NCT02580058 · OUTCOME

Serum Maximum Concentration (Cmax) For Avelumab 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: mcg/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: At postdose (end of infusion, 1H) on Cycle 2 Day 1

What was measured

Cmax was defined as maximum observed serum concentration, and can be observed directly from data.

Analysis population: The PK parameter analysis set was defined as participants in the safety analysis set who had at least 1 post-dose concentration measurement above the LLQ for avelumab.

Groups in this outcome

Avelumab

Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) 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
Avelumab	104
Avelumab + PLD	110

Reported measurements

Source class 1

Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Avelumab	231.6	43	Not reported	Not reported	Not reported
Avelumab + PLD	207.9	71	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
79.5
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
101.5
group Description
Avelumab 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
90

Complete source fields

analyses

ci Lower Limit
79.5
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
101.5
group Description
Avelumab 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
90

classes

categories
measurements
group Id
OG000
spread
43
value
231.6
group Id
OG001
spread
71
value
207.9

denoms

counts
group Id
OG000
value
104
group Id
OG001
value
110
units
Participants

description

Cmax was defined as maximum observed serum concentration, and can be observed directly from data.

dispersion Type

Geometric Coefficient of Variation

groups

description
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
id
OG000
title
Avelumab
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 participants in the safety analysis set who had at least 1 post-dose concentration measurement above the LLQ for avelumab.

reporting Status

POSTED

time Frame

At postdose (end of infusion, 1H) on Cycle 2 Day 1

title

Serum Maximum Concentration (Cmax) For Avelumab Following Cycle 2 Day 1 PLD Dose

type

SECONDARY

unit Of Measure

mcg/mL

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

Preserved source evidence · Not medical advice