NCT02155647 · OUTCOME

Part B: Serum Concentration at End of Infusion (CEOI) of Avelumab

Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200) · Source last updated 2024-03-13

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

Measure: GEOMETRIC_MEAN
Unit: Microgram per milliliter
Interval / dispersion: Geometric Coefficient of Variation
Time frame: At Day 1, 43 and 169

What was measured

Serum concentration at end of infusion (CEOI) of Avelumab is reported.

Analysis population: PK Analysis Set included all participants who received at least 1 dose of avelumab, and provided at least 1 measurable post-dose concentration. Here "Number analyzed" signifies those participants who were evaluable at specified time-point for this outcome measure.

Groups in this outcome

Part B: Avelumab

Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.

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
Part B: Avelumab	116

Reported measurements

Day 1

Analysis denominator · Participants

Group	Source count
Part B: Avelumab	104

Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part B: Avelumab	237	31.1	Not reported	Not reported	Not reported

Day 43

Analysis denominator · Participants

Group	Source count
Part B: Avelumab	78

Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part B: Avelumab	244	32.1	Not reported	Not reported	Not reported

Day 169

Analysis denominator · Participants

Group	Source count
Part B: Avelumab	41

Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Part B: Avelumab	255	27.7	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
31.1
value
237
denoms
counts
group Id
OG000
value
104
units
Participants
title
Day 1
categories
measurements
group Id
OG000
spread
32.1
value
244
denoms
counts
group Id
OG000
value
78
units
Participants
title
Day 43
categories
measurements
group Id
OG000
spread
27.7
value
255
denoms
counts
group Id
OG000
value
41
units
Participants
title
Day 169

denoms

counts
group Id
OG000
value
116
units
Participants

description

Serum concentration at end of infusion (CEOI) of Avelumab is reported.

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received Avelumab as first-line treatment for metastatic or distally recurrent MCC at a dose of 10 mg/kg as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
id
OG000
title
Part B: Avelumab

param Type

GEOMETRIC_MEAN

population Description

PK Analysis Set included all participants who received at least 1 dose of avelumab, and provided at least 1 measurable post-dose concentration. Here "Number analyzed" signifies those participants who were evaluable at specified time-point for this outcome measure.

reporting Status

POSTED

time Frame

At Day 1, 43 and 169

title

Part B: Serum Concentration at End of Infusion (CEOI) of Avelumab

type

SECONDARY

unit Of Measure

Microgram per milliliter

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

Preserved source evidence · Not medical advice