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NCT02603432 · OUTCOME

Number of ADA Ever Positive Participants For Each Serum of ADA Titers for 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)

What was measured

Serum samples were assayed for ADA using a validated analytical method. Number of ADA ever positive participants for each serum of ADA titer (60, 180, 540, 1620, 4860, 14580, and 131220) are reported.

Analysis population: The immunogenicity analysis set included participants who had received at least one dose of study drug and who had ADA ever-positive results. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.

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)66

Reported measurements

Source class 1

60

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)4Not reportedNot reportedNot reportedNot reported

180

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)14Not reportedNot reportedNot reportedNot reported

540

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)19Not reportedNot reportedNot reportedNot reported

1620

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)10Not reportedNot reportedNot reportedNot reported

4860

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)11Not reportedNot reportedNot reportedNot reported

14580

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)7Not reportedNot reportedNot reportedNot reported

131220

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Best Supportive Care (BSC)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      title
      60
    2. measurements
      1. group Id
        OG000
        value
        14
      title
      180
    3. measurements
      1. group Id
        OG000
        value
        19
      title
      540
    4. measurements
      1. group Id
        OG000
        value
        10
      title
      1620
    5. measurements
      1. group Id
        OG000
        value
        11
      title
      4860
    6. measurements
      1. group Id
        OG000
        value
        7
      title
      14580
    7. measurements
      1. group Id
        OG000
        value
        1
      title
      131220
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    units
    Participants
description
Serum samples were assayed for ADA using a validated analytical method. Number of ADA ever positive participants for each serum of ADA titer (60, 180, 540, 1620, 4860, 14580, and 131220) are reported.
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
COUNT_OF_PARTICIPANTS
population Description
The immunogenicity analysis set included participants who had received at least one dose of study drug and who had ADA ever-positive results. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
reporting Status
POSTED
time Frame
From randomization up to the 30-Day Follow-up visit (maximum duration of up to approximately 68 months)
title
Number of ADA Ever Positive Participants For Each Serum of ADA Titers for Avelumab
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice