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NCT00561470 · OUTCOME

Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen · Source last updated 2012-09-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo

What was measured

Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay.

Analysis population: Immunogenicity population included all participants who were treated and tested for immunogenicity at least once post-baseline.

Groups in this outcome

Placebo/FOLFIRI

Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

Aflibercept/FOLFIRI

Participants with Metastatic Colorectal Cancer administered Aflibercept and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

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

Analysis denominator · Participants

GroupSource count
Placebo/FOLFIRI526
Aflibercept/FOLFIRI521

Reported measurements

At least one positive sample in the ADA assay
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo/FOLFIRI18Not reportedNot reportedNot reportedNot reported
Aflibercept/FOLFIRI8Not reportedNot reportedNot reportedNot reported
At least one positive sample in the NAb assay
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo/FOLFIRI2Not reportedNot reportedNot reportedNot reported
Aflibercept/FOLFIRI1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        8
    title
    At least one positive sample in the ADA assay
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    At least one positive sample in the NAb assay
denoms
  1. counts
    1. group Id
      OG000
      value
      526
    2. group Id
      OG001
      value
      521
    units
    Participants
description
Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay.
groups
  1. description
    Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
    id
    OG000
    title
    Placebo/FOLFIRI
  2. description
    Participants with Metastatic Colorectal Cancer administered Aflibercept and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
    id
    OG001
    title
    Aflibercept/FOLFIRI
param Type
NUMBER
population Description
Immunogenicity population included all participants who were treated and tested for immunogenicity at least once post-baseline.
reporting Status
POSTED
time Frame
Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo
title
Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice