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NCT01578499 · OUTCOME

Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) 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 EOT and during posttreatment (LTFU) - (Median follow-up 38.8 months)

What was measured

FACT-G is a 27-item general cancer QOL instrument completed by participants receiving cancer treatment. FACT-G incorporates a 7-day recall period and contains 4 primary subscales: Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28); Fact-G total score=sum of PWB, SWB, EWB, FWB, point range 0-108. Higher scores for the total scales and subscales indicate better quality of life. 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 Vedotin56
Methotrexate or Bexarotene46
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin1.4310.168Not reportedNot reportedNot reported
Methotrexate or Bexarotene-0.3711.723Not reportedNot reportedNot reported
Change at Cycle 4

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin50
Methotrexate or Bexarotene32
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin1.7512.014Not reportedNot reportedNot reported
Methotrexate or Bexarotene1.7810.740Not 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 Vedotin4.2314.257Not reportedNot reportedNot reported
Methotrexate or Bexarotene2.2413.108Not reportedNot reportedNot reported
Change at Cycle 8

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin37
Methotrexate or Bexarotene13
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin5.9616.030Not reportedNot reportedNot reported
Methotrexate or Bexarotene2.5410.809Not 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 Vedotin6.6116.971Not reportedNot reportedNot reported
Methotrexate or Bexarotene4.3815.040Not reportedNot reportedNot reported
Change at Cycle 12

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin27
Methotrexate or Bexarotene8
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin7.9418.837Not reportedNot reportedNot reported
Methotrexate or Bexarotene8.6121.024Not reportedNot reportedNot reported
Change at Cycle 14

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin26
Methotrexate or Bexarotene6
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin9.0414.104Not reportedNot reportedNot reported
Methotrexate or Bexarotene10.7513.615Not reportedNot reportedNot reported
Change at Cycle 16

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin22
Methotrexate or Bexarotene4
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin5.089.230Not reportedNot reportedNot reported
Methotrexate or Bexarotene7.8823.432Not 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 Vedotin0.3516.067Not reportedNot reportedNot reported
Methotrexate or Bexarotene-2.2917.171Not reportedNot reportedNot reported
Change at 3-6 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin2
Methotrexate or Bexarotene2
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin16.0018.385Not reportedNot reportedNot reported
Methotrexate or Bexarotene-2.928.367Not reportedNot reportedNot reported
Change at 6-9 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin6
Methotrexate or Bexarotene12
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-0.1919.648Not reportedNot reportedNot reported
Methotrexate or Bexarotene-2.5912.473Not 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 Vedotin3.6217.651Not reportedNot reportedNot reported
Methotrexate or Bexarotene-5.3210.555Not reportedNot reportedNot reported
Change at 12-15 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin26
Methotrexate or Bexarotene19
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin8.3314.918Not reportedNot reportedNot reported
Methotrexate or Bexarotene-1.3411.905Not reportedNot reportedNot reported
Change at 15-18 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin24
Methotrexate or Bexarotene18
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin3.0312.618Not reportedNot reportedNot reported
Methotrexate or Bexarotene2.9414.756Not reportedNot reportedNot reported
Change at 18-21 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin24
Methotrexate or Bexarotene16
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin3.3511.117Not reportedNot reportedNot reported
Methotrexate or Bexarotene-0.1914.316Not reportedNot reportedNot reported
Change at 21-24 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin17
Methotrexate or Bexarotene18
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin1.515.471Not reportedNot reportedNot reported
Methotrexate or Bexarotene0.6114.505Not reportedNot reportedNot reported
Change at 24-27 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin20
Methotrexate or Bexarotene15
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin4.207.952Not reportedNot reportedNot reported
Methotrexate or Bexarotene1.4217.870Not reportedNot reportedNot reported
Change at 27-30 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin19
Methotrexate or Bexarotene17
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-1.5717.488Not reportedNot reportedNot reported
Methotrexate or Bexarotene1.938.716Not reportedNot reportedNot reported
Change at >30 months LTFU

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin22
Methotrexate or Bexarotene19
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin-6.2215.222Not reportedNot reportedNot reported
Methotrexate or Bexarotene-2.855.518Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.168
        value
        1.43
      2. group Id
        OG001
        spread
        11.723
        value
        -0.37
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        46
      units
      Participants
    title
    Change at Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.014
        value
        1.75
      2. group Id
        OG001
        spread
        10.740
        value
        1.78
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        32
      units
      Participants
    title
    Change at Cycle 4
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.257
        value
        4.23
      2. group Id
        OG001
        spread
        13.108
        value
        2.24
    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
        16.030
        value
        5.96
      2. group Id
        OG001
        spread
        10.809
        value
        2.54
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    Change at Cycle 8
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.971
        value
        6.61
      2. group Id
        OG001
        spread
        15.040
        value
        4.38
    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
        18.837
        value
        7.94
      2. group Id
        OG001
        spread
        21.024
        value
        8.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Change at Cycle 12
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.104
        value
        9.04
      2. group Id
        OG001
        spread
        13.615
        value
        10.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Change at Cycle 14
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.230
        value
        5.08
      2. group Id
        OG001
        spread
        23.432
        value
        7.88
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Change at Cycle 16
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.067
        value
        0.35
      2. group Id
        OG001
        spread
        17.171
        value
        -2.29
    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
        18.385
        value
        16.00
      2. group Id
        OG001
        spread
        8.367
        value
        -2.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Change at 3-6 months LTFU
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.648
        value
        -0.19
      2. group Id
        OG001
        spread
        12.473
        value
        -2.59
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Change at 6-9 months LTFU
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.651
        value
        3.62
      2. group Id
        OG001
        spread
        10.555
        value
        -5.32
    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
FACT-G is a 27-item general cancer QOL instrument completed by participants receiving cancer treatment. FACT-G incorporates a 7-day recall period and contains 4 primary subscales: Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28); Fact-G total score=sum of PWB, SWB, EWB, FWB, point range 0-108. Higher scores for the total scales and subscales indicate better quality of life. 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 EOT and during posttreatment (LTFU) - (Median follow-up 38.8 months)
title
Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) Score
type
SECONDARY
unit Of Measure
score on a scale

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Preserved source evidence · Not medical advice