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NCT03438396 · OUTCOME

Plasma Concentrations of Tisotumab Vedotin (HuMax-TF), Tisotumab Vedotin Antibody-drug Conjugate (HuMax-TF-ADC), and Free Monomethyl Auristatin E (MMAE)

A Trial of Tisotumab Vedotin in Cervical Cancer · Source last updated 2023-07-25

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
Geometric Coefficient of Variation
Time frame
Predose and end of infusion of Cycle 1 Day 1 (C1D1) and Cycle 6 Day 1 (C6D1)

What was measured

Plasma concentrations of HuMax-TF, HuMax-TF-ADC, and Free MMAE measures on Cycle 1 Day 1 (predose and end of infusion) and Cycle 6 Day 1 (predose and end of infusion) are reported.

Analysis population: FAS included all participants who received at least 1 dose of tisotumab vedotin.

Groups in this outcome

Tisotumab Vedotin

Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin101

Reported measurements

HuMax-TF (C1D1-predose)

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin98
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin163.4860.70Not reportedNot reportedNot reported
HuMax-TF (C1D1-end of infusion)

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin98
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin41691.068.02Not reportedNot reportedNot reported
HuMax-TF (C6D1-predose)

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin54
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin150.00.0Not reportedNot reportedNot reported
HuMax-TF (C6D1-end of infusion)

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin54
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin3694125.88Not reportedNot reportedNot reported
HuMax-TF-ADC (C1D1-predose)

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin97
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin30.00.0Not reportedNot reportedNot reported
HuMax-TF-ADC (C1D1-end of infusion)

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin97
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin3810592.62Not reportedNot reportedNot reported
HuMax-TF-ADC (C6D1-predose)

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin54
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin30.00.0Not reportedNot reportedNot reported
HuMax-TF-ADC (C6D1-end of infusion)

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin53
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin36270.028.29Not reportedNot reportedNot reported
MMAE (C1D1-predose)

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin96
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin12.500.0Not reportedNot reportedNot reported
MMAE (C1D1-end of infusion)

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin97
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin171.27102.05Not reportedNot reportedNot reported
MMAE (C6D1-predose)

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin53
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin46.71146.11Not reportedNot reportedNot reported
MMAE (C6D1-end of infusion)

Analysis denominator · Participants

GroupSource count
Tisotumab Vedotin54
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Tisotumab Vedotin177.4682.62Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.70
        value
        163.48
    denoms
    1. counts
      1. group Id
        OG000
        value
        98
      units
      Participants
    title
    HuMax-TF (C1D1-predose)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        68.02
        value
        41691.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        98
      units
      Participants
    title
    HuMax-TF (C1D1-end of infusion)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0
        value
        150.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      units
      Participants
    title
    HuMax-TF (C6D1-predose)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.88
        value
        36941
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      units
      Participants
    title
    HuMax-TF (C6D1-end of infusion)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0
        value
        30.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        97
      units
      Participants
    title
    HuMax-TF-ADC (C1D1-predose)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        92.62
        value
        38105
    denoms
    1. counts
      1. group Id
        OG000
        value
        97
      units
      Participants
    title
    HuMax-TF-ADC (C1D1-end of infusion)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0
        value
        30.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      units
      Participants
    title
    HuMax-TF-ADC (C6D1-predose)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.29
        value
        36270.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      units
      Participants
    title
    HuMax-TF-ADC (C6D1-end of infusion)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0
        value
        12.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      units
      Participants
    title
    MMAE (C1D1-predose)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        102.05
        value
        171.27
    denoms
    1. counts
      1. group Id
        OG000
        value
        97
      units
      Participants
    title
    MMAE (C1D1-end of infusion)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        146.11
        value
        46.71
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      units
      Participants
    title
    MMAE (C6D1-predose)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        82.62
        value
        177.46
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      units
      Participants
    title
    MMAE (C6D1-end of infusion)
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    units
    Participants
description
Plasma concentrations of HuMax-TF, HuMax-TF-ADC, and Free MMAE measures on Cycle 1 Day 1 (predose and end of infusion) and Cycle 6 Day 1 (predose and end of infusion) are reported.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received IV tisotumab vedotin 2.0 mg/kg Q3W until radiographic disease progression verified by the IRC, unacceptable AEs requiring drug discontinuation, withdrawal of consent, lost to follow up or death, whichever occurred first.
    id
    OG000
    title
    Tisotumab Vedotin
param Type
GEOMETRIC_MEAN
population Description
FAS included all participants who received at least 1 dose of tisotumab vedotin.
reporting Status
POSTED
time Frame
Predose and end of infusion of Cycle 1 Day 1 (C1D1) and Cycle 6 Day 1 (C6D1)
title
Plasma Concentrations of Tisotumab Vedotin (HuMax-TF), Tisotumab Vedotin Antibody-drug Conjugate (HuMax-TF-ADC), and Free Monomethyl Auristatin E (MMAE)
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice