NCT02580058 · OUTCOME

Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose

A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200) · Source last updated 2023-07-10

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

Measure: GEOMETRIC_MEAN
Unit: nanogram*hour per milliliter (ng*hr/mL)
Interval / dispersion: Geometric Coefficient of Variation
Time frame: From 0 through 24 hours postdose

What was measured

AUC24 was defined as area under the concentration time profile from time zero to 24 hours.

Analysis population: The PK parameter analysis set was defined as a subset of the safety analysis set and included patients who had at least one of the PK parameters of interest for doxorubicin.

Groups in this outcome

Pegylated Liposomal Doxorubicin (PLD)

PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.

Avelumab + PLD

Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week 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
Pegylated Liposomal Doxorubicin (PLD)	14
Avelumab + PLD	14

Reported measurements

Source class 1

Values in nanogram*hour per milliliter (ng*hr/mL) · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Pegylated Liposomal Doxorubicin (PLD)	567600	11	Not reported	Not reported	Not reported
Avelumab + PLD	541700	14	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
88
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
104
group Description
PLD was the Reference treatment and Avelumab + PLD was the Test treatment.
group Ids
OG000
OG001
non Inferiority Type
OTHER
param Type
Geometric Mean Ratio (Test/Reference, %)
param Value
95

Complete source fields

analyses

ci Lower Limit
88
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
104
group Description
PLD was the Reference treatment and Avelumab + PLD was the Test treatment.
group Ids
OG000
OG001
non Inferiority Type
OTHER
param Type
Geometric Mean Ratio (Test/Reference, %)
param Value
95

classes

categories
measurements
group Id
OG000
spread
11
value
567600
group Id
OG001
spread
14
value
541700

denoms

counts
group Id
OG000
value
14
group Id
OG001
value
14
units
Participants

description

AUC24 was defined as area under the concentration time profile from time zero to 24 hours.

dispersion Type

Geometric Coefficient of Variation

groups

description
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
id
OG000
title
Pegylated Liposomal Doxorubicin (PLD)
description
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
id
OG001
title
Avelumab + PLD

param Type

GEOMETRIC_MEAN

population Description

The PK parameter analysis set was defined as a subset of the safety analysis set and included patients who had at least one of the PK parameters of interest for doxorubicin.

reporting Status

POSTED

time Frame

From 0 through 24 hours postdose

title

Area Under The Concentration Time Profile From Time Zero to 24 Hours (AUC24) For Doxorubicin Following Cycle 2 Day 1 PLD Dose

type

SECONDARY

unit Of Measure

nanogram*hour per milliliter (ng*hr/mL)

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

Preserved source evidence · Not medical advice