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NCT01578499 · OUTCOME

Cmax: Maximum Observed Concentration for Monomethyl Auristatin (MMAE) for Brentuximab Vedotin

A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study) · Source last updated 2021-01-05

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Day 1 pre-dose and 30 minutes after infusion ended in Cycles 1 and 3

Analysis population: The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.

Groups in this outcome

pcALCL: Brentuximab Vedotin

Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).

MF: Brentuximab Vedotin 1.8 mg/kg

Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).

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

Analysis denominator · Participants

GroupSource count
pcALCL: Brentuximab Vedotin16
MF: Brentuximab Vedotin 1.8 mg/kg50

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
pcALCL: Brentuximab Vedotin13
MF: Brentuximab Vedotin 1.8 mg/kg46
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin2.531.382Not reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg3.341.901Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
pcALCL: Brentuximab Vedotin12
MF: Brentuximab Vedotin 1.8 mg/kg36
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin2.961.176Not reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg3.081.276Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.382
        value
        2.53
      2. group Id
        OG001
        spread
        1.901
        value
        3.34
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        46
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.176
        value
        2.96
      2. group Id
        OG001
        spread
        1.276
        value
        3.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    Cycle 3 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      50
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
    id
    OG000
    title
    pcALCL: Brentuximab Vedotin
  2. description
    Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
    id
    OG001
    title
    MF: Brentuximab Vedotin 1.8 mg/kg
param Type
MEAN
population Description
The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.
reporting Status
POSTED
time Frame
Day 1 pre-dose and 30 minutes after infusion ended in Cycles 1 and 3
title
Cmax: Maximum Observed Concentration for Monomethyl Auristatin (MMAE) for Brentuximab Vedotin
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice