Trial Outcomes & Findings for A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148) (NCT NCT00819039)
NCT ID: NCT00819039
Last Updated: 2021-01-26
Results Overview
Blood samples of 0.5 mL were collected from participants for the analysis of AUC0-48 at specified time points: pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post aprepitant single dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
98 participants
Primary outcome timeframe
Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dose
Results posted on
2021-01-26
Participant Flow
This trial was conducted at 18 trial centers: 2 in Brazil, 1 in Finland, 1 in Russia, 1 in Mexico, 4 in Spain, 6 in Turkey, and 3 in the United States.
Participant milestones
| Measure |
Part 1: Oral Aprepitant
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
27
|
25
|
|
Overall Study
COMPLETED
|
44
|
27
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Part 1: Oral Aprepitant
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
Baseline characteristics by cohort
| Measure |
Part 1: Oral Aprepitant
n=46 Participants
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
n=27 Participants
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
n=25 Participants
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
0.5 to <2 years
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Age, Customized
2 to <6 years
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age, Customized
6 to <12 years
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Customized
12 to 17 years
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post-dosePopulation: The population consisted of all participants that received at least one dose of study medication and for which AUC0-48 data were available.
Blood samples of 0.5 mL were collected from participants for the analysis of AUC0-48 at specified time points: pre-dose, and 1, 2, 3, 4, 8, 12, 24, and 48 hours post aprepitant single dose.
Outcome measures
| Measure |
Part 1: Oral Aprepitant
n=43 Participants
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1
6 months to <2 years (n=11)
|
5.97 hr*ug/ml
Standard Deviation 4.44
|
—
|
—
|
|
Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1
2 years to <6 years (n=11)
|
4.76 hr*ug/ml
Standard Deviation 3.55
|
—
|
—
|
|
Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1
6 years to <12 years (n=11)
|
6.16 hr*ug/ml
Standard Deviation 2.27
|
—
|
—
|
|
Area Under the Curve From 0-48 (AUC0-48) of Aprepitant Following a Single Oral Dose in Study Part 1
12 years to 17 years (n=10)
|
6.01 hr*ug/ml
Standard Deviation 2.53
|
—
|
—
|
PRIMARY outcome
Timeframe: 48 Hours Post-DosePopulation: The population consisted of all participants that received at least one dose of study medication and for which Cmax data were available.
Blood samples were collected from participants for the analysis of Cmax up to 48 hours after dosing.
Outcome measures
| Measure |
Part 1: Oral Aprepitant
n=43 Participants
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1
6 months to <2 years (n=11)
|
715 ng/mL
Standard Deviation 445
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1
2 years to <6 years (n=11)
|
586 ng/mL
Standard Deviation 462
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1
6 years to <12 years (n=11)
|
913 ng/mL
Standard Deviation 294
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of Aprepitant Following a Single Oral Dose in Study Part 1
12 years to 17 years (n=10)
|
520 ng/mL
Standard Deviation 230
|
—
|
—
|
PRIMARY outcome
Timeframe: 48 Hours Post-DosePopulation: The population consisted of all participants that received at least one dose of study medication and for which Tmax data were available.
Blood samples were collected from participants for the analysis of Tmax up to 48 hours after dosing.
Outcome measures
| Measure |
Part 1: Oral Aprepitant
n=43 Participants
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1
6 months to <2 years (n=11)
|
3.00 Hours
Interval 1.0 to 8.0
|
—
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1
2 years to <6 years (n=11)
|
3.00 Hours
Interval 1.03 to 12.0
|
—
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1
6 years to <12 years (n=11)
|
2.00 Hours
Interval 1.0 to 8.0
|
—
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of Aprepitant Following a Single Oral Dose in Study Part 1
12 years to 17 years (n=10)
|
3.50 Hours
Interval 1.0 to 11.98
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 Hours Post-DosePopulation: The population consisted of all participants that received at least one dose of study medication and for which C24 hr data were available.
Blood samples were collected from participants for the analysis of C24 hr at 24 hours after dosing. N/A indicates that \>50% of measurements were below the lower level of quantitaion (LLOQ).
Outcome measures
| Measure |
Part 1: Oral Aprepitant
n=43 Participants
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1
6 months to <2 years (n=11)
|
31.0 ng/mL
Standard Deviation 39.5
|
—
|
—
|
|
Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1
2 years to <6 years (n=11)
|
58.6 ng/mL
Standard Deviation 54.3
|
—
|
—
|
|
Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1
6 years to <12 years (n=11)
|
51.1 ng/mL
Standard Deviation 35.6
|
—
|
—
|
|
Plasma Concentration of Aprepitant at 24 Hours (C24 hr) Following a Single Oral Dose in Study Part 1
12 years to 17 years (n=10)
|
81.1 ng/mL
Standard Deviation 59.8
|
—
|
—
|
PRIMARY outcome
Timeframe: 48 Hours Post-DosePopulation: The population consisted of all participants that received at least one dose of study medication and for which C48 hr data were available.
The mean plasma concentration of aprepitant was evaluated in participants at 48 hours following a single oral dose.
Outcome measures
| Measure |
Part 1: Oral Aprepitant
n=10 Participants
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1
6 months to <2 years (n=11)
|
NA ng/mL
Standard Deviation NA
Data are not reported since \>50% of the measurements were below the lower limit of quantitation (LLOQ).
|
—
|
—
|
|
Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1
2 years to <6 years (n=11)
|
NA ng/mL
Standard Deviation NA
Data are not reported since \>50% of the measurements were below the lower limit of quantitation (LLOQ).
|
—
|
—
|
|
Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1
6 years to <12 years (n=11)
|
NA ng/mL
Standard Deviation NA
Data are not reported since \>50% of the measurements were below the lower limit of quantitation (LLOQ).
|
—
|
—
|
|
Plasma Concentration of Aprepitant at 48 Hours (C48 hr) Following a Single Oral Dose in Study Part 1
12 years to 17 years (n=10)
|
7.25 ng/mL
Standard Deviation 8.90
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 21 Days Post-SurgeryPopulation: The population consists of all participants that received at least one dose of study medication.
Outcome measures
| Measure |
Part 1: Oral Aprepitant
n=46 Participants
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
n=27 Participants
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
n=25 Participants
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
|
20 Participants
|
12 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: The population consists of all participants that received at least one dose of study medication.
Outcome measures
| Measure |
Part 1: Oral Aprepitant
n=46 Participants
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
n=27 Participants
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
n=25 Participants
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Number of Participants Discontinuing Study Treatment Due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 24 HoursPopulation: The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.
Outcome measures
| Measure |
Part 1: Oral Aprepitant
n=25 Participants
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
n=25 Participants
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Number of Participants With No Vomiting Up to 24 Hours Following Surgery in Study Part 2
|
20 Participants
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 24 HoursPopulation: The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.
Complete response was defined as no vomiting and no use of rescue medication in 0-24 hours post-surgery.
Outcome measures
| Measure |
Part 1: Oral Aprepitant
n=25 Participants
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
n=25 Participants
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Number of Participants With Complete Response Up to 24 Hours Following Surgery in Study Part 2
|
19 Participants
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 48 HoursPopulation: The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.
Outcome measures
| Measure |
Part 1: Oral Aprepitant
n=25 Participants
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
n=25 Participants
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Number of Participants With No Vomiting Up to 48 Hours Following Surgery Ini Study Part 2
|
18 Participants
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 48 HoursPopulation: The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.
Complete response was defined as no vomiting and no use of rescue medication in 0-48 hours post-surgery.
Outcome measures
| Measure |
Part 1: Oral Aprepitant
n=25 Participants
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
n=25 Participants
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Number of Participants With Complete Response Up to 48 Hours Following Surgery in Study Part 2
|
17 Participants
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 24 HoursPopulation: The Full Analysis Set (FAS) population was used for all efficacy evaluations and included those participants who received a full dose of active study therapy, had surgery, and had at least one post-treatment efficacy assessment.
Outcome measures
| Measure |
Part 1: Oral Aprepitant
n=25 Participants
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
n=25 Participants
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Number of Participants With Vomiting Frequency in Study Part 2
No Vomiting
|
20 Participants
|
20 Participants
|
—
|
|
Number of Participants With Vomiting Frequency in Study Part 2
1 Vomiting Episode
|
5 Participants
|
3 Participants
|
—
|
|
Number of Participants With Vomiting Frequency in Study Part 2
2 Vomiting Episodes
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Vomiting Frequency in Study Part 2
3 Vomiting Episodes
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vomiting Frequency in Study Part 2
>3 Vomiting Episodes
|
0 Participants
|
1 Participants
|
—
|
Adverse Events
Part 1: Oral Aprepitant
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Part 2: Oral Aprepitant
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: Intravenous Ondansetron
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: Oral Aprepitant
n=46 participants at risk
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
n=27 participants at risk
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
n=25 participants at risk
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Infections and infestations
Incision Site Infection
|
4.3%
2/46 • Number of events 2 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
0.00%
0/25 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/46 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
0.00%
0/25 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Anastomotic Complication
|
2.2%
1/46 • Number of events 1 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
0.00%
0/27 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
0.00%
0/25 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
Other adverse events
| Measure |
Part 1: Oral Aprepitant
n=46 participants at risk
In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Oral Aprepitant
n=27 participants at risk
In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
Part 2: Intravenous Ondansetron
n=25 participants at risk
In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
6.5%
3/46 • Number of events 4 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
7.4%
2/27 • Number of events 3 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
0.00%
0/25 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
8.7%
4/46 • Number of events 6 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
0.00%
0/27 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
0.00%
0/25 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
21.7%
10/46 • Number of events 20 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
3.7%
1/27 • Number of events 5 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
0.00%
0/25 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
|
General disorders
Chest Pain
|
0.00%
0/46 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
8.0%
2/25 • Number of events 2 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
6.5%
3/46 • Number of events 3 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
0.00%
0/27 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
8.0%
2/25 • Number of events 2 • Up to Day 21 post-surgery.
The population consisted of all study participants that received at least one dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER