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NCT02008227 · OUTCOME

Minimum Observed Serum Atezolizumab Concentration (Cmin)

A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy · Source last updated 2019-12-20

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
Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)

Analysis population: PK evaluable participants. Here, 'n' signifies those participants evaluated for this measure at specific time point. All 606 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Groups in this outcome

Atezolizumab

Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Atezolizumab606

Reported measurements

C1D1 (n= 593)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab2.5930.9Not reportedNot reportedNot reported
C2D1 (n= 534)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab83.231.0Not reportedNot reportedNot reported
C3D1 (n= 445)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab13055.8Not reportedNot reportedNot reported
C4D1 (n= 405)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab15866.4Not reportedNot reportedNot reported
C8D1 (n= 222)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab20599.4Not reportedNot reportedNot reported
C16D1 (n= 132)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab226105Not reportedNot reportedNot reported
C24D1 (n= 63)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab25099.8Not reportedNot reportedNot reported
C32D1 (n= 11)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab277117Not reportedNot reportedNot reported
EOT (n= 347)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab144101Not reportedNot reportedNot reported
120 days after EOT (n= 124)
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab10.420.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.9
        value
        2.59
    title
    C1D1 (n= 593)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.0
        value
        83.2
    title
    C2D1 (n= 534)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.8
        value
        130
    title
    C3D1 (n= 445)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        66.4
        value
        158
    title
    C4D1 (n= 405)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        99.4
        value
        205
    title
    C8D1 (n= 222)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        105
        value
        226
    title
    C16D1 (n= 132)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        99.8
        value
        250
    title
    C24D1 (n= 63)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        117
        value
        277
    title
    C32D1 (n= 11)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        101
        value
        144
    title
    EOT (n= 347)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.0
        value
        10.4
    title
    120 days after EOT (n= 124)
denoms
  1. counts
    1. group Id
      OG000
      value
      606
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
    id
    OG000
    title
    Atezolizumab
param Type
MEAN
population Description
PK evaluable participants. Here, 'n' signifies those participants evaluated for this measure at specific time point. All 606 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
reporting Status
POSTED
time Frame
Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)
title
Minimum Observed Serum Atezolizumab Concentration (Cmin)
type
SECONDARY
unit Of Measure
mcg/mL

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Preserved source evidence · Not medical advice