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NCT02541604 · OUTCOME

Minimum Serum Concentration (Cmin) of Atezolizumab

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Pediatric and Young Adult Participants With Solid Tumors · Source last updated 2020-02-25

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

Measure
GEOMETRIC_MEAN
Unit
ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
PRD (0 hr) on D1 of Cy2,3,4,8, 12, 16 (1 Cy=21 days) and every 8 cycles thereafter; at any time during visit at study drug discontinuation visit, at least 90 days (maximum 150 days) after the last dose of study drug (up to approximately 42 months)

Analysis population: Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff. In the "\<2 Age (Years)" Arm/Group, 1 participant died after study entry with 1 cycle, and the other participant died after two cycles.

Groups in this outcome

<2 Age (Years)

Participants \<2 Age (Years)

2 to <12 Age (Years)

Participants 2 to \<12 Age (Years)

12 to <18 Age (Years)

Participants 12 to \<18 Age (Years)

>=18 Age (Years)

Participants \>=18 Age (Years)

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

Analysis denominator · Participants

GroupSource count
<2 Age (Years)1
2 to <12 Age (Years)25
12 to <18 Age (Years)32
>=18 Age (Years)16

Reported measurements

Cycle 2

Analysis denominator · Participants

GroupSource count
<2 Age (Years)1
2 to <12 Age (Years)25
12 to <18 Age (Years)32
>=18 Age (Years)16
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
<2 Age (Years)24.1NANot reportedNot reportedLater cycles are NA because 1 participant died after study entry with 1 cycle, and the other participant died after two cycles.
2 to <12 Age (Years)59.331.4Not reportedNot reportedNot reported
12 to <18 Age (Years)56.550.4Not reportedNot reportedNot reported
>=18 Age (Years)79.952.7Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
<2 Age (Years)0
2 to <12 Age (Years)13
12 to <18 Age (Years)19
>=18 Age (Years)8
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
2 to <12 Age (Years)58.9234.4Not reportedNot reportedNot reported
12 to <18 Age (Years)85.047.4Not reportedNot reportedNot reported
>=18 Age (Years)14848.9Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
<2 Age (Years)0
2 to <12 Age (Years)11
12 to <18 Age (Years)16
>=18 Age (Years)6
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
2 to <12 Age (Years)99.236.4Not reportedNot reportedNot reported
12 to <18 Age (Years)11341.1Not reportedNot reportedNot reported
>=18 Age (Years)12180.4Not reportedNot reportedNot reported
Cycle 8

Analysis denominator · Participants

GroupSource count
<2 Age (Years)0
2 to <12 Age (Years)4
12 to <18 Age (Years)4
>=18 Age (Years)2
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
2 to <12 Age (Years)16619.8Not reportedNot reportedNot reported
12 to <18 Age (Years)14521.9Not reportedNot reportedNot reported
>=18 Age (Years)2098.10Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Later cycles are NA because 1 participant died after study entry with 1 cycle, and the other participant died after two cycles.
        group Id
        OG000
        spread
        NA
        value
        24.1
      2. group Id
        OG001
        spread
        31.4
        value
        59.3
      3. group Id
        OG002
        spread
        50.4
        value
        56.5
      4. group Id
        OG003
        spread
        52.7
        value
        79.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        32
      4. group Id
        OG003
        value
        16
      units
      Participants
    title
    Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG001
        spread
        234.4
        value
        58.9
      2. group Id
        OG002
        spread
        47.4
        value
        85.0
      3. group Id
        OG003
        spread
        48.9
        value
        148
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        19
      4. group Id
        OG003
        value
        8
      units
      Participants
    title
    Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG001
        spread
        36.4
        value
        99.2
      2. group Id
        OG002
        spread
        41.1
        value
        113
      3. group Id
        OG003
        spread
        80.4
        value
        121
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        16
      4. group Id
        OG003
        value
        6
      units
      Participants
    title
    Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG001
        spread
        19.8
        value
        166
      2. group Id
        OG002
        spread
        21.9
        value
        145
      3. group Id
        OG003
        spread
        8.10
        value
        209
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        2
      units
      Participants
    title
    Cycle 8
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      25
    3. group Id
      OG002
      value
      32
    4. group Id
      OG003
      value
      16
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants \<2 Age (Years)
    id
    OG000
    title
    <2 Age (Years)
  2. description
    Participants 2 to \<12 Age (Years)
    id
    OG001
    title
    2 to <12 Age (Years)
  3. description
    Participants 12 to \<18 Age (Years)
    id
    OG002
    title
    12 to <18 Age (Years)
  4. description
    Participants \>=18 Age (Years)
    id
    OG003
    title
    >=18 Age (Years)
param Type
GEOMETRIC_MEAN
population Description
Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff. In the "\<2 Age (Years)" Arm/Group, 1 participant died after study entry with 1 cycle, and the other participant died after two cycles.
reporting Status
POSTED
time Frame
PRD (0 hr) on D1 of Cy2,3,4,8, 12, 16 (1 Cy=21 days) and every 8 cycles thereafter; at any time during visit at study drug discontinuation visit, at least 90 days (maximum 150 days) after the last dose of study drug (up to approximately 42 months)
title
Minimum Serum Concentration (Cmin) of Atezolizumab
type
PRIMARY
unit Of Measure
ug/mL

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Preserved source evidence · Not medical advice