Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03125902 · OUTCOME

Maximum Observed Serum Concentration (Cmax) 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
C1D1 30 min postdose

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 Paclitaxel308

Reported measurements

Source class 1
Values in μg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab and Paclitaxel32190.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        90.5
        value
        321
denoms
  1. counts
    1. group Id
      OG000
      value
      308
    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
C1D1 30 min postdose
title
Maximum Observed Serum Concentration (Cmax) 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