Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02302807 · OUTCOME

Minimum Observed Serum Atezolizumab Concentration (Cmin)

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] · Source last updated 2019-08-01

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

Measure
GEOMETRIC_MEAN
Unit
mcg/mL
Interval / dispersion
Standard Deviation
Time frame
Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)

What was measured

Cmin was measured for all participants that received at least one dose of Atezolizumab.

Analysis population: The PK-evaluable population is defined as patients who received atezolizumab treatment and had at least one measureable PK concentration.

Groups in this outcome

Atezolizumab

Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

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

Analysis denominator · Participants

GroupSource count
Atezolizumab467

Reported measurements

Cycle 2, day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab399
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab67.529.1Not reportedNot reportedNot reported
Cycle 3, day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab341
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab95.146.5Not reportedNot reportedNot reported
Cycle 4, day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab259
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab12256.9Not reportedNot reportedNot reported
Cycle 8, day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab156
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab15972.4Not reportedNot reportedNot reported
Cycle 16, day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab79
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab19094.7Not reportedNot reportedNot reported
Cycle 24, day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab30
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab19098.7Not reportedNot reportedNot reported
Cycle 32, day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab8
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab22387.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.1
        value
        67.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        399
      units
      Participants
    title
    Cycle 2, day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.5
        value
        95.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        341
      units
      Participants
    title
    Cycle 3, day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        56.9
        value
        122
    denoms
    1. counts
      1. group Id
        OG000
        value
        259
      units
      Participants
    title
    Cycle 4, day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        72.4
        value
        159
    denoms
    1. counts
      1. group Id
        OG000
        value
        156
      units
      Participants
    title
    Cycle 8, day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        94.7
        value
        190
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      units
      Participants
    title
    Cycle 16, day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        98.7
        value
        190
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      units
      Participants
    title
    Cycle 24, day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        87.4
        value
        223
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Cycle 32, day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      467
    units
    Participants
description
Cmin was measured for all participants that received at least one dose of Atezolizumab.
dispersion Type
Standard Deviation
groups
  1. description
    Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
    id
    OG000
    title
    Atezolizumab
param Type
GEOMETRIC_MEAN
population Description
The PK-evaluable population is defined as patients who received atezolizumab treatment and had at least one measureable PK concentration.
reporting Status
POSTED
time Frame
Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)
title
Minimum Observed Serum Atezolizumab Concentration (Cmin)
type
SECONDARY
unit Of Measure
mcg/mL

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

Preserved source evidence · Not medical advice