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NCT01578499 · OUTCOME

Cmax: Maximum Observed Concentration 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
ug/mL
Interval / dispersion
Standard Deviation
Time frame
Day 1 pre-dose and 30 minutes after infusion in Cycles 1 and 3

Analysis population: The pharmacokinetic (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 primary cutaneous anaplastic large cell lymphoma (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 mycosis fungoides (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 Vedotin15
MF: Brentuximab Vedotin 1.8 mg/kg50
Values in ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin38.369.427Not reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg38.408.912Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
pcALCL: Brentuximab Vedotin12
MF: Brentuximab Vedotin 1.8 mg/kg41
Values in ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin40.1412.697Not reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg36.6914.249Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.427
        value
        38.36
      2. group Id
        OG001
        spread
        8.912
        value
        38.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        50
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.697
        value
        40.14
      2. group Id
        OG001
        spread
        14.249
        value
        36.69
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        41
      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 primary cutaneous anaplastic large cell lymphoma (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 mycosis fungoides (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 pharmacokinetic (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 in Cycles 1 and 3
title
Cmax: Maximum Observed Concentration for Brentuximab Vedotin
type
SECONDARY
unit Of Measure
ug/mL

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

Preserved source evidence · Not medical advice