Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02155647 · OUTCOME

Part A: 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
MEAN
Unit
Micrograms per milliliter
Interval / dispersion
Standard Deviation
Time frame
Day 1, 43, 85, 169, 253, 337 and 421

What was measured

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

Analysis population: Pharmacokinetic analysis set consists of all participants who received at least 1 dose of avelumab, and provide at least 1 measurable post-dose concentration. Here "Number analyzed" signifies those participants who were evaluable at specified timepoints

Groups in this outcome

Part A: Avelumab

Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (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

GroupSource count
Part A: Avelumab88

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
Part A: Avelumab59
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab252129Not reportedNot reportedNot reported
Day 43

Analysis denominator · Participants

GroupSource count
Part A: Avelumab48
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab26674.2Not reportedNot reportedNot reported
Day 85

Analysis denominator · Participants

GroupSource count
Part A: Avelumab30
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab27457.7Not reportedNot reportedNot reported
Day 169

Analysis denominator · Participants

GroupSource count
Part A: Avelumab23
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab31565.0Not reportedNot reportedNot reported
Day 253

Analysis denominator · Participants

GroupSource count
Part A: Avelumab15
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab31870.1Not reportedNot reportedNot reported
Day 337

Analysis denominator · Participants

GroupSource count
Part A: Avelumab6
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab37348.3Not reportedNot reportedNot reported
Day 421

Analysis denominator · Participants

GroupSource count
Part A: Avelumab4
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab45371.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        129
        value
        252
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        74.2
        value
        266
    denoms
    1. counts
      1. group Id
        OG000
        value
        48
      units
      Participants
    title
    Day 43
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.7
        value
        274
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      units
      Participants
    title
    Day 85
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.0
        value
        315
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Day 169
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        70.1
        value
        318
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Day 253
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        48.3
        value
        373
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Day 337
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        71.5
        value
        453
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Day 421
denoms
  1. counts
    1. group Id
      OG000
      value
      88
    units
    Participants
description
Serum concentration at end of infusion (CEOI) of Avelumab is reported.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (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 A: Avelumab
param Type
MEAN
population Description
Pharmacokinetic analysis set consists of all participants who received at least 1 dose of avelumab, and provide at least 1 measurable post-dose concentration. Here "Number analyzed" signifies those participants who were evaluable at specified timepoints
reporting Status
POSTED
time Frame
Day 1, 43, 85, 169, 253, 337 and 421
title
Part A: Serum Concentration at End of Infusion (CEOI) of Avelumab
type
SECONDARY
unit Of Measure
Micrograms per milliliter

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

Preserved source evidence · Not medical advice