Trial Outcomes & Findings for A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219) (NCT NCT01732458)

NCT ID: NCT01732458

Last Updated: 2018-09-25

Results Overview

AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using a noncompartmental analysis (NCA). The limit of quantitation (LOQ) value for this analysis was 10 ng/mL.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 229 participants
• Primary outcome timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration
• Results posted on: 2018-09-25

Participant Flow

Of 262 screened for inclusion, 229 were randomized to treatment. 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose arm that was not evaluated in this study; therefore the participant was not included in any analyses. Of remaining 228 randomized participants, 8 did not receive treatment.

Participant milestones

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.
Overall Study STARTED	60	58	58	52
Overall Study Treated	57	55	56	52
Overall Study COMPLETED	57	53	55	50
Overall Study NOT COMPLETED	3	5	3	2

Reasons for withdrawal

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.
Overall Study Lost to Follow-up	0	2	0	0
Overall Study Non-Compliance With Study Drug	0	0	1	0
Overall Study Physician Decision	1	2	2	0
Overall Study Protocol Violation	2	0	0	2
Overall Study Screen Failure	0	1	0	0

Baseline Characteristics

A Study to Evaluate Aprepitant for the Prevention of Post-Operative Nausea and Vomiting in Children (MK-0869-219)

Baseline characteristics by cohort

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults n=57 Participants Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered intravenously (IV) immediately prior to anesthesia.	Aprepitant Dose 2: Equivalent to 40 mg in Adults n=55 Participants Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults n=56 Participants Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron n=52 Participants Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.	Total n=220 Participants Total of all reporting groups
Age, Continuous	90.4 months STANDARD_DEVIATION 64.3 • n=5 Participants	87.5 months STANDARD_DEVIATION 64.6 • n=7 Participants	85.1 months STANDARD_DEVIATION 59.7 • n=5 Participants	86.0 months STANDARD_DEVIATION 65.0 • n=4 Participants	87.3 months STANDARD_DEVIATION 63.0 • n=21 Participants
Age, Customized Birth to <2 years	14 participants n=5 Participants	12 participants n=7 Participants	13 participants n=5 Participants	11 participants n=4 Participants	50 participants n=21 Participants
Age, Customized 2 years to <6 years	14 participants n=5 Participants	14 participants n=7 Participants	15 participants n=5 Participants	14 participants n=4 Participants	57 participants n=21 Participants
Age, Customized 6 years to <12 years	13 participants n=5 Participants	15 participants n=7 Participants	14 participants n=5 Participants	13 participants n=4 Participants	55 participants n=21 Participants
Age, Customized 12 years to 17 years	16 participants n=5 Participants	14 participants n=7 Participants	14 participants n=5 Participants	14 participants n=4 Participants	58 participants n=21 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	19 Participants n=7 Participants	28 Participants n=5 Participants	16 Participants n=4 Participants	86 Participants n=21 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	36 Participants n=7 Participants	28 Participants n=5 Participants	36 Participants n=4 Participants	134 Participants n=21 Participants

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.

AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using a noncompartmental analysis (NCA). The limit of quantitation (LOQ) value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Area Under the Concentration-time Curve of Aprepitant From Time 0 to the Last Measurable Concentration (AUC0-last) Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group	7120 hr*ng/mL Geometric Coefficient of Variation 33.0	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.

Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Maximum Concentration (Cmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group	1340 ng/mL Geometric Coefficient of Variation 43.9	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.

Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Time to Maximum Concentration (Tmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group	4.86 hour (hr) Geometric Coefficient of Variation 56.5	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 6 to \<12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.

AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=11 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group	10300 hr*ng/mL Geometric Coefficient of Variation 39.5	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 6 to \<12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.

Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=11 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group	1870 ng/mL Geometric Coefficient of Variation 53.0	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 6 to \<12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.

Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=11 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group	6.82 hr Geometric Coefficient of Variation 26.8	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 2 to \<6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.

AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group	12000 hr*ng/mL Geometric Coefficient of Variation 39.7	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 2 to \<6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.

Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group	2260 ng/mL Geometric Coefficient of Variation 35.7	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 2 to \<6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.

Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group	4.91 hr Geometric Coefficient of Variation 51.9	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged birth to \<2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. Two participants were excluded from the analysis, due to a missing 8-hour post-dose sample and aprepitant concentration in the pre-dose sample, respectively.

AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=8 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group	6410 hr*ng/mL Geometric Coefficient of Variation 67.8	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged birth to \<2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due to aprepitant concentration in the pre-dose sample.

Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=9 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group	1280 ng/mL Geometric Coefficient of Variation 78.5	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged birth to \<2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.

Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group	4.71 hr Geometric Coefficient of Variation 51.3	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.

AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=11 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
AUC0-last Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group	2570 hr*ng/mL Geometric Coefficient of Variation 41.5	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.

Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=11 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Cmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group	513 ng/mL Geometric Coefficient of Variation 41.6	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.

Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=11 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Tmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group	4.17 hr Geometric Coefficient of Variation 69.4	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 6 to \<12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.

AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=11 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group	4730 hr*ng/mL Geometric Coefficient of Variation 60.7	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 6 to \<12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.

Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=11 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group	930 ng/mL Geometric Coefficient of Variation 66.7	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 6 to \<12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.

Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=11 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group	4.22 hr Geometric Coefficient of Variation 53.4	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 2 to \<6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.

AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=9 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group	6320 hr*ng/mL Geometric Coefficient of Variation 78.1	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 2 to \<6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.

Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=9 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group	1290 ng/mL Geometric Coefficient of Variation 81.7	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 2 to \<6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.

Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=9 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group	3.35 hr Geometric Coefficient of Variation 43.0	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged birth to \<2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.

AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=6 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group	7910 hr*ng/mL Geometric Coefficient of Variation 153.2	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged birth to \<2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.

Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=6 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group	1570 ng/mL Geometric Coefficient of Variation 146.3	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged birth to \<2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.

Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=7 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group	4.94 hr Geometric Coefficient of Variation 38.0	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.

AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
AUC0-last Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group	806 hr*ng/mL Geometric Coefficient of Variation 51.9	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.

Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group	131 ng/mL Geometric Coefficient of Variation 50.8	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.

Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group	3.53 hr Geometric Coefficient of Variation 54.1	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 6 to \<12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.

AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group	1390 hr*ng/mL Geometric Coefficient of Variation 77.0	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 6 to \<12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.

Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group	289 ng/mL Geometric Coefficient of Variation 128.4	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 6 to \<12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.

Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group	3.75 hr Geometric Coefficient of Variation 57.9	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 2 to \<6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.

AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group	1580 hr*ng/mL Geometric Coefficient of Variation 45.2	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 2 to \<6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.

Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group	300 ng/mL Geometric Coefficient of Variation 49.9	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged 2 to \<6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.

Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group	3.36 hr Geometric Coefficient of Variation 45.8	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged birth to \<2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.

AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group	1800 hr*ng/mL Geometric Coefficient of Variation 107.8	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged birth to \<2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.

Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group	336 ng/mL Geometric Coefficient of Variation 112.0	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Participants aged birth to \<2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.

Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=10 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group	4.11 hr Geometric Coefficient of Variation 48.2	—	—	—

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. AUC0-inf) was not possible.

Plasma for aprepitant AUC0-inf assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. AUC0-inf data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. CL/F) was not possible.

Plasma for aprepitant CL/F assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. CL/F data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration

Population: Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. t ½) was not possible.

Plasma for aprepitant t ½ assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. t ½ data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From pre-operative phase up to Follow-up (Day 1 to Day 15)

Population: All randomized participants who received at least one dose of study treatment were analyzed.

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants experiencing ≥1 AE was reported by dose group.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=57 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults n=55 Participants Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults n=56 Participants Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron n=52 Participants Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Percentage of Participants Experiencing at Least One Adverse Event (AE)	31.6 percentage of participants	43.6 percentage of participants	35.7 percentage of participants	48.1 percentage of participants

PRIMARY outcome

Timeframe: From pre-operative phase up to Follow-up (Day 1 to Day 15)

Population: All randomized participants who received at least one dose of study treatment were analyzed.

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants discontinuing study due to an AE was reported by dose group.

Outcome measures

Measure	Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 n=57 Participants Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 125 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old.	Aprepitant Dose 2: Equivalent to 40 mg in Adults n=55 Participants Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant Dose 3: Equivalent to 10 mg in Adults n=56 Participants Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron n=52 Participants Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia
Percentage of Participants Discontinuing Study Due to an AE	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

Adverse Events

Aprepitant 125 mg Adult Equivalent (Dose 1)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Aprepitant 40 mg Adult Equivalent (Dose 2)

Serious events: 6 serious events

Other events: 11 other events

Deaths: 0 deaths

Aprepitant 10 mg Adult Equivalent (Dose 3)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Ondansetron

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aprepitant 125 mg Adult Equivalent (Dose 1) n=57 participants at risk Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant 40 mg Adult Equivalent (Dose 2) n=55 participants at risk Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant 10 mg Adult Equivalent (Dose 3) n=56 participants at risk Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron n=52 participants at risk Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/57 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	1.8% 1/55 • Number of events 1 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/56 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/52 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.
Infections and infestations Bronchiolitis	0.00% 0/57 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/55 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	1.8% 1/56 • Number of events 1 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/52 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/57 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	5.5% 3/55 • Number of events 3 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/56 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/52 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/57 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/55 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/56 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	1.9% 1/52 • Number of events 1 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.
Renal and urinary disorders Bladder perforation	0.00% 0/57 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	1.8% 1/55 • Number of events 1 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/56 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/52 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.
Reproductive system and breast disorders Male genital tract fistula	0.00% 0/57 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/55 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/56 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	1.9% 1/52 • Number of events 1 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/57 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	1.8% 1/55 • Number of events 1 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/56 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/52 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.
Vascular disorders Thrombosis	0.00% 0/57 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	1.8% 1/55 • Number of events 1 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/56 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/52 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.

Other adverse events

Measure	Aprepitant 125 mg Adult Equivalent (Dose 1) n=57 participants at risk Pediatric participants received a single dose of apprepitant that was equivalent to 125 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant 40 mg Adult Equivalent (Dose 2) n=55 participants at risk Pediatric participants received a single dose of apprepitant that was equivalent to 40 mg in adults on Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Aprepitant 10 mg Adult Equivalent (Dose 3) n=56 participants at risk Pediatric participants received a single dose of apprepitant that was equivalent to 10 mg in adults Day 1 between 1 and 3 hours prior to expected induction of anesthesia, plus placebo for odansetron administered IV immediately prior to anesthesia.	Ondansetron n=52 participants at risk Pediatric participants in the control regimen were administered ondansetron IV on Day 1 immediately prior to induction of anesthesia plus a matching placebo dose to aprepitant as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia.
Gastrointestinal disorders Abdominal pain	5.3% 3/57 • Number of events 6 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	5.5% 3/55 • Number of events 4 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	7.1% 4/56 • Number of events 6 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	7.7% 4/52 • Number of events 6 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.
Gastrointestinal disorders Vomiting	3.5% 2/57 • Number of events 3 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	5.5% 3/55 • Number of events 3 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	3.6% 2/56 • Number of events 3 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	7.7% 4/52 • Number of events 6 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.
General disorders Pyrexia	5.3% 3/57 • Number of events 5 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	1.8% 1/55 • Number of events 1 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	5.4% 3/56 • Number of events 5 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/52 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/57 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	0.00% 0/55 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	1.8% 1/56 • Number of events 1 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	5.8% 3/52 • Number of events 3 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.
Injury, poisoning and procedural complications Procedural pain	7.0% 4/57 • Number of events 8 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	7.3% 4/55 • Number of events 4 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	5.4% 3/56 • Number of events 3 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.	9.6% 5/52 • Number of events 6 • From pre-operative phase up to Follow-up (up to 17 days) All randomized participants who received at least one dose of study treatment were analyzed (N=220). 1 participant was inadvertently randomized to a 2.5 mg aprepitant dose group which was not assessed for overall efficacy and safety, thus participant was not included in this safety analysis.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

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. SPONSOR review can be expedited to meet publication timelines.
• Publication restrictions are in place

Restriction type: OTHER