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NCT02541604 · OUTCOME

Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Pediatric and Young Adult Participants With Solid Tumors · Source last updated 2020-02-25

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

Measure
NUMBER
Unit
Percentage
Interval / dispersion
Not reported
Time frame
PRD (0 hr) on D1 of Cy1,2,3,4,8,12,16 (1 Cy=21 days) & every 8 cycles thereafter; at any time during visit on Cy1D8, study drug discontinuation, at least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)

Analysis population: The baseline ADA-evaluable population included patients who had a baseline ADA result. The post-baseline ADA-evaluable population included patients who had at least one post-baseline ADA result and had received at least one dose of that study treatment. Patients never dosed and patients without valid ADA records were not included in the analysis.

Groups in this outcome

Atezolizumab

Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams \[mg\]) on Day 1 of each 21-day cycle.

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

Analysis denominator · Participants

GroupSource count
Atezolizumab78

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Atezolizumab78
Values in Percentage · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab2.6Not reportedNot reportedNot reportedNot reported
Post-baseline

Analysis denominator · Participants

GroupSource count
Atezolizumab77
Values in Percentage · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Atezolizumab14.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        78
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        14.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        77
      units
      Participants
    title
    Post-baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      78
    units
    Participants
groups
  1. description
    Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams \[mg\]) on Day 1 of each 21-day cycle.
    id
    OG000
    title
    Atezolizumab
param Type
NUMBER
population Description
The baseline ADA-evaluable population included patients who had a baseline ADA result. The post-baseline ADA-evaluable population included patients who had at least one post-baseline ADA result and had received at least one dose of that study treatment. Patients never dosed and patients without valid ADA records were not included in the analysis.
reporting Status
POSTED
time Frame
PRD (0 hr) on D1 of Cy1,2,3,4,8,12,16 (1 Cy=21 days) & every 8 cycles thereafter; at any time during visit on Cy1D8, study drug discontinuation, at least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)
title
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
type
PRIMARY
unit Of Measure
Percentage

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

Preserved source evidence · Not medical advice