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NCT02541604 · OUTCOME

Maximum Serum Concentration (Cmax) 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
Predose (PRD; 0 hours [hr]), 0.5 hr post-infusion (P-I; infusion duration=30-60 minutes) on Day (D) 1 of Cycle (Cy) 1 and 4 (1 Cy=21 days)

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)2
2 to <12 Age (Years)26
12 to <18 Age (Years)34
>=18 Age (Years)18

Reported measurements

Cycle 1

Analysis denominator · Participants

GroupSource count
<2 Age (Years)2
2 to <12 Age (Years)26
12 to <18 Age (Years)34
>=18 Age (Years)18
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
<2 Age (Years)1056.90Not reportedNot reportedNot reported
2 to <12 Age (Years)31228.7Not reportedNot reportedNot reported
12 to <18 Age (Years)33726.8Not reportedNot reportedNot reported
>=18 Age (Years)42426.9Not 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)38216.4Not reportedNot reportedNot reported
12 to <18 Age (Years)37378.9Not reportedNot reportedNot reported
>=18 Age (Years)62629.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.90
        value
        105
      2. group Id
        OG001
        spread
        28.7
        value
        312
      3. group Id
        OG002
        spread
        26.8
        value
        337
      4. group Id
        OG003
        spread
        26.9
        value
        424
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        26
      3. group Id
        OG002
        value
        34
      4. group Id
        OG003
        value
        18
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG001
        spread
        16.4
        value
        382
      2. group Id
        OG002
        spread
        78.9
        value
        373
      3. group Id
        OG003
        spread
        29.2
        value
        626
    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
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      26
    3. group Id
      OG002
      value
      34
    4. group Id
      OG003
      value
      18
    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
Predose (PRD; 0 hours [hr]), 0.5 hr post-infusion (P-I; infusion duration=30-60 minutes) on Day (D) 1 of Cycle (Cy) 1 and 4 (1 Cy=21 days)
title
Maximum Serum Concentration (Cmax) of Atezolizumab
type
PRIMARY
unit Of Measure
ug/mL

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Preserved source evidence · Not medical advice