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NCT03125902 · OUTCOME

Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) · Source last updated 2024-03-26

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

Measure
MEAN
Unit
μg/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months).

Analysis population: PK-evaluable population: all participants who received any dose of Atezolizumab and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.

Groups in this outcome

Atezolizumab and Paclitaxel

Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

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 Paclitaxel342

Reported measurements

C2D1 predose

Analysis denominator · Participants

GroupSource count
Atezolizumab and Paclitaxel316
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab and Paclitaxel13953.3Not reportedNot reportedNot reported
C3D1 predose

Analysis denominator · Participants

GroupSource count
Atezolizumab and Paclitaxel277
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab and Paclitaxel20878.3Not reportedNot reportedNot reported
C4D1 predose

Analysis denominator · Participants

GroupSource count
Atezolizumab and Paclitaxel243
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab and Paclitaxel24284.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        53.3
        value
        139
    denoms
    1. counts
      1. group Id
        OG000
        value
        316
      units
      Participants
    title
    C2D1 predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        78.3
        value
        208
    denoms
    1. counts
      1. group Id
        OG000
        value
        277
      units
      Participants
    title
    C3D1 predose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        84.8
        value
        242
    denoms
    1. counts
      1. group Id
        OG000
        value
        243
      units
      Participants
    title
    C4D1 predose
denoms
  1. counts
    1. group Id
      OG000
      value
      342
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Atezolizumab and Paclitaxel
param Type
MEAN
population Description
PK-evaluable population: all participants who received any dose of Atezolizumab and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.
reporting Status
POSTED
time Frame
Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months).
title
Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population
type
SECONDARY
unit Of Measure
μg/mL

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

Preserved source evidence · Not medical advice