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NCT01578499 · OUTCOME

Change From Baseline in the Skindex-29 Questionnaire Total Score

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
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at End of Treatment (EOT) and during posttreatment long treatment follow-up (LTFU) - (Median follow-up 38.8 months)

What was measured

Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.

Analysis population: The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.

Groups in this outcome

Brentuximab Vedotin

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).

Methotrexate or Bexarotene

Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 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
Brentuximab Vedotin64
Methotrexate or Bexarotene64

Reported measurements

Change at Cycle 2

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin55
Methotrexate or Bexarotene45
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-5.4411.055Not reportedNot reportedNot reported
Methotrexate or Bexarotene-2.4911.959Not reportedNot reportedNot reported
Change at Cycle 4

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin49
Methotrexate or Bexarotene30
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-14.6017.488Not reportedNot reportedNot reported
Methotrexate or Bexarotene-6.719.755Not reportedNot reportedNot reported
Change at Cycle 6

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin40
Methotrexate or Bexarotene25
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-17.5917.770Not reportedNot reportedNot reported
Methotrexate or Bexarotene-5.409.758Not reportedNot reportedNot reported
Change at Cycle 8

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin37
Methotrexate or Bexarotene14
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-21.7318.882Not reportedNot reportedNot reported
Methotrexate or Bexarotene-7.2816.769Not reportedNot reportedNot reported
Change at Cycle 10

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin35
Methotrexate or Bexarotene13
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-22.4721.722Not reportedNot reportedNot reported
Methotrexate or Bexarotene-3.7121.752Not reportedNot reportedNot reported
Change at Cycle 12

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin25
Methotrexate or Bexarotene8
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-23.3721.555Not reportedNot reportedNot reported
Methotrexate or Bexarotene-5.2217.704Not reportedNot reportedNot reported
Change at Cycle 14

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin25
Methotrexate or Bexarotene5
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-19.7220.980Not reportedNot reportedNot reported
Methotrexate or Bexarotene-7.4922.463Not reportedNot reportedNot reported
Change at Cycle 16

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin22
Methotrexate or Bexarotene3
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-19.3518.911Not reportedNot reportedNot reported
Methotrexate or Bexarotene0.7510.308Not reportedNot reportedNot reported
Change at End of Treatment

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin47
Methotrexate or Bexarotene37
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-16.2623.281Not reportedNot reportedNot reported
Methotrexate or Bexarotene-0.9618.973Not reportedNot reportedNot reported
Change at 3-6 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin2
Methotrexate or Bexarotene3
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-1.073.704Not reportedNot reportedNot reported
Methotrexate or Bexarotene-9.4821.629Not reportedNot reportedNot reported
Change at 6-9 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin6
Methotrexate or Bexarotene11
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-8.048.800Not reportedNot reportedNot reported
Methotrexate or Bexarotene-9.6817.789Not reportedNot reportedNot reported
Change at 9-12 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin7
Methotrexate or Bexarotene10
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-7.9415.582Not reportedNot reportedNot reported
Methotrexate or Bexarotene-4.9314.516Not reportedNot reportedNot reported
Change at 12-15 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin25
Methotrexate or Bexarotene21
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-16.2118.438Not reportedNot reportedNot reported
Methotrexate or Bexarotene-11.1618.183Not reportedNot reportedNot reported
Change at 15-18 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin25
Methotrexate or Bexarotene18
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-19.1819.475Not reportedNot reportedNot reported
Methotrexate or Bexarotene-8.5312.768Not reportedNot reportedNot reported
Change at 18-21 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin22
Methotrexate or Bexarotene17
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-19.2720.962Not reportedNot reportedNot reported
Methotrexate or Bexarotene-5.4616.679Not reportedNot reportedNot reported
Change at 21-24 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin18
Methotrexate or Bexarotene19
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-16.6019.875Not reportedNot reportedNot reported
Methotrexate or Bexarotene-6.8614.991Not reportedNot reportedNot reported
Change at 24-27 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin21
Methotrexate or Bexarotene16
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-17.0415.982Not reportedNot reportedNot reported
Methotrexate or Bexarotene-9.0523.990Not reportedNot reportedNot reported
Change at 27-30 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin20
Methotrexate or Bexarotene18
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-12.4519.639Not reportedNot reportedNot reported
Methotrexate or Bexarotene-7.9716.401Not reportedNot reportedNot reported
Change at >30 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin23
Methotrexate or Bexarotene20
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-11.4922.470Not reportedNot reportedNot reported
Methotrexate or Bexarotene-1.0718.886Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.055
        value
        -5.44
      2. group Id
        OG001
        spread
        11.959
        value
        -2.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        55
      2. group Id
        OG001
        value
        45
      units
      Participants
    title
    Change at Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.488
        value
        -14.60
      2. group Id
        OG001
        spread
        9.755
        value
        -6.71
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        30
      units
      Participants
    title
    Change at Cycle 4
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.770
        value
        -17.59
      2. group Id
        OG001
        spread
        9.758
        value
        -5.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        25
      units
      Participants
    title
    Change at Cycle 6
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.882
        value
        -21.73
      2. group Id
        OG001
        spread
        16.769
        value
        -7.28
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    Change at Cycle 8
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.722
        value
        -22.47
      2. group Id
        OG001
        spread
        21.752
        value
        -3.71
    denoms
    1. counts
      1. group Id
        OG000
        value
        35
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    Change at Cycle 10
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.555
        value
        -23.37
      2. group Id
        OG001
        spread
        17.704
        value
        -5.22
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Change at Cycle 12
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.980
        value
        -19.72
      2. group Id
        OG001
        spread
        22.463
        value
        -7.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Change at Cycle 14
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.911
        value
        -19.35
      2. group Id
        OG001
        spread
        10.308
        value
        0.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Change at Cycle 16
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.281
        value
        -16.26
      2. group Id
        OG001
        spread
        18.973
        value
        -0.96
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    Change at End of Treatment
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.704
        value
        -1.07
      2. group Id
        OG001
        spread
        21.629
        value
        -9.48
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Change at 3-6 months LTFU
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.800
        value
        -8.04
      2. group Id
        OG001
        spread
        17.789
        value
        -9.68
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Change at 6-9 months LTFU
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.582
        value
        -7.94
      2. group Id
        OG001
        spread
        14.516
        value
        -4.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Change at 9-12 months LTFU
denoms
  1. counts
    1. group Id
      OG000
      value
      64
    2. group Id
      OG001
      value
      64
    units
    Participants
description
Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.
dispersion Type
Standard Deviation
groups
  1. description
    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
    Brentuximab Vedotin
  2. description
    Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
    id
    OG001
    title
    Methotrexate or Bexarotene
param Type
MEAN
population Description
The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.
reporting Status
POSTED
time Frame
Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at End of Treatment (EOT) and during posttreatment long treatment follow-up (LTFU) - (Median follow-up 38.8 months)
title
Change From Baseline in the Skindex-29 Questionnaire Total Score
type
SECONDARY
unit Of Measure
score on a scale

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Preserved source evidence · Not medical advice