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NCT02541604 · OUTCOME

Area Under the Concentration-Time Curve (AUC) 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
ugxday/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
PRD (0 hr), 0.5 hr P-I (infusion duration=30-60 minutes) on D1 of Cy1; at any time during visit on Cy1D8 (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.

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)29
12 to <18 Age (Years)38
>=18 Age (Years)18

Reported measurements

Source class 1
Values in ugxday/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
<2 Age (Years)11305.28Not reportedNot reportedNot reported
2 to <12 Age (Years)220921.3Not reportedNot reportedNot reported
12 to <18 Age (Years)281617.7Not reportedNot reportedNot reported
>=18 Age (Years)357928.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.28
        value
        1130
      2. group Id
        OG001
        spread
        21.3
        value
        2209
      3. group Id
        OG002
        spread
        17.7
        value
        2816
      4. group Id
        OG003
        spread
        28.4
        value
        3579
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      29
    3. group Id
      OG002
      value
      38
    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.
reporting Status
POSTED
time Frame
PRD (0 hr), 0.5 hr P-I (infusion duration=30-60 minutes) on D1 of Cy1; at any time during visit on Cy1D8 (1 Cy=21 days)
title
Area Under the Concentration-Time Curve (AUC) of Atezolizumab
type
PRIMARY
unit Of Measure
ugxday/mL

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

Preserved source evidence · Not medical advice