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NCT03493451 · OUTCOME

Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms · Source last updated 2024-10-26

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
Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)

What was measured

Mean change from baseline at safety follow-up visit in EQ-5D-5L visual analogue score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' An increasing score indicates improvements from baseline.

Analysis population: Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire.

Groups in this outcome

Cohort 1: ENKTL

Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Cohort 2: PTCL-NOS, AITL, and ALCL

Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Cohort 3: MF and SS

Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

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

Analysis denominator · Participants

GroupSource count
Cohort 1: ENKTL22
Cohort 2: PTCL-NOS, AITL, and ALCL44
Cohort 3: MF and SS11

Reported measurements

Cycle 5, Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1: ENKTL12
Cohort 2: PTCL-NOS, AITL, and ALCL19
Cohort 3: MF and SS8
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: ENKTL4.4210.273Not reportedNot reportedNot reported
Cohort 2: PTCL-NOS, AITL, and ALCL1.1113.884Not reportedNot reportedNot reported
Cohort 3: MF and SS0.2522.276Not reportedNot reportedNot reported
Cycle 9, Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1: ENKTL6
Cohort 2: PTCL-NOS, AITL, and ALCL9
Cohort 3: MF and SS6
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: ENKTL1.174.916Not reportedNot reportedNot reported
Cohort 2: PTCL-NOS, AITL, and ALCL5.5621.279Not reportedNot reportedNot reported
Cohort 3: MF and SS-0.8317.713Not reportedNot reportedNot reported
Cycle 13, Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1: ENKTL7
Cohort 2: PTCL-NOS, AITL, and ALCL5
Cohort 3: MF and SS6
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: ENKTL-3.2916.650Not reportedNot reportedNot reported
Cohort 2: PTCL-NOS, AITL, and ALCL15.0019.685Not reportedNot reportedNot reported
Cohort 3: MF and SS1.3321.398Not reportedNot reportedNot reported
Cycle 17, Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1: ENKTL6
Cohort 2: PTCL-NOS, AITL, and ALCL6
Cohort 3: MF and SS6
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: ENKTL0.179.326Not reportedNot reportedNot reported
Cohort 2: PTCL-NOS, AITL, and ALCL10.0017.889Not reportedNot reportedNot reported
Cohort 3: MF and SS3.6723.551Not reportedNot reportedNot reported
Cycle 21, Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1: ENKTL4
Cohort 2: PTCL-NOS, AITL, and ALCL3
Cohort 3: MF and SS4
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: ENKTL4.2510.905Not reportedNot reportedNot reported
Cohort 2: PTCL-NOS, AITL, and ALCL8.3322.546Not reportedNot reportedNot reported
Cohort 3: MF and SS5.5018.285Not reportedNot reportedNot reported
Cycle 25, Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1: ENKTL3
Cohort 2: PTCL-NOS, AITL, and ALCL2
Cohort 3: MF and SS2
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: ENKTL4.0014.422Not reportedNot reportedNot reported
Cohort 2: PTCL-NOS, AITL, and ALCL-2.5010.607Not reportedNot reportedNot reported
Cohort 3: MF and SS5.007.071Not reportedNot reportedNot reported
Cycle 29, Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1: ENKTL3
Cohort 2: PTCL-NOS, AITL, and ALCL2
Cohort 3: MF and SS0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: ENKTL-2.674.619Not reportedNot reportedNot reported
Cohort 2: PTCL-NOS, AITL, and ALCL-5.007.071Not reportedNot reportedNot reported
Cycle 33, Day 1

Analysis denominator · Participants

GroupSource count
Cohort 1: ENKTL1
Cohort 2: PTCL-NOS, AITL, and ALCL1
Cohort 3: MF and SS0
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: ENKTL-3.00NANot reportedNot reportedNot estimable due to sample size
Cohort 2: PTCL-NOS, AITL, and ALCL0.00NANot reportedNot reportedNot estimable due to sample size
Safety Follow-up

Analysis denominator · Participants

GroupSource count
Cohort 1: ENKTL14
Cohort 2: PTCL-NOS, AITL, and ALCL23
Cohort 3: MF and SS2
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: ENKTL-1.508.546Not reportedNot reportedNot reported
Cohort 2: PTCL-NOS, AITL, and ALCL-9.5221.047Not reportedNot reportedNot reported
Cohort 3: MF and SS12.503.536Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.273
        value
        4.42
      2. group Id
        OG001
        spread
        13.884
        value
        1.11
      3. group Id
        OG002
        spread
        22.276
        value
        0.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        8
      units
      Participants
    title
    Cycle 5, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.916
        value
        1.17
      2. group Id
        OG001
        spread
        21.279
        value
        5.56
      3. group Id
        OG002
        spread
        17.713
        value
        -0.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    Cycle 9, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.650
        value
        -3.29
      2. group Id
        OG001
        spread
        19.685
        value
        15.00
      3. group Id
        OG002
        spread
        21.398
        value
        1.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    Cycle 13, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.326
        value
        0.17
      2. group Id
        OG001
        spread
        17.889
        value
        10.00
      3. group Id
        OG002
        spread
        23.551
        value
        3.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    Cycle 17, Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.905
        value
        4.25
      2. group Id
        OG001
        spread
        22.546
        value
        8.33
      3. group Id
        OG002
        spread
        18.285
        value
        5.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        4
      units
      Participants
    title
    Cycle 21, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.422
        value
        4.00
      2. group Id
        OG001
        spread
        10.607
        value
        -2.50
      3. group Id
        OG002
        spread
        7.071
        value
        5.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    Cycle 25, Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.619
        value
        -2.67
      2. group Id
        OG001
        spread
        7.071
        value
        -5.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Cycle 29, Day 1
  8. categories
    1. measurements
      1. comment
        Not estimable due to sample size
        group Id
        OG000
        spread
        NA
        value
        -3.00
      2. comment
        Not estimable due to sample size
        group Id
        OG001
        spread
        NA
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Cycle 33, Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.546
        value
        -1.50
      2. group Id
        OG001
        spread
        21.047
        value
        -9.52
      3. group Id
        OG002
        spread
        3.536
        value
        12.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    Safety Follow-up
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      44
    3. group Id
      OG002
      value
      11
    units
    Participants
description
Mean change from baseline at safety follow-up visit in EQ-5D-5L visual analogue score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' An increasing score indicates improvements from baseline.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    id
    OG000
    title
    Cohort 1: ENKTL
  2. description
    Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    id
    OG001
    title
    Cohort 2: PTCL-NOS, AITL, and ALCL
  3. description
    Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    id
    OG002
    title
    Cohort 3: MF and SS
param Type
MEAN
population Description
Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire.
reporting Status
POSTED
time Frame
Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week)
title
Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score
type
SECONDARY
unit Of Measure
Score on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice