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NCT02603432 · OUTCOME

Predose Plasma Concentration (Ctrough) 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
Pre-dose (0 hour) 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 LLQ of avelumab was 0.20 mcg/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 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)321
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)3.1247.6Not reportedNot reportedNot reported
Cycle 1, Day 15

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)296
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)22.248.6Not reportedNot reportedNot reported
Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)268
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)25.264.2Not reportedNot reportedNot reported
Cycle 2, Day 15

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)253
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)26.565.4Not reportedNot reportedNot reported
Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)240
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)26.476.2Not reportedNot reportedNot reported
Cycle 3, Day 15

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)220
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)25.785.2Not reportedNot reportedNot reported
Cycle 5, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)183
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)26.867.5Not reportedNot reportedNot reported
Cycle 7, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)146
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)29.760.2Not 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)32.455.9Not reportedNot reportedNot reported
Cycle 11, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)90
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)29.868.9Not reportedNot reportedNot reported
Cycle 13, Day 1

Analysis denominator · Participants

GroupSource count
Avelumab + Best Supportive Care (BSC)75
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)32.454.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        247.6
        value
        3.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        321
      units
      Participants
    title
    Cycle 1, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        48.6
        value
        22.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        296
      units
      Participants
    title
    Cycle 1, Day 15
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        64.2
        value
        25.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        268
      units
      Participants
    title
    Cycle 2, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.4
        value
        26.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        253
      units
      Participants
    title
    Cycle 2, Day 15
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        76.2
        value
        26.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        240
      units
      Participants
    title
    Cycle 3, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        85.2
        value
        25.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        220
      units
      Participants
    title
    Cycle 3, Day 15
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.5
        value
        26.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        183
      units
      Participants
    title
    Cycle 5, Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.2
        value
        29.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      units
      Participants
    title
    Cycle 7, Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.9
        value
        32.4
    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
        68.9
        value
        29.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        90
      units
      Participants
    title
    Cycle 11, Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.9
        value
        32.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      units
      Participants
    title
    Cycle 13, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      344
    units
    Participants
description
The LLQ of avelumab was 0.20 mcg/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 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
Pre-dose (0 hour) 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
Predose Plasma Concentration (Ctrough) 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