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NCT03498716 · OUTCOME

Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer · Source last updated 2024-08-21

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Up to 5 years

What was measured

Baseline evaluable participant= participant with an ADA assay result from a baseline sample(s). Post-baseline evaluable participant= participant with an ADA assay result from at least one postbaseline sample.

Analysis population: Safety Evaluable Population included all participants who received any amount of any study drug. Number analyzed at baseline and postbaseline are unique number of participants out of all the assessed participants who may have been ADA positive at that timepoint. Different participants may have contributed data for baseline and postbaseline.

Groups in this outcome

Atezolizumab and Chemotherapy

Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m\^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.

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

Analysis denominator · Participants

GroupSource count
Atezolizumab and Chemotherapy1093

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Atezolizumab and Chemotherapy899
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab and Chemotherapy2.1Not reportedNot reportedNot reportedNot reported
Post-baseline

Analysis denominator · Participants

GroupSource count
Atezolizumab and Chemotherapy901
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab and Chemotherapy11.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        899
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        11.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        901
      units
      Participants
    title
    Post-baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      1093
    units
    Participants
description
Baseline evaluable participant= participant with an ADA assay result from a baseline sample(s). Post-baseline evaluable participant= participant with an ADA assay result from at least one postbaseline sample.
groups
  1. description
    Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m\^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.
    id
    OG000
    title
    Atezolizumab and Chemotherapy
param Type
NUMBER
population Description
Safety Evaluable Population included all participants who received any amount of any study drug. Number analyzed at baseline and postbaseline are unique number of participants out of all the assessed participants who may have been ADA positive at that timepoint. Different participants may have contributed data for baseline and postbaseline.
reporting Status
POSTED
time Frame
Up to 5 years
title
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice