| Primary | 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 | 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. | Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 | 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. |
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| Primary | Maximum Concentration (Cmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group | 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. | Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 | 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. |
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| Primary | Time to Maximum Concentration (Tmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group | 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. | Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour (hr) | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 1: Equivalent to 125 mg in Adults; 12 to 17 | 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. |
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| Primary | AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group | 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. | Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to <12 | 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 6 to <12 years old. |
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| Primary | Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group | 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. | Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to <12 | 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 6 to <12 years old. |
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| Primary | Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group | 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. | Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 1: Equivalent to 125 mg in Adults; 6 to <12 | 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 6 to <12 years old. |
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| Primary | AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group | 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. | Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to <6 | 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 2 to <6 years old. |
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| Primary | Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group | 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. | Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to <6 | 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 2 to <6 years old. |
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| Primary | Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group | 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. | Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 1: Equivalent to 125 mg in Adults; 2 to <6 | 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 2 to <6 years old. |
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| Primary | AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to <2 | 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 birth to <2 years old. |
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| Primary | Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to <2 | 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 birth to <2 years old. |
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| Primary | Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group | 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. | Participants aged birth to <2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 1: Equivalent to 125 mg in Adults; Birth to <2 | 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 birth to <2 years old. |
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| Primary | AUC0-last Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group | 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. | Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old. |
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| Primary | Cmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group | 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. | Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old. |
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| Primary | Tmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group | 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. | Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 2: Equivalent to 40 mg in Adults; 12 to 17 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old. |
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| Primary | AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group | 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. | Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to <12 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old. |
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| Primary | Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group | 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. | Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to <12 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old. |
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| Primary | Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group | 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. | Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 2: Equivalent to 40 mg in Adults; 6 to <12 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old. |
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| Primary | AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group | 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. | Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to <6 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old. |
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| Primary | Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group | 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. | Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to <6 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old. |
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| Primary | Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group | 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. | Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 2: Equivalent to 40 mg in Adults; 2 to <6 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old. |
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| Primary | AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to <2 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old. |
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| Primary | Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to <2 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old. |
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| Primary | Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group | 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. | Participants aged birth to <2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 2: Equivalent to 40 mg in Adults; Birth to <2 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old. |
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| Primary | AUC0-last Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group | 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. | Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old. |
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| Primary | Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group | 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. | Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old. |
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| Primary | Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group | 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. | Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 3: Equivalent to 10 mg in Adults; 12 to 17 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 12 to 17 years old. |
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| Primary | AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group | 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. | Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to <12 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old. |
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| Primary | Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group | 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. | Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to <12 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old. |
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| Primary | Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group | 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. | Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 3: Equivalent to 10 mg in Adults; 6 to <12 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 6 to <12 years old. |
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| Primary | AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group | 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. | Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to <6 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old. |
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| Primary | Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group | 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. | Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to <6 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old. |
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| Primary | Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group | 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. | Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 3: Equivalent to 10 mg in Adults; 2 to <6 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 10 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged 2 to <6 years old. |
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| Primary | AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group | 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. | Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to <2 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old. |
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| Primary | Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group | 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. | Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to <2 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old. |
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| Primary | Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group | 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. | Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | Aprepitant Dose 3: Equivalent to 10 mg in Adults; Birth to <2 | Subset of pediatric participants receiving a single dose of oral aprepitant approximating adult equivalent dose of 40 mg on Day 1 between 1 and 3 hours prior to expected induction of anesthesia that were aged birth to <2 years old. |
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| Primary | Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC0-inf) Following Administration of Single Dose | 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. | 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. | Posted | | | | | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | 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 IV immediately prior to anesthesia. | | OG001 | Aprepitant Dose 2: Equivalent to 40 mg in Adults | |
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| Primary | Apparent Total Clearance (CL/F) of Aprepitant From Plasma Following Administration of Single Dose | 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. | 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. | Posted | | | | | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | 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 IV immediately prior to anesthesia. | | OG001 | 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. |
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| Primary | Apparent Terminal Half-life (t ½) of Aprepitant Following Administration of Single Dose | 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. | 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. | Posted | | | | | | 30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration | | | | ID | Title | Description |
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| OG000 | 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 IV immediately prior to anesthesia. | | OG001 | 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. |
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| Primary | Percentage of Participants Experiencing at Least One Adverse Event (AE) | 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. | All randomized participants who received at least one dose of study treatment were analyzed. | Posted | | Number | | percentage of participants | | From pre-operative phase up to Follow-up (Day 1 to Day 15) | | | | ID | Title | Description |
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| OG000 | 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 IV immediately prior to anesthesia. | | OG001 | 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. |
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| Primary | Percentage of Participants Discontinuing Study Due to an AE | 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. | All randomized participants who received at least one dose of study treatment were analyzed. | Posted | | Number | | percentage of participants | | From pre-operative phase up to Follow-up (Day 1 to Day 15) | | | | ID | Title | Description |
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| OG000 | 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 IV immediately prior to anesthesia. | | OG001 | 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. |
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