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NCT03568461 · OUTCOME

Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire

Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma · Source last updated 2026-07-09

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

Measure
MEAN
Unit
scores on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline (BL) Month (M) 3, M6, M9, M12, M18, M24, M36

What was measured

The effect of tisagenlecleucel therapy on patient-reported outcomes was assessed using the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire, which measures quality of life in participants with lymphoma. FACT-Lym is composed of the FACT-G (27 items across Physical, Social/Family, Emotional, and Functional Well-Being, plus Additional Concerns) and a 15-item lymphoma-specific subscale. All items use a five-point self-administered response scale (0-4), with higher scores indicating better quality of life. The possible score ranges are as follows: - Physical Well-Being (PWB): 0-28 - Social/Family Well-Being (SWB): 0-28 - Emotional Well-Being (EWB): 0-24 - Functional Well-Being (FWB): 0-28 - Lym Subscale (15 items): 0-60 - Lymphoma Trial Outcome Index (TOI: PWB + FWB + Lym): 0-116 - FACT-G Total (PWB + SWB + EWB + FWB): 0-108 - FACT-Lym Total (FACT-G + Lym): 0-168 In all cases, higher scores indicate better outcomes within the corresponding domain.

Analysis population: Efficacy analysis set (EAS): The number of participants in the EAS with an available value at each visit. EAS comprised of all participants who received tisagenlecleucel, and had measurable disease at baseline per IRC. Non-measurable disease at baseline is defined as absence of index lesion at baseline disease evaluation (i.e. no disease at baseline).

Groups in this outcome

CTL019 - Emotional Well-Being

Participants expressed their emotional well-being.

CTL019 - Functional Well-Being

Participants expressed their efunctional well-being.

CTL019 - Physiscal Well-Being

Participants expressed their physical well-being.

CTL019 - Social/Family Well-Being

Participants expressed their social/family well-being.

CTL019 - FACT-Lym Subscale

The calculated Lym-subscale expressed by participants.

CTL019 - FACT-Lym Trial Outcome Index

The calculated FACT-Lymphoma trial outcome index expressed by participants.

FACT-G Total Score

The FACTG total score expressed by the participants.

FACT-Lym Total Score

The total FACT-Lym score expressed by the participants.

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

Analysis denominator · Participants

GroupSource count
CTL019 - Emotional Well-Being77
CTL019 - Functional Well-Being77
CTL019 - Physiscal Well-Being77
CTL019 - Social/Family Well-Being77
CTL019 - FACT-Lym Subscale77
CTL019 - FACT-Lym Trial Outcome Index77
FACT-G Total Score77
FACT-Lym Total Score77

Reported measurements

Baseline (BL)

Analysis denominator · Participants

GroupSource count
CTL019 - Emotional Well-Being77
CTL019 - Functional Well-Being77
CTL019 - Physiscal Well-Being77
CTL019 - Social/Family Well-Being77
CTL019 - FACT-Lym Subscale77
CTL019 - FACT-Lym Trial Outcome Index77
FACT-G Total Score77
FACT-Lym Total Score77
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019 - Emotional Well-Being17.84.12Not reportedNot reportedNot reported
CTL019 - Functional Well-Being18.85.47Not reportedNot reportedNot reported
CTL019 - Physiscal Well-Being22.44.97Not reportedNot reportedNot reported
CTL019 - Social/Family Well-Being22.35.42Not reportedNot reportedNot reported
CTL019 - FACT-Lym Subscale45.58.57Not reportedNot reportedNot reported
CTL019 - FACT-Lym Trial Outcome Index86.716.54Not reportedNot reportedNot reported
FACT-G Total Score81.215.54Not reportedNot reportedNot reported
FACT-Lym Total Score126.722.50Not reportedNot reportedNot reported
Month (M) 3

Analysis denominator · Participants

GroupSource count
CTL019 - Emotional Well-Being68
CTL019 - Functional Well-Being67
CTL019 - Physiscal Well-Being68
CTL019 - Social/Family Well-Being68
CTL019 - FACT-Lym Subscale68
CTL019 - FACT-Lym Trial Outcome Index67
FACT-G Total Score67
FACT-Lym Total Score67
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019 - Emotional Well-Being19.14.24Not reportedNot reportedNot reported
CTL019 - Functional Well-Being19.45.76Not reportedNot reportedNot reported
CTL019 - Physiscal Well-Being23.94.72Not reportedNot reportedNot reported
CTL019 - Social/Family Well-Being22.84.72Not reportedNot reportedNot reported
CTL019 - FACT-Lym Subscale48.38.18Not reportedNot reportedNot reported
CTL019 - FACT-Lym Trial Outcome Index91.417.04Not reportedNot reportedNot reported
FACT-G Total Score85.115.41Not reportedNot reportedNot reported
FACT-Lym Total Score133.322.63Not reportedNot reportedNot reported
M6

Analysis denominator · Participants

GroupSource count
CTL019 - Emotional Well-Being65
CTL019 - Functional Well-Being65
CTL019 - Physiscal Well-Being65
CTL019 - Social/Family Well-Being65
CTL019 - FACT-Lym Subscale65
CTL019 - FACT-Lym Trial Outcome Index65
FACT-G Total Score65
FACT-Lym Total Score65
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019 - Emotional Well-Being18.04.27Not reportedNot reportedNot reported
CTL019 - Functional Well-Being17.95.98Not reportedNot reportedNot reported
CTL019 - Physiscal Well-Being23.14.41Not reportedNot reportedNot reported
CTL019 - Social/Family Well-Being20.26.63Not reportedNot reportedNot reported
CTL019 - FACT-Lym Subscale47.08.59Not reportedNot reportedNot reported
CTL019 - FACT-Lym Trial Outcome Index87.916.86Not reportedNot reportedNot reported
FACT-G Total Score79.217.06Not reportedNot reportedNot reported
FACT-Lym Total Score126.124.06Not reportedNot reportedNot reported
M9

Analysis denominator · Participants

GroupSource count
CTL019 - Emotional Well-Being45
CTL019 - Functional Well-Being45
CTL019 - Physiscal Well-Being45
CTL019 - Social/Family Well-Being45
CTL019 - FACT-Lym Subscale45
CTL019 - FACT-Lym Trial Outcome Index45
FACT-G Total Score45
FACT-Lym Total Score45
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019 - Emotional Well-Being18.54.26Not reportedNot reportedNot reported
CTL019 - Functional Well-Being18.15.60Not reportedNot reportedNot reported
CTL019 - Physiscal Well-Being22.95.14Not reportedNot reportedNot reported
CTL019 - Social/Family Well-Being19.66.44Not reportedNot reportedNot reported
CTL019 - FACT-Lym Subscale47.08.39Not reportedNot reportedNot reported
CTL019 - FACT-Lym Trial Outcome Index88.016.70Not reportedNot reportedNot reported
FACT-G Total Score79.117.36Not reportedNot reportedNot reported
FACT-Lym Total Score126.124.13Not reportedNot reportedNot reported
M12

Analysis denominator · Participants

GroupSource count
CTL019 - Emotional Well-Being49
CTL019 - Functional Well-Being49
CTL019 - Physiscal Well-Being49
CTL019 - Social/Family Well-Being49
CTL019 - FACT-Lym Subscale49
CTL019 - FACT-Lym Trial Outcome Index49
FACT-G Total Score49
FACT-Lym Total Score49
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019 - Emotional Well-Being19.03.81Not reportedNot reportedNot reported
CTL019 - Functional Well-Being18.85.50Not reportedNot reportedNot reported
CTL019 - Physiscal Well-Being23.74.67Not reportedNot reportedNot reported
CTL019 - Social/Family Well-Being20.96.08Not reportedNot reportedNot reported
CTL019 - FACT-Lym Subscale48.56.92Not reportedNot reportedNot reported
CTL019 - FACT-Lym Trial Outcome Index91.015.22Not reportedNot reportedNot reported
FACT-G Total Score82.315.65Not reportedNot reportedNot reported
FACT-Lym Total Score130.821.32Not reportedNot reportedNot reported
M18

Analysis denominator · Participants

GroupSource count
CTL019 - Emotional Well-Being50
CTL019 - Functional Well-Being50
CTL019 - Physiscal Well-Being50
CTL019 - Social/Family Well-Being50
CTL019 - FACT-Lym Subscale50
CTL019 - FACT-Lym Trial Outcome Index50
FACT-G Total Score50
FACT-Lym Total Score50
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019 - Emotional Well-Being19.44.39Not reportedNot reportedNot reported
CTL019 - Functional Well-Being18.86.87Not reportedNot reportedNot reported
CTL019 - Physiscal Well-Being23.14.75Not reportedNot reportedNot reported
CTL019 - Social/Family Well-Being21.37.03Not reportedNot reportedNot reported
CTL019 - FACT-Lym Subscale47.98.80Not reportedNot reportedNot reported
CTL019 - FACT-Lym Trial Outcome Index89.818.34Not reportedNot reportedNot reported
FACT-G Total Score82.519.31Not reportedNot reportedNot reported
FACT-Lym Total Score130.526.77Not reportedNot reportedNot reported
M24

Analysis denominator · Participants

GroupSource count
CTL019 - Emotional Well-Being47
CTL019 - Functional Well-Being47
CTL019 - Physiscal Well-Being47
CTL019 - Social/Family Well-Being47
CTL019 - FACT-Lym Subscale47
CTL019 - FACT-Lym Trial Outcome Index47
FACT-G Total Score47
FACT-Lym Total Score47
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019 - Emotional Well-Being19.24.67Not reportedNot reportedNot reported
CTL019 - Functional Well-Being18.16.14Not reportedNot reportedNot reported
CTL019 - Physiscal Well-Being23.25.17Not reportedNot reportedNot reported
CTL019 - Social/Family Well-Being21.36.35Not reportedNot reportedNot reported
CTL019 - FACT-Lym Subscale47.49.12Not reportedNot reportedNot reported
CTL019 - FACT-Lym Trial Outcome Index88.718.06Not reportedNot reportedNot reported
FACT-G Total Score81.816.90Not reportedNot reportedNot reported
FACT-Lym Total Score129.224.83Not reportedNot reportedNot reported
M36

Analysis denominator · Participants

GroupSource count
CTL019 - Emotional Well-Being25
CTL019 - Functional Well-Being25
CTL019 - Physiscal Well-Being25
CTL019 - Social/Family Well-Being25
CTL019 - FACT-Lym Subscale25
CTL019 - FACT-Lym Trial Outcome Index25
FACT-G Total Score25
FACT-Lym Total Score25
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019 - Emotional Well-Being19.74.53Not reportedNot reportedNot reported
CTL019 - Functional Well-Being19.65.14Not reportedNot reportedNot reported
CTL019 - Physiscal Well-Being24.34.15Not reportedNot reportedNot reported
CTL019 - Social/Family Well-Being21.74.78Not reportedNot reportedNot reported
CTL019 - FACT-Lym Subscale48.78.14Not reportedNot reportedNot reported
CTL019 - FACT-Lym Trial Outcome Index92.615.45Not reportedNot reportedNot reported
FACT-G Total Score85.313.86Not reportedNot reportedNot reported
FACT-Lym Total Score134.020.87Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.12
        value
        17.8
      2. group Id
        OG001
        spread
        5.47
        value
        18.8
      3. group Id
        OG002
        spread
        4.97
        value
        22.4
      4. group Id
        OG003
        spread
        5.42
        value
        22.3
      5. group Id
        OG004
        spread
        8.57
        value
        45.5
      6. group Id
        OG005
        spread
        16.54
        value
        86.7
      7. group Id
        OG006
        spread
        15.54
        value
        81.2
      8. group Id
        OG007
        spread
        22.50
        value
        126.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        77
      2. group Id
        OG001
        value
        77
      3. group Id
        OG002
        value
        77
      4. group Id
        OG003
        value
        77
      5. group Id
        OG004
        value
        77
      6. group Id
        OG005
        value
        77
      7. group Id
        OG006
        value
        77
      8. group Id
        OG007
        value
        77
      units
      Participants
    title
    Baseline (BL)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.24
        value
        19.1
      2. group Id
        OG001
        spread
        5.76
        value
        19.4
      3. group Id
        OG002
        spread
        4.72
        value
        23.9
      4. group Id
        OG003
        spread
        4.72
        value
        22.8
      5. group Id
        OG004
        spread
        8.18
        value
        48.3
      6. group Id
        OG005
        spread
        17.04
        value
        91.4
      7. group Id
        OG006
        spread
        15.41
        value
        85.1
      8. group Id
        OG007
        spread
        22.63
        value
        133.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      2. group Id
        OG001
        value
        67
      3. group Id
        OG002
        value
        68
      4. group Id
        OG003
        value
        68
      5. group Id
        OG004
        value
        68
      6. group Id
        OG005
        value
        67
      7. group Id
        OG006
        value
        67
      8. group Id
        OG007
        value
        67
      units
      Participants
    title
    Month (M) 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.27
        value
        18.0
      2. group Id
        OG001
        spread
        5.98
        value
        17.9
      3. group Id
        OG002
        spread
        4.41
        value
        23.1
      4. group Id
        OG003
        spread
        6.63
        value
        20.2
      5. group Id
        OG004
        spread
        8.59
        value
        47.0
      6. group Id
        OG005
        spread
        16.86
        value
        87.9
      7. group Id
        OG006
        spread
        17.06
        value
        79.2
      8. group Id
        OG007
        spread
        24.06
        value
        126.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      2. group Id
        OG001
        value
        65
      3. group Id
        OG002
        value
        65
      4. group Id
        OG003
        value
        65
      5. group Id
        OG004
        value
        65
      6. group Id
        OG005
        value
        65
      7. group Id
        OG006
        value
        65
      8. group Id
        OG007
        value
        65
      units
      Participants
    title
    M6
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.26
        value
        18.5
      2. group Id
        OG001
        spread
        5.60
        value
        18.1
      3. group Id
        OG002
        spread
        5.14
        value
        22.9
      4. group Id
        OG003
        spread
        6.44
        value
        19.6
      5. group Id
        OG004
        spread
        8.39
        value
        47.0
      6. group Id
        OG005
        spread
        16.70
        value
        88.0
      7. group Id
        OG006
        spread
        17.36
        value
        79.1
      8. group Id
        OG007
        spread
        24.13
        value
        126.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        45
      3. group Id
        OG002
        value
        45
      4. group Id
        OG003
        value
        45
      5. group Id
        OG004
        value
        45
      6. group Id
        OG005
        value
        45
      7. group Id
        OG006
        value
        45
      8. group Id
        OG007
        value
        45
      units
      Participants
    title
    M9
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.81
        value
        19.0
      2. group Id
        OG001
        spread
        5.50
        value
        18.8
      3. group Id
        OG002
        spread
        4.67
        value
        23.7
      4. group Id
        OG003
        spread
        6.08
        value
        20.9
      5. group Id
        OG004
        spread
        6.92
        value
        48.5
      6. group Id
        OG005
        spread
        15.22
        value
        91.0
      7. group Id
        OG006
        spread
        15.65
        value
        82.3
      8. group Id
        OG007
        spread
        21.32
        value
        130.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        49
      3. group Id
        OG002
        value
        49
      4. group Id
        OG003
        value
        49
      5. group Id
        OG004
        value
        49
      6. group Id
        OG005
        value
        49
      7. group Id
        OG006
        value
        49
      8. group Id
        OG007
        value
        49
      units
      Participants
    title
    M12
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.39
        value
        19.4
      2. group Id
        OG001
        spread
        6.87
        value
        18.8
      3. group Id
        OG002
        spread
        4.75
        value
        23.1
      4. group Id
        OG003
        spread
        7.03
        value
        21.3
      5. group Id
        OG004
        spread
        8.80
        value
        47.9
      6. group Id
        OG005
        spread
        18.34
        value
        89.8
      7. group Id
        OG006
        spread
        19.31
        value
        82.5
      8. group Id
        OG007
        spread
        26.77
        value
        130.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        50
      3. group Id
        OG002
        value
        50
      4. group Id
        OG003
        value
        50
      5. group Id
        OG004
        value
        50
      6. group Id
        OG005
        value
        50
      7. group Id
        OG006
        value
        50
      8. group Id
        OG007
        value
        50
      units
      Participants
    title
    M18
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.67
        value
        19.2
      2. group Id
        OG001
        spread
        6.14
        value
        18.1
      3. group Id
        OG002
        spread
        5.17
        value
        23.2
      4. group Id
        OG003
        spread
        6.35
        value
        21.3
      5. group Id
        OG004
        spread
        9.12
        value
        47.4
      6. group Id
        OG005
        spread
        18.06
        value
        88.7
      7. group Id
        OG006
        spread
        16.90
        value
        81.8
      8. group Id
        OG007
        spread
        24.83
        value
        129.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        47
      3. group Id
        OG002
        value
        47
      4. group Id
        OG003
        value
        47
      5. group Id
        OG004
        value
        47
      6. group Id
        OG005
        value
        47
      7. group Id
        OG006
        value
        47
      8. group Id
        OG007
        value
        47
      units
      Participants
    title
    M24
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.53
        value
        19.7
      2. group Id
        OG001
        spread
        5.14
        value
        19.6
      3. group Id
        OG002
        spread
        4.15
        value
        24.3
      4. group Id
        OG003
        spread
        4.78
        value
        21.7
      5. group Id
        OG004
        spread
        8.14
        value
        48.7
      6. group Id
        OG005
        spread
        15.45
        value
        92.6
      7. group Id
        OG006
        spread
        13.86
        value
        85.3
      8. group Id
        OG007
        spread
        20.87
        value
        134.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        25
      4. group Id
        OG003
        value
        25
      5. group Id
        OG004
        value
        25
      6. group Id
        OG005
        value
        25
      7. group Id
        OG006
        value
        25
      8. group Id
        OG007
        value
        25
      units
      Participants
    title
    M36
denoms
  1. counts
    1. group Id
      OG000
      value
      77
    2. group Id
      OG001
      value
      77
    3. group Id
      OG002
      value
      77
    4. group Id
      OG003
      value
      77
    5. group Id
      OG004
      value
      77
    6. group Id
      OG005
      value
      77
    7. group Id
      OG006
      value
      77
    8. group Id
      OG007
      value
      77
    units
    Participants
description
The effect of tisagenlecleucel therapy on patient-reported outcomes was assessed using the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) questionnaire, which measures quality of life in participants with lymphoma. FACT-Lym is composed of the FACT-G (27 items across Physical, Social/Family, Emotional, and Functional Well-Being, plus Additional Concerns) and a 15-item lymphoma-specific subscale. All items use a five-point self-administered response scale (0-4), with higher scores indicating better quality of life. The possible score ranges are as follows: - Physical Well-Being (PWB): 0-28 - Social/Family Well-Being (SWB): 0-28 - Emotional Well-Being (EWB): 0-24 - Functional Well-Being (FWB): 0-28 - Lym Subscale (15 items): 0-60 - Lymphoma Trial Outcome Index (TOI: PWB + FWB + Lym): 0-116 - FACT-G Total (PWB + SWB + EWB + FWB): 0-108 - FACT-Lym Total (FACT-G + Lym): 0-168 In all cases, higher scores indicate better outcomes within the corresponding domain.
dispersion Type
Standard Deviation
groups
  1. description
    Participants expressed their emotional well-being.
    id
    OG000
    title
    CTL019 - Emotional Well-Being
  2. description
    Participants expressed their efunctional well-being.
    id
    OG001
    title
    CTL019 - Functional Well-Being
  3. description
    Participants expressed their physical well-being.
    id
    OG002
    title
    CTL019 - Physiscal Well-Being
  4. description
    Participants expressed their social/family well-being.
    id
    OG003
    title
    CTL019 - Social/Family Well-Being
  5. description
    The calculated Lym-subscale expressed by participants.
    id
    OG004
    title
    CTL019 - FACT-Lym Subscale
  6. description
    The calculated FACT-Lymphoma trial outcome index expressed by participants.
    id
    OG005
    title
    CTL019 - FACT-Lym Trial Outcome Index
  7. description
    The FACTG total score expressed by the participants.
    id
    OG006
    title
    FACT-G Total Score
  8. description
    The total FACT-Lym score expressed by the participants.
    id
    OG007
    title
    FACT-Lym Total Score
param Type
MEAN
population Description
Efficacy analysis set (EAS): The number of participants in the EAS with an available value at each visit. EAS comprised of all participants who received tisagenlecleucel, and had measurable disease at baseline per IRC. Non-measurable disease at baseline is defined as absence of index lesion at baseline disease evaluation (i.e. no disease at baseline).
reporting Status
POSTED
time Frame
Baseline (BL) Month (M) 3, M6, M9, M12, M18, M24, M36
title
Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire
type
SECONDARY
unit Of Measure
scores on a scale

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Preserved source evidence · Not medical advice