 12 11 19 18 0 19 22
Mean (Standard Deviation)
Unit of Measure: ng/mL
6 months to <2 years (n=0, 0, 5, 5, 0, 6, 7) NA [1]   (NA) NA [1]   (NA) 1930  (1000) 659  (107) 1810  (925) 1700  (636)
2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7) NA [1]   (NA) NA [1]   (NA) 1300  (609) 2100  (1170) 1840  (933) 2430  (1100)
6 years to <12 years (n=0, 0, 6, 6, 0, 7, 8) NA [1]   (NA) NA [1]   (NA) 1300  (275) 1930  (873) 1800  (1610) 2850  (641)
12 years to 17 years (n=12, 11, 0, 0, 0, 0, 0) 3240  (1280) 5870  (2770) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Not assessed
3.Primary Outcome
Title Time to Cmax (Tmax) for Aprepitant
Hide Description Tmax is a measure of the amount of time after dosing to when the maximum concentration of aprepitant was achieved. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Time Frame Up to 72 hours post fosaprepitant/aprepitant dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 12 11 19 18 0 19 22
Mean (Standard Deviation)
Unit of Measure: hr
6 months to <2 years (n=0, 0, 5, 5, 0, 6, 7) NA [1]   (NA) NA [1]   (NA) 2.33  (1.16) 3.45  (2.89) 7.34  (8.28) 1.13  (0.17)
2 years to <6 years (n=0, 0, 8, 7, 0, 6, 7) NA [1]   (NA) NA [1]   (NA) 3.78  (1.92) 5.28  (1.97) 4.92  (2.20) 1.41  (0.83)
6 years to <12 years (n=0, 0, 6, 6, 0, 7, 8) NA [1]   (NA) NA [1]   (NA) 5.17  (1.83) 3.08  (0.95) 6.42  (7.84) 1.07  (0.11)
12 years to 17 years (n=12, 11, 0, 0, 0, 0, 0) 0.41  (0.27) 0.64  (0.30) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Not assessed
4.Primary Outcome
Title Apparent Terminal Half-life (t1/2) for Aprepitant
Hide Description t1/2 is the amount of time from dosing until half of the aprepitant was metabolized from the body. Fosaprepitant is a prodrug for aprepitant and is rapidly converted to aprepitant after IV administration. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part IB - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy; Parts II and IV - Pre-dose and 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post aprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Time Frame Up to 72 hours post fosaprepitant/aprepitant dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 11 16 13 0 12 21
Mean (Standard Deviation)
Unit of Measure: hr
6 months to <2 years (n=0, 0, 5, 3, 0, 3, 6) NA [1]   (NA) NA [1]   (NA) 7.28  (1.47) 8.09  (2.54) 6.18  (4.12) 7.71  (3.10)
2 years to <6 years (n=0, 0, 6, 4, 0, 5, 7) NA [1]   (NA) NA [1]   (NA) 8.27  (2.67) 6.06  (3.03) 9.21  (5.57) 6.44  (2.35)
6 years to <12 years (n=0, 0, 5, 6, 0, 4, 8) NA [1]   (NA) NA [1]   (NA) 9.17  (4.00) 6.89  (1.35) 10.8  (4.27) 8.76  (3.34)
12 years to 17 years (n=6 11, 0, 0, 0, 0, 0) 11.0  (4.42) 22.2  (19.8) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Not assessed
5.Primary Outcome
Title Cmax for Fosaprepitant
Hide Description Cmax is a measure of the maximum amount of fosaprepitant in the plasma. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Time Frame Up to 72 hours post fosaprepitant dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 0 11 0 0 0 0 23
Mean (Standard Deviation)
Unit of Measure: ng/mL
6 months to <2 years (n=0, 0, 0, 0, 0, 0, 7) NA [1]   (NA) 2756  (3364)
2 years to <6 years (n=0, 0, 0, 0, 0, 0, 8) NA [1]   (NA) 3034  (1718)
6 years to <12 years (n=0, 0, 0, 0, 0, 0, 8) NA [1]   (NA) 1654  (1995)
12 years to 17 years (n=0, 11, 0, 0, 0, 0, 0) 1310  (964) NA [1]   (NA)
[1]
Not assessed
6.Primary Outcome
Title Tmax for Fosaprepitant
Hide Description Tmax is a measure of the amount of time after dosing to when the maximum concentration of fosaprepitant was achieved. Blood samples for PK assessment were collected at the following time points: Part IA - Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 6, 8 and 24 hr post fosaprepitant dose; Part V - Pre-dose and -0.75, -0.5, 0, 0.5, 1.5, 3, 4, 6, 8, 24, 48 and 72 hr post start of chemotherapy.
Time Frame Up to 72 hours post fosaprepitant dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 0 11 0 0 0 0 22
Mean (Standard Deviation)
Unit of Measure: hr
6 months to <2 years (n=0, 0, 0, 0, 0, 0, 7) NA [1]   (NA) 1.13  (0.175)
2 years to <6 years (n=0, 0, 0, 0, 0, 0, 7) NA [1]   (NA) 1.05  (0.089)
6 years to <12 years (n=0, 0, 0, 0, 0, 0, 8) NA [1]   (NA) 1.04  (0.088)
12 years to 17 years (n=0, 11, 0, 0, 0, 0, 0) 0.614  (0.251) NA [1]   (NA)
[1]
Not assessed
7.Primary Outcome
Title Number of Participants Experiencing Adverse Events (AEs)
Hide Description An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for the occurrence AEs for up to 14 days after last dose of study drug.
Time Frame Up to 14 days after last dose of study drug (Up to 17 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title 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
Hide Arm/Group Description:
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 12 11 19 19 19 20 23
Measure Type: Number
Unit of Measure: Participants
11 6 18 16 15 13 17
8.Primary Outcome
Title Number of Participants Discontinuing Study Drug Due to an AE
Hide Description An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. The number of participants who discontinued from the study due to an AE are summarized.
Time Frame Day 1 up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The ASaT population consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title 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
Hide Arm/Group Description:
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 12 11 19 19 19 20 23
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0 1
9.Secondary Outcome
Title Plasma Concentration and PK Parameters of Dexamethasone in Participants From Birth to 1 Year of Age
Hide Description Blood samples for PK assessment were to be collected at the following time points: Parts II and V - Pre-dose and 1.5, 3, 4, 6, 8 and 24 hr post start of chemotherapy; Parts III and IV - Immediately after infusion of dexamethsone and 0.5, 1.5, 3, 8 and 24 hr post start of chemotherapy.
Time Frame Up to 24 hours post dexamethasone dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 14 days after last dose of study drug (Up to 17 days)
Adverse Event Reporting 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.
 
Arm/Group Title 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
Hide Arm/Group Description Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV. 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. 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. 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. 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. 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. 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.
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/12 (33.33%)      1/11 (9.09%)      7/19 (36.84%)      4/19 (21.05%)      5/19 (26.32%)      2/20 (10.00%)      9/23 (39.13%)    
Blood and lymphatic system disorders               
Febrile neutropenia  1  2/12 (16.67%)  2 0/11 (0.00%)  0 4/19 (21.05%)  4 2/19 (10.53%)  2 4/19 (21.05%)  4 2/20 (10.00%)  2 4/23 (17.39%)  4
Lymphopenia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Neutropenia  1  1/12 (8.33%)  1 0/11 (0.00%)  0 2/19 (10.53%)  2 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 2/23 (8.70%)  2
Thrombocytopenia  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  2 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Gastrointestinal disorders               
Diarrhoea  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Enteritis  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Nausea  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Vomiting  1  0/12 (0.00%)  0 0/11 (0.00%)  0 2/19 (10.53%)  2 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
General disorders               
Device dislocation  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Mucosal inflammation  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  1
Infections and infestations               
Catheter site cellulitis  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Enterobacter bacteraemia  1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Septic shock  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Vulval abscess  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Injury, poisoning and procedural complications               
Wound dehiscence  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  1
Investigations               
Neutrophil count decreased  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Metabolism and nutrition disorders               
Dehydration  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  1
Hypokalaemia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Hyponatraemia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/12 (91.67%)      5/11 (45.45%)      18/19 (94.74%)      15/19 (78.95%)      15/19 (78.95%)      13/20 (65.00%)      16/23 (69.57%)    
Blood and lymphatic system disorders               
Anaemia  1  3/12 (25.00%)  3 0/11 (0.00%)  0 0/19 (0.00%)  0 5/19 (26.32%)  5 5/19 (26.32%)  5 3/20 (15.00%)  3 3/23 (13.04%)  3
Bone marrow failure  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Coagulopathy  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Febrile neutropenia  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 2/19 (10.53%)  2 1/20 (5.00%)  1 0/23 (0.00%)  0
Leukocytosis  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Leukopenia  1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Lymphopenia  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Neutropenia  1  1/12 (8.33%)  1 0/11 (0.00%)  0 2/19 (10.53%)  2 4/19 (21.05%)  4 3/19 (15.79%)  3 3/20 (15.00%)  3 5/23 (21.74%)  5
Thrombocytopenia  1  2/12 (16.67%)  2 0/11 (0.00%)  0 0/19 (0.00%)  0 3/19 (15.79%)  3 4/19 (21.05%)  5 5/20 (25.00%)  5 4/23 (17.39%)  5
Cardiac disorders               
Sinus tachycardia  1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Tachycardia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Congenital, familial and genetic disorders               
Aplasia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Eye disorders               
Conjunctivitis  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  1
Eye irritation  1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Eye pain  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Eye pruritus  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Vision blurred  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Gastrointestinal disorders               
Abdominal pain  1  1/12 (8.33%)  2 0/11 (0.00%)  0 2/19 (10.53%)  2 4/19 (21.05%)  4 1/19 (5.26%)  1 1/20 (5.00%)  1 3/23 (13.04%)  4
Constipation  1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 3/19 (15.79%)  3 1/20 (5.00%)  1 1/23 (4.35%)  1
Diarrhoea  1  0/12 (0.00%)  0 1/11 (9.09%)  1 1/19 (5.26%)  1 1/19 (5.26%)  1 3/19 (15.79%)  3 1/20 (5.00%)  1 2/23 (8.70%)  2
Flatulence  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Gingival bleeding  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Haematemesis  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Lip blister  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Nausea  1  3/12 (25.00%)  4 0/11 (0.00%)  0 2/19 (10.53%)  3 6/19 (31.58%)  6 0/19 (0.00%)  0 1/20 (5.00%)  2 1/23 (4.35%)  1
Odynophagia  1  1/12 (8.33%)  1 0/11 (0.00%)  0 2/19 (10.53%)  2 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  1
Perianal erythema  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Retching  1  1/12 (8.33%)  1 0/11 (0.00%)  0 1/19 (5.26%)  2 1/19 (5.26%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Salivary hypersecretion  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Stomatitis  1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 3/19 (15.79%)  3 0/20 (0.00%)  0 0/23 (0.00%)  0
Tongue ulceration  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Toothache  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Vomiting  1  5/12 (41.67%)  7 0/11 (0.00%)  0 9/19 (47.37%)  23 8/19 (42.11%)  21 2/19 (10.53%)  2 1/20 (5.00%)  1 5/23 (21.74%)  7
General disorders               
Chest pain  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  1
Chills  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Fatigue  1  1/12 (8.33%)  1 1/11 (9.09%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 1/23 (4.35%)  1
Hyperthermia  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Implant site reaction  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Irritability  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 1/20 (5.00%)  1 1/23 (4.35%)  1
Mucosal inflammation  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Pain  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Product taste abnormal  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Pyrexia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 2/19 (10.53%)  2 1/19 (5.26%)  1 1/19 (5.26%)  1 1/20 (5.00%)  1 7/23 (30.43%)  8
Secretion discharge  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Hepatobiliary disorders               
Liver disorder  1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Infections and infestations               
Cystitis  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Influenza  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Nasopharyngitis  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 2/20 (10.00%)  2 1/23 (4.35%)  1
Oral bacterial infection  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Oral candidiasis  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1 0/23 (0.00%)  0
Upper respiratory tract infection  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Urinary tract infection  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Injury, poisoning and procedural complications               
Accidental overdose  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Excoriation  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Traumatic haematoma  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Investigations               
Alanine aminotranferase increased  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1 1/23 (4.35%)  1
Aspartate aminotransferase increased  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1 0/23 (0.00%)  0
Blood bicarbonate decreased  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Blood glucose increased  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Blood phosphorus decreased  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Blood potassium decreased  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Blood sodium decreased  1  1/12 (8.33%)  1 0/11 (0.00%)  0 1/19 (5.26%)  1 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Blood uric acid increased  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Body temperature increased  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Drug clearance decreased  1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Electrocardiogram QT prolonged  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Glucose urine present  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Haemoglobin decreased  1  1/12 (8.33%)  1 0/11 (0.00%)  0 1/19 (5.26%)  1 1/19 (5.26%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Lymphocyte count decreased  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 3/19 (15.79%)  4 0/20 (0.00%)  0 0/23 (0.00%)  0
Neutrophil count decreased  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 3/19 (15.79%)  3 0/20 (0.00%)  0 0/23 (0.00%)  0
Platelet count decreased  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 1/19 (5.26%)  1 3/19 (15.79%)  3 1/20 (5.00%)  1 0/23 (0.00%)  0
Red blood cell count decreased  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Staphylococcus test positive  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Weight decreased  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0 0/23 (0.00%)  0
White blood cell count decreased  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 2/19 (10.53%)  2 3/19 (15.79%)  3 0/20 (0.00%)  0 0/23 (0.00%)  0
Metabolism and nutrition disorders               
Decreased appetite  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 2/20 (10.00%)  2 1/23 (4.35%)  1
Dehydration  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 2/20 (10.00%)  2 0/23 (0.00%)  0
Hyperglycaemia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  2 0/19 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  1
Hypoalbuminaemia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 2/19 (10.53%)  2 0/19 (0.00%)  0 2/20 (10.00%)  2 1/23 (4.35%)  1
Hypocalcaemia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 2/19 (10.53%)  2 0/19 (0.00%)  0 1/20 (5.00%)  1 0/23 (0.00%)  0
Hypokalaemia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 2/19 (10.53%)  2 0/20 (0.00%)  0 0/23 (0.00%)  0
Hypomagnesaemia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 1/19 (5.26%)  1 0/19 (0.00%)  0 1/20 (5.00%)  1 0/23 (0.00%)  0
Hypophosphataemia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 1/20 (5.00%)  1 1/23 (4.35%)  1
Musculoskeletal and connective tissue disorders               
Back pain  1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  2
Myalgia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Pain in extremity  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Oncologic complication  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Nervous system disorders               
Dizziness  1  3/12 (25.00%)  3 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/20 (5.00%)  1 1/23 (4.35%)  1
Dysgeusia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Formication  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Headache  1  0/12 (0.00%)  0 0/11 (0.00%)  0 2/19 (10.53%)  4 1/19 (5.26%)  1 3/19 (15.79%)  3 1/20 (5.00%)  1 2/23 (8.70%)  2
Parosmia  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Sensory disturbance  1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Renal and urinary disorders               
Haematuria  1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  1
Reproductive system and breast disorders               
Perineal erythema  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Vaginal haemorrhage  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Asthmatic crisis  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Cough  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 2/19 (10.53%)  2 1/20 (5.00%)  1 2/23 (8.70%)  2
Dyspnoea  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Epistaxis  1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 1/23 (4.35%)  1
Oropharyngeal pain  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Skin and subcutaneous tissue disorders               
Dermatitis  1  0/12 (0.00%)  0 1/11 (9.09%)  2 0/19 (0.00%)  0 1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Night sweats  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Pruritus  1  0/12 (0.00%)  0 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 1/19 (5.26%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
Rash  1  0/12 (0.00%)  0 0/11 (0.00%)  0 2/19 (10.53%)  3 0/19 (0.00%)  0 1/19 (5.26%)  1 1/20 (5.00%)  1 0/23 (0.00%)  0
Skin fissures  1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/23 (0.00%)  0
Vascular disorders               
Hypotension  1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/19 (0.00%)  0 0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 2/23 (8.70%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00818259    
Other Study ID Numbers: 0869-134
2009_501 ( Other Identifier: Telerx Study Identifier )
First Submitted: January 6, 2009
First Posted: January 7, 2009
Results First Submitted: October 2, 2014
Results First Posted: November 18, 2014
Last Update Posted: September 25, 2018