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NCT03434379 · OUTCOME

Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population

A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma · Source last updated 2023-10-23

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

Measure
MEAN
Unit
mcg/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)

Analysis population: The Global pharmacokinetic (PK)-evaluable population was defined as all participants in the Global population who received any dose of study treatment and who had at least one post-baseline PK sample available.

Groups in this outcome

Atezolizumab + Bevacizumab - Global

Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit 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
Atezolizumab + Bevacizumab - Global329

Reported measurements

Pre-dose Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Bevacizumab - Global298
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Bevacizumab - Global79.250.2Not reportedNot reportedNot reported
Pre-dose Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Bevacizumab - Global41
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Bevacizumab - Global10155.4Not reportedNot reportedNot reported
Pre-dose Cycle 4, Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Bevacizumab - Global263
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Bevacizumab - Global13163.7Not reportedNot reportedNot reported
Pre-dose Cycle 8, Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Bevacizumab - Global134
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Bevacizumab - Global14561.7Not reportedNot reportedNot reported
Pre-dose Cycle 12, Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Bevacizumab - Global153
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Bevacizumab - Global16882.9Not reportedNot reportedNot reported
Pre-dose Cycle 16, Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Bevacizumab - Global124
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Bevacizumab - Global16765.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.2
        value
        79.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        298
      units
      Participants
    title
    Pre-dose Cycle 2, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.4
        value
        101
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      units
      Participants
    title
    Pre-dose Cycle 3, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        63.7
        value
        131
    denoms
    1. counts
      1. group Id
        OG000
        value
        263
      units
      Participants
    title
    Pre-dose Cycle 4, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        61.7
        value
        145
    denoms
    1. counts
      1. group Id
        OG000
        value
        134
      units
      Participants
    title
    Pre-dose Cycle 8, Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        82.9
        value
        168
    denoms
    1. counts
      1. group Id
        OG000
        value
        153
      units
      Participants
    title
    Pre-dose Cycle 12, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.0
        value
        167
    denoms
    1. counts
      1. group Id
        OG000
        value
        124
      units
      Participants
    title
    Pre-dose Cycle 16, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      329
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    OG000
    title
    Atezolizumab + Bevacizumab - Global
param Type
MEAN
population Description
The Global pharmacokinetic (PK)-evaluable population was defined as all participants in the Global population who received any dose of study treatment and who had at least one post-baseline PK sample available.
reporting Status
POSTED
time Frame
Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)
title
Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
type
SECONDARY
unit Of Measure
mcg/mL

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

Preserved source evidence · Not medical advice