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NCT02409342 · OUTCOME

Minimum Observed Serum Concentration (Cmin) of Atezolizumab

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110] · Source last updated 2023-03-15

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

Measure
MEAN
Unit
micrograms per milliliter (μg/ mL)
Interval / dispersion
Standard Deviation
Time frame
Prior to infusion (0 hour) on Day 1 of Cycles 2, 3, 4, 8, 16, and every eighth cycle thereafter, and at treatment discontinuation until data cut-off on 10 September 2018 (up to approximately 38 months) (cycle duration = 21 days)

Analysis population: PK analyses was based on PK observations from all randomized participants who received atezolizumab and provided at least one PK sample that was evaluable.

Groups in this outcome

Atezolizumab

Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).

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

Analysis denominator · Participants

GroupSource count
Atezolizumab256

Reported measurements

Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab256
Values in micrograms per milliliter (μg/ mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab76.757.6Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab215
Values in micrograms per milliliter (μg/ mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab12157.7Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab207
Values in micrograms per milliliter (μg/ mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab15490.1Not reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab145
Values in micrograms per milliliter (μg/ mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab20198.6Not reportedNot reportedNot reported
Cycle 16 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab67
Values in micrograms per milliliter (μg/ mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab213102Not reportedNot reportedNot reported
Cycle 24 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab31
Values in micrograms per milliliter (μg/ mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab245128Not reportedNot reportedNot reported
Cycle 32 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab10
Values in micrograms per milliliter (μg/ mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab276110Not reportedNot reportedNot reported
Cycle 40 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab5
Values in micrograms per milliliter (μg/ mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab252160Not reportedNot reportedNot reported
Cycle 48 Day 1

Analysis denominator · Participants

GroupSource count
Atezolizumab1
Values in micrograms per milliliter (μg/ mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab555NANot reportedNot reportedNot estimable because there is only 1 participant.
Treatment Discontinuation Visit

Analysis denominator · Participants

GroupSource count
Atezolizumab100
Values in micrograms per milliliter (μg/ mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Atezolizumab12188.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.6
        value
        76.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        256
      units
      Participants
    title
    Cycle 2 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.7
        value
        121
    denoms
    1. counts
      1. group Id
        OG000
        value
        215
      units
      Participants
    title
    Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        90.1
        value
        154
    denoms
    1. counts
      1. group Id
        OG000
        value
        207
      units
      Participants
    title
    Cycle 4 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        98.6
        value
        201
    denoms
    1. counts
      1. group Id
        OG000
        value
        145
      units
      Participants
    title
    Cycle 8 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        102
        value
        213
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      units
      Participants
    title
    Cycle 16 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        128
        value
        245
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Cycle 24 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        110
        value
        276
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Cycle 32 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        160
        value
        252
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Cycle 40 Day 1
  9. categories
    1. measurements
      1. comment
        Not estimable because there is only 1 participant.
        group Id
        OG000
        spread
        NA
        value
        555
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Cycle 48 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        88.8
        value
        121
    denoms
    1. counts
      1. group Id
        OG000
        value
        100
      units
      Participants
    title
    Treatment Discontinuation Visit
denoms
  1. counts
    1. group Id
      OG000
      value
      256
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
    id
    OG000
    title
    Atezolizumab
param Type
MEAN
population Description
PK analyses was based on PK observations from all randomized participants who received atezolizumab and provided at least one PK sample that was evaluable.
reporting Status
POSTED
time Frame
Prior to infusion (0 hour) on Day 1 of Cycles 2, 3, 4, 8, 16, and every eighth cycle thereafter, and at treatment discontinuation until data cut-off on 10 September 2018 (up to approximately 38 months) (cycle duration = 21 days)
title
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
type
SECONDARY
unit Of Measure
micrograms per milliliter (μg/ mL)

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Preserved source evidence · Not medical advice