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NCT03434379 · OUTCOME

Trough Serum Concentration (Cmin) of Atezolizumab in the China 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 China PK-evaluable population was defined as all participants in the China 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 - China

Participants in the China 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 - China132

Reported measurements

Pre-dose Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Bevacizumab - China87
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Bevacizumab - China92.665.7Not reportedNot reportedNot reported
Pre-dose Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Bevacizumab - China4
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Bevacizumab - China10536.8Not reportedNot reportedNot reported
Pre-dose Cycle 4, Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Bevacizumab - China80
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Bevacizumab - China14361.4Not reportedNot reportedNot reported
Pre-dose Cycle 8, Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Bevacizumab - China11
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Bevacizumab - China17761.9Not reportedNot reportedNot reported
Pre-dose Cycle 12, Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Bevacizumab - China20
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Bevacizumab - China20197.6Not reportedNot reportedNot reported
Pre-dose Cycle 16, Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab + Bevacizumab - China13
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab + Bevacizumab - China20879.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.7
        value
        92.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        87
      units
      Participants
    title
    Pre-dose Cycle 2, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.8
        value
        105
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Pre-dose Cycle 3, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        61.4
        value
        143
    denoms
    1. counts
      1. group Id
        OG000
        value
        80
      units
      Participants
    title
    Pre-dose Cycle 4, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        61.9
        value
        177
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Pre-dose Cycle 8, Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        97.6
        value
        201
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Pre-dose Cycle 12, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        79.4
        value
        208
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Pre-dose Cycle 16, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      132
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    OG000
    title
    Atezolizumab + Bevacizumab - China
param Type
MEAN
population Description
The China PK-evaluable population was defined as all participants in the China 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 China Population
type
SECONDARY
unit Of Measure
mcg/mL

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

Preserved source evidence · Not medical advice