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NCT01712490 · OUTCOME

A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)

A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma · Source last updated 2026-02-27

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

Measure
GEOMETRIC_MEAN
Unit
nanogram per milliliter (ng/mL)
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose

Analysis population: The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.

Groups in this outcome

A+AVD

Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m\^2), vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.

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

Analysis denominator · Participants

GroupSource count
A+AVD59

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
A+AVD59
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
A+AVD3.202.99Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
A+AVD56
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
A+AVD1.360.790Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.99
        value
        3.20
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.790
        value
        1.36
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      units
      Participants
    title
    Cycle 3 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      59
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m\^2), vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
    id
    OG000
    title
    A+AVD
param Type
GEOMETRIC_MEAN
population Description
The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
title
A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
type
SECONDARY
unit Of Measure
nanogram per milliliter (ng/mL)

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

Preserved source evidence · Not medical advice