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NCT01950364 · OUTCOME

Serum Concentrations of Antibody-drug Conjugate (ADC)

A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma · Source last updated 2016-05-11

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose

What was measured

The LLQ for all the observations was 12.5 ng/mL.

Analysis population: PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.

Groups in this outcome

Brentuximab Vedotin

Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.

Brentuximab Vedotin + Rifampicin

Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.

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

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin9
Brentuximab Vedotin + Rifampicin9

Reported measurements

Cycle 1, Predose
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab VedotinNANANot reportedNot reportedNone of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
Brentuximab Vedotin + RifampicinNANANot reportedNot reportedNone of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
Cycle 1, 0.5 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin29609.775911865.35702Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin33125.002510398.79403Not reportedNot reportedNot reported
Cycle 1, 4 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin24398.64828092.41448Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin24533.23726767.70744Not reportedNot reportedNot reported
Cycle 1, 72 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin4265.75422880.39660Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin5958.05691788.56378Not reportedNot reportedNot reported
Cycle 1, 336 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin1167.0713740.05650Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin1108.6515376.81123Not reportedNot reportedNot reported
Cycle 2, Predose
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin794.385110732.46886Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin435.1550303.25245Not reportedNot reportedNot reported
Cycle 2, 0.5 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin16032.649415714.59821Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin31627.25666716.71906Not reportedNot reportedNot reported
Cycle 3, Predose
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin611.0573786.52082Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin536.3692524.72923Not reportedNot reportedNot reported
Cycle 3, 0.5 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin20991.961812662.05087Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin33040.22456295.45517Not reportedNot reportedNot reported
Cycle 3, 4 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin15378.82749550.99903Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin24496.72034212.84997Not reportedNot reportedNot reported
Cycle 3, 72 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin3258.72373358.78504Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin4262.03642431.24647Not reportedNot reportedNot reported
Cycle 3, 336 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin1381.22901224.66857Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin1363.9488789.04877Not reportedNot reportedNot reported
Cycle 3, 480 hour
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin648.24921065.26404Not reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin734.5557634.23889Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
        group Id
        OG001
        spread
        NA
        value
        NA
    title
    Cycle 1, Predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        11865.35702
        value
        29609.7759
      2. group Id
        OG001
        spread
        10398.79403
        value
        33125.0025
    title
    Cycle 1, 0.5 hour
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        8092.41448
        value
        24398.6482
      2. group Id
        OG001
        spread
        6767.70744
        value
        24533.2372
    title
    Cycle 1, 4 hour
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        2880.39660
        value
        4265.7542
      2. group Id
        OG001
        spread
        1788.56378
        value
        5958.0569
    title
    Cycle 1, 72 hour
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        740.05650
        value
        1167.0713
      2. group Id
        OG001
        spread
        376.81123
        value
        1108.6515
    title
    Cycle 1, 336 hour
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        10732.46886
        value
        794.3851
      2. group Id
        OG001
        spread
        303.25245
        value
        435.1550
    title
    Cycle 2, Predose
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        15714.59821
        value
        16032.6494
      2. group Id
        OG001
        spread
        6716.71906
        value
        31627.2566
    title
    Cycle 2, 0.5 hour
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        786.52082
        value
        611.0573
      2. group Id
        OG001
        spread
        524.72923
        value
        536.3692
    title
    Cycle 3, Predose
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        12662.05087
        value
        20991.9618
      2. group Id
        OG001
        spread
        6295.45517
        value
        33040.2245
    title
    Cycle 3, 0.5 hour
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        9550.99903
        value
        15378.8274
      2. group Id
        OG001
        spread
        4212.84997
        value
        24496.7203
    title
    Cycle 3, 4 hour
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        3358.78504
        value
        3258.7237
      2. group Id
        OG001
        spread
        2431.24647
        value
        4262.0364
    title
    Cycle 3, 72 hour
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        1224.66857
        value
        1381.2290
      2. group Id
        OG001
        spread
        789.04877
        value
        1363.9488
    title
    Cycle 3, 336 hour
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      9
    units
    Participants
description
The LLQ for all the observations was 12.5 ng/mL.
dispersion Type
Standard Deviation
groups
  1. description
    Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
    id
    OG000
    title
    Brentuximab Vedotin
  2. description
    Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
    id
    OG001
    title
    Brentuximab Vedotin + Rifampicin
param Type
GEOMETRIC_MEAN
population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
reporting Status
POSTED
time Frame
Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose
title
Serum Concentrations of Antibody-drug Conjugate (ADC)
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice