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NCT02155647 · OUTCOME

Part A: Minimum Serum Post-dose (Ctrough) Concentration of Aveluamb

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 15, 29, 43, 57, 71, 85, 99, 169, 211, 253, 337 and 421

What was measured

Minimum serum post-dose (Ctrough) concentration of avelumab was 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 15

Analysis denominator · Participants

GroupSource count
Part A: Avelumab77
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab23.828.4Not reportedNot reportedNot reported
Day 29

Analysis denominator · Participants

GroupSource count
Part A: Avelumab69
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab26.413.7Not reportedNot reportedNot reported
Day 43

Analysis denominator · Participants

GroupSource count
Part A: Avelumab69
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab32.335.8Not reportedNot reportedNot reported
Day 57

Analysis denominator · Participants

GroupSource count
Part A: Avelumab56
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab32.718.8Not reportedNot reportedNot reported
Day 71

Analysis denominator · Participants

GroupSource count
Part A: Avelumab52
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab33.521.1Not reportedNot reportedNot reported
Day 85

Analysis denominator · Participants

GroupSource count
Part A: Avelumab42
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab45.553.6Not reportedNot reportedNot reported
Day 99

Analysis denominator · Participants

GroupSource count
Part A: Avelumab37
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab40.324.0Not reportedNot reportedNot reported
Day 169

Analysis denominator · Participants

GroupSource count
Part A: Avelumab24
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab43.619.6Not reportedNot reportedNot reported
Day 211

Analysis denominator · Participants

GroupSource count
Part A: Avelumab1
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab57.2Not reportedNot reportedNot reportedNot reported
Day 253

Analysis denominator · Participants

GroupSource count
Part A: Avelumab11
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab38.415.7Not reportedNot reportedNot reported
Day 337

Analysis denominator · Participants

GroupSource count
Part A: Avelumab4
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab43.923.7Not reportedNot reportedNot reported
Day 421

Analysis denominator · Participants

GroupSource count
Part A: Avelumab2
Values in Micrograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: Avelumab61.47.79Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.4
        value
        23.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        77
      units
      Participants
    title
    Day 15
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.7
        value
        26.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      units
      Participants
    title
    Day 29
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.8
        value
        32.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        69
      units
      Participants
    title
    Day 43
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.8
        value
        32.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      units
      Participants
    title
    Day 57
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.1
        value
        33.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Day 71
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        53.6
        value
        45.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        42
      units
      Participants
    title
    Day 85
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.0
        value
        40.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    Day 99
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.6
        value
        43.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Day 169
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        57.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Day 211
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.7
        value
        38.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Day 253
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.7
        value
        43.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Day 337
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.79
        value
        61.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Day 421
denoms
  1. counts
    1. group Id
      OG000
      value
      88
    units
    Participants
description
Minimum serum post-dose (Ctrough) concentration of avelumab was 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 15, 29, 43, 57, 71, 85, 99, 169, 211, 253, 337 and 421
title
Part A: Minimum Serum Post-dose (Ctrough) Concentration of Aveluamb
type
SECONDARY
unit Of Measure
Micrograms per milliliter

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

Preserved source evidence · Not medical advice