Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03391466 · OUTCOME

Change From Baseline in EQ-5D-5L VAS Scale Score

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma · Source last updated 2025-12-01

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

Measure
MEAN
Unit
Score on scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24

What was measured

The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). The value 100 indicates improvement.

Analysis population: Participants in QoL analysis set with data available at given timepoint were analyzed.

Groups in this outcome

Axicabtagene Ciloleucel

Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

Standard of Care Therapy

Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.

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

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel165
Standard of Care Therapy129

Reported measurements

Score at Baseline

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel165
Standard of Care Therapy129
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel72.418.7Not reportedNot reportedNot reported
Standard of Care Therapy74.420.1Not reportedNot reportedNot reported
Change from Baseline at Study Day 50

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel163
Standard of Care Therapy124
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel-1.918.7Not reportedNot reportedNot reported
Standard of Care Therapy-4.416.7Not reportedNot reportedNot reported
Change from Baseline at Study Day 100

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel145
Standard of Care Therapy64
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel4.018.4Not reportedNot reportedNot reported
Standard of Care Therapy-8.219.8Not reportedNot reportedNot reported
Change from Baseline at Study Day 150

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel110
Standard of Care Therapy54
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel9.119.4Not reportedNot reportedNot reported
Standard of Care Therapy-2.222.2Not reportedNot reportedNot reported
Change from Baseline at Study Month 9

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel88
Standard of Care Therapy39
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel11.419.9Not reportedNot reportedNot reported
Standard of Care Therapy4.419.0Not reportedNot reportedNot reported
Change from Baseline at Study Month 12

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel80
Standard of Care Therapy31
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel10.119.9Not reportedNot reportedNot reported
Standard of Care Therapy6.617.8Not reportedNot reportedNot reported
Change from Baseline at Study Month 15

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel67
Standard of Care Therapy26
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel10.720.7Not reportedNot reportedNot reported
Standard of Care Therapy8.213.7Not reportedNot reportedNot reported
Change from Baseline at Study Month 18

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel70
Standard of Care Therapy23
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel15.117.1Not reportedNot reportedNot reported
Standard of Care Therapy9.313.6Not reportedNot reportedNot reported
Change from Baseline at Study Month 21

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel45
Standard of Care Therapy20
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel14.017.2Not reportedNot reportedNot reported
Standard of Care Therapy10.114.3Not reportedNot reportedNot reported
Change from Baseline at Study Month 24

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel33
Standard of Care Therapy12
Values in Score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel10.918.8Not reportedNot reportedNot reported
Standard of Care Therapy12.215.3Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    8.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    18.8
    group Description
    Difference in mean change of scores from Baseline at Day 100.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    False Discovery Rate Methodology
    param Type
    Mixed Model with Repeated Measures
    param Value
    13.7
    statistical Comment
    Mixed Model with Repeated Measures Differences in Change from Baseline.
    statistical Method
    Mixed Model with Repeated Measures
  2. ci Lower Limit
    5.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    17.1
    group Description
    Difference in mean change of scores from Baseline at Day 150.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0004
    p Value Comment
    False Discovery Rate Methodology
    param Type
    Mixed Model with Repeated Measures
    param Value
    11.3
    statistical Method
    Mixed Model with Repeated Measures
  3. ci Lower Limit
    -2.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.0
    group Description
    Difference in mean change of scores from Baseline at Month 9.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2549
    p Value Comment
    False Discovery Rate Methodology.
    param Type
    Mixed Model with Repeated Measures
    param Value
    3.8
    statistical Comment
    Mixed Model with Repeated Measures Differences in Change from Baseline.
    statistical Method
    Mixed Model with Repeated Measures
Complete source fields
analyses
  1. ci Lower Limit
    8.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    18.8
    group Description
    Difference in mean change of scores from Baseline at Day 100.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    False Discovery Rate Methodology
    param Type
    Mixed Model with Repeated Measures
    param Value
    13.7
    statistical Comment
    Mixed Model with Repeated Measures Differences in Change from Baseline.
    statistical Method
    Mixed Model with Repeated Measures
  2. ci Lower Limit
    5.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    17.1
    group Description
    Difference in mean change of scores from Baseline at Day 150.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0004
    p Value Comment
    False Discovery Rate Methodology
    param Type
    Mixed Model with Repeated Measures
    param Value
    11.3
    statistical Method
    Mixed Model with Repeated Measures
  3. ci Lower Limit
    -2.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.0
    group Description
    Difference in mean change of scores from Baseline at Month 9.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2549
    p Value Comment
    False Discovery Rate Methodology.
    param Type
    Mixed Model with Repeated Measures
    param Value
    3.8
    statistical Comment
    Mixed Model with Repeated Measures Differences in Change from Baseline.
    statistical Method
    Mixed Model with Repeated Measures
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.7
        value
        72.4
      2. group Id
        OG001
        spread
        20.1
        value
        74.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        165
      2. group Id
        OG001
        value
        129
      units
      Participants
    title
    Score at Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.7
        value
        -1.9
      2. group Id
        OG001
        spread
        16.7
        value
        -4.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        163
      2. group Id
        OG001
        value
        124
      units
      Participants
    title
    Change from Baseline at Study Day 50
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.4
        value
        4.0
      2. group Id
        OG001
        spread
        19.8
        value
        -8.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        145
      2. group Id
        OG001
        value
        64
      units
      Participants
    title
    Change from Baseline at Study Day 100
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.4
        value
        9.1
      2. group Id
        OG001
        spread
        22.2
        value
        -2.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        110
      2. group Id
        OG001
        value
        54
      units
      Participants
    title
    Change from Baseline at Study Day 150
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.9
        value
        11.4
      2. group Id
        OG001
        spread
        19.0
        value
        4.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        39
      units
      Participants
    title
    Change from Baseline at Study Month 9
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.9
        value
        10.1
      2. group Id
        OG001
        spread
        17.8
        value
        6.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        80
      2. group Id
        OG001
        value
        31
      units
      Participants
    title
    Change from Baseline at Study Month 12
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.7
        value
        10.7
      2. group Id
        OG001
        spread
        13.7
        value
        8.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        26
      units
      Participants
    title
    Change from Baseline at Study Month 15
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.1
        value
        15.1
      2. group Id
        OG001
        spread
        13.6
        value
        9.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        70
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    Change from Baseline at Study Month 18
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.2
        value
        14.0
      2. group Id
        OG001
        spread
        14.3
        value
        10.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        20
      units
      Participants
    title
    Change from Baseline at Study Month 21
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.8
        value
        10.9
      2. group Id
        OG001
        spread
        15.3
        value
        12.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Change from Baseline at Study Month 24
denoms
  1. counts
    1. group Id
      OG000
      value
      165
    2. group Id
      OG001
      value
      129
    units
    Participants
description
The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). The value 100 indicates improvement.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
    id
    OG000
    title
    Axicabtagene Ciloleucel
  2. description
    Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
    id
    OG001
    title
    Standard of Care Therapy
param Type
MEAN
population Description
Participants in QoL analysis set with data available at given timepoint were analyzed.
reporting Status
POSTED
time Frame
Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24
title
Change From Baseline in EQ-5D-5L VAS Scale Score
type
SECONDARY
unit Of Measure
Score on scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice