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NCT02713529 · OUTCOME

AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Last (AUClast) During Treatment Cycles 1 + 2

Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer · Source last updated 2023-01-20

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

Measure
GEOMETRIC_MEAN
Unit
hr*ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36

What was measured

AUClast is the area under the serum concentration-time curve from time zero to time of last quantifiable concentration.

Analysis population: Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.

Groups in this outcome

AMG 820 1100 mg

Includes participants from all treatment arms that were administered AMG 820 1100 mg.

AMG 820 1400 mg

Includes participants from all treatment arms who were administered AMG 820 1400 mg

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

Analysis denominator · Participants

GroupSource count
AMG 820 1100 mg97
AMG 820 1400 mg18

Reported measurements

Cycle 1

Analysis denominator · Participants

GroupSource count
AMG 820 1100 mg97
AMG 820 1400 mg18
Values in hr*ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
AMG 820 1100 mg5510037Not reportedNot reportedNot reported
AMG 820 1400 mg8040033Not reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
AMG 820 1100 mg71
AMG 820 1400 mg10
Values in hr*ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
AMG 820 1100 mg5520038Not reportedNot reportedNot reported
AMG 820 1400 mg7350045Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        37
        value
        55100
      2. group Id
        OG001
        spread
        33
        value
        80400
    denoms
    1. counts
      1. group Id
        OG000
        value
        97
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        38
        value
        55200
      2. group Id
        OG001
        spread
        45
        value
        73500
    denoms
    1. counts
      1. group Id
        OG000
        value
        71
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Cycle 2
denoms
  1. counts
    1. group Id
      OG000
      value
      97
    2. group Id
      OG001
      value
      18
    units
    Participants
description
AUClast is the area under the serum concentration-time curve from time zero to time of last quantifiable concentration.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Includes participants from all treatment arms that were administered AMG 820 1100 mg.
    id
    OG000
    title
    AMG 820 1100 mg
  2. description
    Includes participants from all treatment arms who were administered AMG 820 1400 mg
    id
    OG001
    title
    AMG 820 1400 mg
param Type
GEOMETRIC_MEAN
population Description
Pharmacovigilence Analysis Set contains all participants who received at least 1 dose of AMG 820 and have at least one PK sample collected.
reporting Status
POSTED
time Frame
Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36
title
AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Last (AUClast) During Treatment Cycles 1 + 2
type
SECONDARY
unit Of Measure
hr*ug/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice