NCT02718417 · OUTCOME

Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (Q3W Regimen)

Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100) · Source last updated 2020-07-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: ng*hr/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2

What was measured

AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).

Analysis population: Paclitaxel PK parameter analysis set: all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on Q3W regimen and had data available for this outcome measure.

Groups in this outcome

PK: Chemotherapy Followed by Avelumab

In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.

PK: Chemotherapy + Avelumab Followed by Avelumab

In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).

PK: Chemotherapy Followed by Observation

In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
PK: Chemotherapy Followed by Avelumab	7
PK: Chemotherapy + Avelumab Followed by Avelumab	5
PK: Chemotherapy Followed by Observation	9

Reported measurements

Source class 1

Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
PK: Chemotherapy Followed by Avelumab	17540	60	Not reported	Not reported	Not reported
PK: Chemotherapy + Avelumab Followed by Avelumab	15870	21	Not reported	Not reported	Not reported
PK: Chemotherapy Followed by Observation	16390	26	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
60
value
17540
group Id
OG001
spread
21
value
15870
group Id
OG002
spread
26
value
16390

denoms

counts
group Id
OG000
value
7
group Id
OG001
value
5
group Id
OG002
value
9
units
Participants

description

AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).

dispersion Type

Geometric Coefficient of Variation

groups

description
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
id
OG000
title
PK: Chemotherapy Followed by Avelumab
description
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
id
OG001
title
PK: Chemotherapy + Avelumab Followed by Avelumab
description
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
id
OG002
title
PK: Chemotherapy Followed by Observation

param Type

GEOMETRIC_MEAN

population Description

Paclitaxel PK parameter analysis set: all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on Q3W regimen and had data available for this outcome measure.

reporting Status

POSTED

time Frame

Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2

title

Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (Q3W Regimen)

type

SECONDARY

unit Of Measure

ng*hr/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice