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NCT02155647 · OUTCOME

Part B: 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
GEOMETRIC_MEAN
Unit
Microgram per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421, Day 505, Day 589, Day 673

What was measured

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

GroupSource count
Part B: Avelumab116

Reported measurements

Day 15

Analysis denominator · Participants

GroupSource count
Part B: Avelumab100
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Avelumab22.257.5Not reportedNot reportedNot reported
Day 29

Analysis denominator · Participants

GroupSource count
Part B: Avelumab86
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Avelumab27.880.2Not reportedNot reportedNot reported
Day 43

Analysis denominator · Participants

GroupSource count
Part B: Avelumab76
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Avelumab27.589.4Not reportedNot reportedNot reported
Day 85

Analysis denominator · Participants

GroupSource count
Part B: Avelumab61
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Avelumab29.4130.4Not reportedNot reportedNot reported
Day 127

Analysis denominator · Participants

GroupSource count
Part B: Avelumab54
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Avelumab37.065.6Not reportedNot reportedNot reported
Day 169

Analysis denominator · Participants

GroupSource count
Part B: Avelumab45
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Avelumab45.660.3Not reportedNot reportedNot reported
Day 253

Analysis denominator · Participants

GroupSource count
Part B: Avelumab47
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Avelumab39.953.0Not reportedNot reportedNot reported
Day 337

Analysis denominator · Participants

GroupSource count
Part B: Avelumab36
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Avelumab39.537.3Not reportedNot reportedNot reported
Day 421

Analysis denominator · Participants

GroupSource count
Part B: Avelumab24
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Avelumab43.630.3Not reportedNot reportedNot reported
Day 505

Analysis denominator · Participants

GroupSource count
Part B: Avelumab14
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Avelumab41.830.4Not reportedNot reportedNot reported
Day 589

Analysis denominator · Participants

GroupSource count
Part B: Avelumab4
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Avelumab57.524.1Not reportedNot reportedNot reported
Day 673

Analysis denominator · Participants

GroupSource count
Part B: Avelumab5
Values in Microgram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part B: Avelumab44.921.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.5
        value
        22.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        100
      units
      Participants
    title
    Day 15
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        80.2
        value
        27.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        86
      units
      Participants
    title
    Day 29
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        89.4
        value
        27.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      units
      Participants
    title
    Day 43
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        130.4
        value
        29.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      units
      Participants
    title
    Day 85
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.6
        value
        37.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      units
      Participants
    title
    Day 127
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.3
        value
        45.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    Day 169
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        53.0
        value
        39.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      units
      Participants
    title
    Day 253
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        37.3
        value
        39.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Day 337
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.3
        value
        43.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Day 421
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.4
        value
        41.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Day 505
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.1
        value
        57.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Day 589
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.4
        value
        44.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Day 673
denoms
  1. counts
    1. group Id
      OG000
      value
      116
    units
    Participants
description
Minimum serum post-dose (Ctrough) concentration of avelumab was reported.
dispersion Type
Geometric Coefficient of Variation
groups
  1. 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
Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421, Day 505, Day 589, Day 673
title
Part B: Minimum Serum Post-dose (Ctrough) Concentration of Aveluamb
type
SECONDARY
unit Of Measure
Microgram per milliliter

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

Preserved source evidence · Not medical advice