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NCT02603432 · OUTCOME

Maximum Plasma Concentration (Cmax) of Avelumab

A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) · Source last updated 2024-03-27

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 (mcg/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
End of avelumab infusion on Day 1 of Cycle 1, 2, 3, 5, 7, 9, 11, 13 and Day 15 of Cycle 1, 2, 3 (each cycle=28 days)

What was measured

The Lower Limit of Quantitation (LLQ) of avelumab was 0.20 micrograms (mcg)/milliliter (mL). Data for this outcome measure was not collected for reporting group "Best Supportive Care", since avelumab was not administered in this arm.

Analysis population: Avelumab pharmacokinetic (PK) parameter analysis set: all participants who received at least one dose of avelumab and who had at least one post-dose concentration measurement above the LLQ for avelumab. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'n' signifies participants evaluable for this OM at specified time points.

Groups in this outcome

Avelumab + Best Supportive Care (BSC)

Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)344

Reported measurements

Cycle 1, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)295
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)192.768.4Not reportedNot reportedNot reported
Cycle 1, Day 15

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)283
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)216.249.6Not reportedNot reportedNot reported
Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)274
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)201.554.5Not reportedNot reportedNot reported
Cycle 2, Day 15

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)262
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)208.560.2Not reportedNot reportedNot reported
Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)251
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)213.139.6Not reportedNot reportedNot reported
Cycle 3, Day 15

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)228
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)213.152.7Not reportedNot reportedNot reported
Cycle 5, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)179
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)197.567.7Not reportedNot reportedNot reported
Cycle 7, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)147
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)191.986.2Not reportedNot reportedNot reported
Cycle 9, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)111
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)168.984.4Not reportedNot reportedNot reported
Cycle 11, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)86
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)203.451.6Not reportedNot reportedNot reported
Cycle 13, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)74
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)222.830.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        68.4
        value
        192.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        295
      units
      Participants
    title
    Cycle 1, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.6
        value
        216.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        283
      units
      Participants
    title
    Cycle 1, Day 15
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.5
        value
        201.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        274
      units
      Participants
    title
    Cycle 2, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.2
        value
        208.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        262
      units
      Participants
    title
    Cycle 2, Day 15
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        39.6
        value
        213.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        251
      units
      Participants
    title
    Cycle 3, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.7
        value
        213.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        228
      units
      Participants
    title
    Cycle 3, Day 15
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.7
        value
        197.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        179
      units
      Participants
    title
    Cycle 5, Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        86.2
        value
        191.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        147
      units
      Participants
    title
    Cycle 7, Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        84.4
        value
        168.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        111
      units
      Participants
    title
    Cycle 9, Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.6
        value
        203.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        86
      units
      Participants
    title
    Cycle 11, Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.3
        value
        222.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      units
      Participants
    title
    Cycle 13, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      344
    units
    Participants
description
The Lower Limit of Quantitation (LLQ) of avelumab was 0.20 micrograms (mcg)/milliliter (mL). Data for this outcome measure was not collected for reporting group "Best Supportive Care", since avelumab was not administered in this arm.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    id
    OG000
    title
    Avelumab + Best Supportive Care (BSC)
param Type
GEOMETRIC_MEAN
population Description
Avelumab pharmacokinetic (PK) parameter analysis set: all participants who received at least one dose of avelumab and who had at least one post-dose concentration measurement above the LLQ for avelumab. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'n' signifies participants evaluable for this OM at specified time points.
reporting Status
POSTED
time Frame
End of avelumab infusion on Day 1 of Cycle 1, 2, 3, 5, 7, 9, 11, 13 and Day 15 of Cycle 1, 2, 3 (each cycle=28 days)
title
Maximum Plasma Concentration (Cmax) of Avelumab
type
SECONDARY
unit Of Measure
microgram per milliliter (mcg/mL)

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

Preserved source evidence · Not medical advice