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NCT02807636 · OUTCOME

Minimum Atezolizumab Serum Concentration

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma · Source last updated 2025-02-24

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
Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, Cycle 16 Day 1, Cycle 24 Day 1, Cycle 32 Day 1, Day 120 post dose of last blinded atezolizumab treatment, and study drug early discontinuation

What was measured

Minimum atezolizumab serum concentration.

Analysis population: The pharmacokinetic (PK)-evaluable population is defined as all participants dosed with atezolizumab who have at least one post-baseline PK result.

Groups in this outcome

Atezolizumab+Gemcitabine+Carboplatin/Cisplatin

Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

Atezolizumab Monotherapy

Eligible participants received open-label atezolizumab as monotherapy.

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+Gemcitabine+Carboplatin/Cisplatin382
Atezolizumab Monotherapy297

Reported measurements

Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin382
Atezolizumab Monotherapy297
Values in μg/ mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin79.852.5Not reportedNot reportedNot reported
Atezolizumab Monotherapy80.246.0Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin365
Atezolizumab Monotherapy245
Values in μg/ mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin12247.2Not reportedNot reportedNot reported
Atezolizumab Monotherapy12966.0Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin321
Atezolizumab Monotherapy183
Values in μg/ mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin15370.4Not reportedNot reportedNot reported
Atezolizumab Monotherapy15763.4Not reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin194
Atezolizumab Monotherapy104
Values in μg/ mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin21696.8Not reportedNot reportedNot reported
Atezolizumab Monotherapy19379.8Not reportedNot reportedNot reported
Cycle 16 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin40
Atezolizumab Monotherapy50
Values in μg/ mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin235103Not reportedNot reportedNot reported
Atezolizumab Monotherapy22079.8Not reportedNot reportedNot reported
Cycle 24 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin36
Atezolizumab Monotherapy29
Values in μg/ mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin24475.7Not reportedNot reportedNot reported
Atezolizumab Monotherapy23392.5Not reportedNot reportedNot reported
Cycle 32 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin17
Atezolizumab Monotherapy9
Values in μg/ mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin25997.2Not reportedNot reportedNot reported
Atezolizumab Monotherapy25860.5Not reportedNot reportedNot reported
Day 120 Post Dose of Last Blinded Atezo Trt

Analysis denominator · Participants

GroupSource count
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin67
Atezolizumab Monotherapy64
Values in μg/ mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin18.836.9Not reportedNot reportedNot reported
Atezolizumab Monotherapy9.5312.7Not reportedNot reportedNot reported
Study Drug Early Discontinuation

Analysis denominator · Participants

GroupSource count
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin194
Atezolizumab Monotherapy148
Values in μg/ mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin154102Not reportedNot reportedNot reported
Atezolizumab Monotherapy12483.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.5
        value
        79.8
      2. group Id
        OG001
        spread
        46.0
        value
        80.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        382
      2. group Id
        OG001
        value
        297
      units
      Participants
    title
    Cycle 2 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        47.2
        value
        122
      2. group Id
        OG001
        spread
        66.0
        value
        129
    denoms
    1. counts
      1. group Id
        OG000
        value
        365
      2. group Id
        OG001
        value
        245
      units
      Participants
    title
    Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        70.4
        value
        153
      2. group Id
        OG001
        spread
        63.4
        value
        157
    denoms
    1. counts
      1. group Id
        OG000
        value
        321
      2. group Id
        OG001
        value
        183
      units
      Participants
    title
    Cycle 4 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        96.8
        value
        216
      2. group Id
        OG001
        spread
        79.8
        value
        193
    denoms
    1. counts
      1. group Id
        OG000
        value
        194
      2. group Id
        OG001
        value
        104
      units
      Participants
    title
    Cycle 8 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        103
        value
        235
      2. group Id
        OG001
        spread
        79.8
        value
        220
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        50
      units
      Participants
    title
    Cycle 16 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        75.7
        value
        244
      2. group Id
        OG001
        spread
        92.5
        value
        233
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        29
      units
      Participants
    title
    Cycle 24 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        97.2
        value
        259
      2. group Id
        OG001
        spread
        60.5
        value
        258
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Cycle 32 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.9
        value
        18.8
      2. group Id
        OG001
        spread
        12.7
        value
        9.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        64
      units
      Participants
    title
    Day 120 Post Dose of Last Blinded Atezo Trt
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        102
        value
        154
      2. group Id
        OG001
        spread
        83.8
        value
        124
    denoms
    1. counts
      1. group Id
        OG000
        value
        194
      2. group Id
        OG001
        value
        148
      units
      Participants
    title
    Study Drug Early Discontinuation
denoms
  1. counts
    1. group Id
      OG000
      value
      382
    2. group Id
      OG001
      value
      297
    units
    Participants
description
Minimum atezolizumab serum concentration.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    id
    OG000
    title
    Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
  2. description
    Eligible participants received open-label atezolizumab as monotherapy.
    id
    OG001
    title
    Atezolizumab Monotherapy
param Type
MEAN
population Description
The pharmacokinetic (PK)-evaluable population is defined as all participants dosed with atezolizumab who have at least one post-baseline PK result.
reporting Status
POSTED
time Frame
Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, Cycle 16 Day 1, Cycle 24 Day 1, Cycle 32 Day 1, Day 120 post dose of last blinded atezolizumab treatment, and study drug early discontinuation
title
Minimum Atezolizumab Serum Concentration
type
SECONDARY
unit Of Measure
μg/ mL

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Preserved source evidence · Not medical advice