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NCT02425891 · OUTCOME

Minimum Serum Concentration (Cmin) for Atezolizumab

A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) · Source last updated 2022-07-19

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
Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days)

What was measured

Minimum serum concentration for atezolizumab.

Analysis population: The pharmacokinetic (PK)-evaluable population is defined as all patients who received any dose of study medication and who have at least one post-baseline PK sample available.

Groups in this outcome

Atezolizumab Plus Nab-Paclitaxel

Participants assigned to atezolizumab plus nab-paclitaxel received both agents 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 Plus Nab-Paclitaxel420

Reported measurements

Cycle 1 Day 27

Analysis denominator · Participants

GroupSource count
Atezolizumab Plus Nab-Paclitaxel420
Values in µg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab Plus Nab-Paclitaxel14552.6Not reportedNot reportedNot reported
Cycle 2 Day 27

Analysis denominator · Participants

GroupSource count
Atezolizumab Plus Nab-Paclitaxel373
Values in µg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab Plus Nab-Paclitaxel21578.3Not reportedNot reportedNot reported
Cycle 3 Day 27

Analysis denominator · Participants

GroupSource count
Atezolizumab Plus Nab-Paclitaxel343
Values in µg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab Plus Nab-Paclitaxel24590.3Not reportedNot reportedNot reported
Cycle 7 Day 27

Analysis denominator · Participants

GroupSource count
Atezolizumab Plus Nab-Paclitaxel188
Values in µg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab Plus Nab-Paclitaxel274111Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.6
        value
        145
    denoms
    1. counts
      1. group Id
        OG000
        value
        420
      units
      Participants
    title
    Cycle 1 Day 27
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        78.3
        value
        215
    denoms
    1. counts
      1. group Id
        OG000
        value
        373
      units
      Participants
    title
    Cycle 2 Day 27
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        90.3
        value
        245
    denoms
    1. counts
      1. group Id
        OG000
        value
        343
      units
      Participants
    title
    Cycle 3 Day 27
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        111
        value
        274
    denoms
    1. counts
      1. group Id
        OG000
        value
        188
      units
      Participants
    title
    Cycle 7 Day 27
denoms
  1. counts
    1. group Id
      OG000
      value
      420
    units
    Participants
description
Minimum serum concentration for atezolizumab.
dispersion Type
Standard Deviation
groups
  1. description
    Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Atezolizumab Plus Nab-Paclitaxel
param Type
MEAN
population Description
The pharmacokinetic (PK)-evaluable population is defined as all patients who received any dose of study medication and who have at least one post-baseline PK sample available.
reporting Status
POSTED
time Frame
Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days)
title
Minimum Serum Concentration (Cmin) for Atezolizumab
type
SECONDARY
unit Of Measure
µg/mL

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

Preserved source evidence · Not medical advice