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NCT02302807 · OUTCOME

Maximum Observed Serum Atezolizumab Concentration (Cmax)

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
30 minutes post dose on Day 1 of Cycles 1

What was measured

Cmax 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

Source class 1
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab334125Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        125
        value
        334
denoms
  1. counts
    1. group Id
      OG000
      value
      467
    units
    Participants
description
Cmax 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
30 minutes post dose on Day 1 of Cycles 1
title
Maximum Observed Serum Atezolizumab Concentration (Cmax)
type
SECONDARY
unit Of Measure
mcg/mL

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

Preserved source evidence · Not medical advice