NCT03568461 · OUTCOME
Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire Reported by Change From Baseline
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), M3 change from baseline (CFB), M6 CFB, M9 CFB, M12 CFB, M18 CFB, M24 CFB, M36 CFB
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 - The Lym Subscale
The calculated Lym-subscale expressed by participants.
CTL019 - FACT-Lyphoma 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-Lyphoma Total Score
The total FACT-Lymphoma 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
| Group | Source count |
|---|
| CTL019 - Emotional Well-Being | 77 |
|---|
| CTL019 - Functional Well-Being | 77 |
|---|
| CTL019 - Physiscal Well-Being | 77 |
|---|
| CTL019 - Social/Family Well-Being | 77 |
|---|
| CTL019 - The Lym Subscale | 77 |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 77 |
|---|
| FACT-G Total Score | 77 |
|---|
| FACT-Lyphoma Total Score | 77 |
|---|
Reported measurements
Baseline (BL)
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019 - Emotional Well-Being | 77 |
|---|
| CTL019 - Functional Well-Being | 77 |
|---|
| CTL019 - Physiscal Well-Being | 77 |
|---|
| CTL019 - Social/Family Well-Being | 77 |
|---|
| CTL019 - The Lym Subscale | 77 |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 77 |
|---|
| FACT-G Total Score | 77 |
|---|
| FACT-Lyphoma Total Score | 77 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019 - Emotional Well-Being | 17.8 | 4.12 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Functional Well-Being | 18.8 | 5.47 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Physiscal Well-Being | 22.4 | 4.97 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Social/Family Well-Being | 22.3 | 5.42 | Not reported | Not reported | Not reported |
|---|
| CTL019 - The Lym Subscale | 45.5 | 8.57 | Not reported | Not reported | Not reported |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 86.7 | 16.54 | Not reported | Not reported | Not reported |
|---|
| FACT-G Total Score | 81.2 | 15.54 | Not reported | Not reported | Not reported |
|---|
| FACT-Lyphoma Total Score | 126.7 | 22.50 | Not reported | Not reported | Not reported |
|---|
M3 Change from baseline (CFB)
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019 - Emotional Well-Being | 62 |
|---|
| CTL019 - Functional Well-Being | 61 |
|---|
| CTL019 - Physiscal Well-Being | 62 |
|---|
| CTL019 - Social/Family Well-Being | 62 |
|---|
| CTL019 - The Lym Subscale | 62 |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 61 |
|---|
| FACT-G Total Score | 61 |
|---|
| FACT-Lyphoma Total Score | 61 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019 - Emotional Well-Being | 1.1 | 4.00 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Functional Well-Being | 0.2 | 5.04 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Physiscal Well-Being | 0.8 | 3.75 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Social/Family Well-Being | 0.1 | 3.35 | Not reported | Not reported | Not reported |
|---|
| CTL019 - The Lym Subscale | 1.8 | 7.11 | Not reported | Not reported | Not reported |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 2.8 | 13.75 | Not reported | Not reported | Not reported |
|---|
| FACT-G Total Score | 2.2 | 11.10 | Not reported | Not reported | Not reported |
|---|
| FACT-Lyphoma Total Score | 4.1 | 16.91 | Not reported | Not reported | Not reported |
|---|
M6 CFB
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019 - Emotional Well-Being | 60 |
|---|
| CTL019 - Functional Well-Being | 60 |
|---|
| CTL019 - Physiscal Well-Being | 60 |
|---|
| CTL019 - Social/Family Well-Being | 60 |
|---|
| CTL019 - The Lym Subscale | 60 |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 60 |
|---|
| FACT-G Total Score | 60 |
|---|
| FACT-Lyphoma Total Score | 60 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019 - Emotional Well-Being | 0.9 | 3.48 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Functional Well-Being | -0.6 | 5.69 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Physiscal Well-Being | 1.0 | 4.17 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Social/Family Well-Being | -1.6 | 4.57 | Not reported | Not reported | Not reported |
|---|
| CTL019 - The Lym Subscale | 2.2 | 7.17 | Not reported | Not reported | Not reported |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 2.6 | 14.65 | Not reported | Not reported | Not reported |
|---|
| FACT-G Total Score | -0.3 | 13.26 | Not reported | Not reported | Not reported |
|---|
| FACT-Lyphoma Total Score | 1.9 | 18.59 | Not reported | Not reported | Not reported |
|---|
M9 CFB
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019 - Emotional Well-Being | 40 |
|---|
| CTL019 - Functional Well-Being | 40 |
|---|
| CTL019 - Physiscal Well-Being | 40 |
|---|
| CTL019 - Social/Family Well-Being | 40 |
|---|
| CTL019 - The Lym Subscale | 40 |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 40 |
|---|
| FACT-G Total Score | 40 |
|---|
| FACT-Lyphoma Total Score | 40 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019 - Emotional Well-Being | 1.0 | 3.03 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Functional Well-Being | -0.3 | 5.81 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Physiscal Well-Being | -0.1 | 2.90 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Social/Family Well-Being | -1.9 | 4.69 | Not reported | Not reported | Not reported |
|---|
| CTL019 - The Lym Subscale | 0.6 | 5.63 | Not reported | Not reported | Not reported |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 0.3 | 11.38 | Not reported | Not reported | Not reported |
|---|
| FACT-G Total Score | -1.3 | 12.08 | Not reported | Not reported | Not reported |
|---|
| FACT-Lyphoma Total Score | -0.6 | 15.92 | Not reported | Not reported | Not reported |
|---|
M12 CFB
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019 - Emotional Well-Being | 43 |
|---|
| CTL019 - Functional Well-Being | 43 |
|---|
| CTL019 - Physiscal Well-Being | 43 |
|---|
| CTL019 - Social/Family Well-Being | 43 |
|---|
| CTL019 - The Lym Subscale | 43 |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 43 |
|---|
| FACT-G Total Score | 43 |
|---|
| FACT-Lyphoma Total Score | 43 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019 - Emotional Well-Being | 1.0 | 2.78 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Functional Well-Being | -0.5 | 4.33 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Physiscal Well-Being | 0.7 | 2.63 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Social/Family Well-Being | -1.3 | 4.62 | Not reported | Not reported | Not reported |
|---|
| CTL019 - The Lym Subscale | 2.1 | 4.62 | Not reported | Not reported | Not reported |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 2.3 | 9.14 | Not reported | Not reported | Not reported |
|---|
| FACT-G Total Score | -0.0 | 10.43 | Not reported | Not reported | Not reported |
|---|
| FACT-Lyphoma Total Score | 2.0 | 13.33 | Not reported | Not reported | Not reported |
|---|
M18 CFB
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019 - Emotional Well-Being | 44 |
|---|
| CTL019 - Functional Well-Being | 44 |
|---|
| CTL019 - Physiscal Well-Being | 44 |
|---|
| CTL019 - Social/Family Well-Being | 44 |
|---|
| CTL019 - The Lym Subscale | 44 |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 44 |
|---|
| FACT-G Total Score | 44 |
|---|
| FACT-Lyphoma Total Score | 44 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019 - Emotional Well-Being | 1.9 | 3.81 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Functional Well-Being | 0.5 | 5.65 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Physiscal Well-Being | 0.9 | 3.71 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Social/Family Well-Being | -0.7 | 5.10 | Not reported | Not reported | Not reported |
|---|
| CTL019 - The Lym Subscale | 2.2 | 6.44 | Not reported | Not reported | Not reported |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 3.5 | 12.66 | Not reported | Not reported | Not reported |
|---|
| FACT-G Total Score | 2.5 | 13.27 | Not reported | Not reported | Not reported |
|---|
| FACT-Lyphoma Total Score | 4.7 | 17.51 | Not reported | Not reported | Not reported |
|---|
M24 CFB
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019 - Emotional Well-Being | 40 |
|---|
| CTL019 - Functional Well-Being | 40 |
|---|
| CTL019 - Physiscal Well-Being | 40 |
|---|
| CTL019 - Social/Family Well-Being | 40 |
|---|
| CTL019 - The Lym Subscale | 40 |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 40 |
|---|
| FACT-G Total Score | 40 |
|---|
| FACT-Lyphoma Total Score | 40 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019 - Emotional Well-Being | 1.8 | 3.42 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Functional Well-Being | -0.0 | 6.10 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Physiscal Well-Being | 0.9 | 3.34 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Social/Family Well-Being | -0.8 | 5.88 | Not reported | Not reported | Not reported |
|---|
| CTL019 - The Lym Subscale | 2.1 | 6.09 | Not reported | Not reported | Not reported |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 3.0 | 12.78 | Not reported | Not reported | Not reported |
|---|
| FACT-G Total Score | 1.8 | 13.75 | Not reported | Not reported | Not reported |
|---|
| FACT-Lyphoma Total Score | 3.9 | 18.15 | Not reported | Not reported | Not reported |
|---|
M36 CFB
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019 - Emotional Well-Being | 22 |
|---|
| CTL019 - Functional Well-Being | 22 |
|---|
| CTL019 - Physiscal Well-Being | 22 |
|---|
| CTL019 - Social/Family Well-Being | 22 |
|---|
| CTL019 - The Lym Subscale | 22 |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 22 |
|---|
| FACT-G Total Score | 22 |
|---|
| FACT-Lyphoma Total Score | 22 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019 - Emotional Well-Being | 2.2 | 2.83 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Functional Well-Being | 0.6 | 3.90 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Physiscal Well-Being | 1.4 | 2.52 | Not reported | Not reported | Not reported |
|---|
| CTL019 - Social/Family Well-Being | -0.6 | 5.53 | Not reported | Not reported | Not reported |
|---|
| CTL019 - The Lym Subscale | 2.5 | 4.60 | Not reported | Not reported | Not reported |
|---|
| CTL019 - FACT-Lyphoma Trial Outcome Index | 4.4 | 8.65 | Not reported | Not reported | Not reported |
|---|
| FACT-G Total Score | 3.6 | 10.72 | Not reported | Not reported | Not reported |
|---|
| FACT-Lyphoma Total Score | 6.0 | 13.19 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 4.12
- value
- 17.8
- group Id
- OG001
- spread
- 5.47
- value
- 18.8
- group Id
- OG002
- spread
- 4.97
- value
- 22.4
- group Id
- OG003
- spread
- 5.42
- value
- 22.3
- group Id
- OG004
- spread
- 8.57
- value
- 45.5
- group Id
- OG005
- spread
- 16.54
- value
- 86.7
- group Id
- OG006
- spread
- 15.54
- value
- 81.2
- group Id
- OG007
- spread
- 22.50
- value
- 126.7
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 77
- group Id
- OG002
- value
- 77
- group Id
- OG003
- value
- 77
- group Id
- OG004
- value
- 77
- group Id
- OG005
- value
- 77
- group Id
- OG006
- value
- 77
- group Id
- OG007
- value
- 77
- units
- Participants
- title
- Baseline (BL)
- categories
- measurements
- group Id
- OG000
- spread
- 4.00
- value
- 1.1
- group Id
- OG001
- spread
- 5.04
- value
- 0.2
- group Id
- OG002
- spread
- 3.75
- value
- 0.8
- group Id
- OG003
- spread
- 3.35
- value
- 0.1
- group Id
- OG004
- spread
- 7.11
- value
- 1.8
- group Id
- OG005
- spread
- 13.75
- value
- 2.8
- group Id
- OG006
- spread
- 11.10
- value
- 2.2
- group Id
- OG007
- spread
- 16.91
- value
- 4.1
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 61
- group Id
- OG002
- value
- 62
- group Id
- OG003
- value
- 62
- group Id
- OG004
- value
- 62
- group Id
- OG005
- value
- 61
- group Id
- OG006
- value
- 61
- group Id
- OG007
- value
- 61
- units
- Participants
- title
- M3 Change from baseline (CFB)
- categories
- measurements
- group Id
- OG000
- spread
- 3.48
- value
- 0.9
- group Id
- OG001
- spread
- 5.69
- value
- -0.6
- group Id
- OG002
- spread
- 4.17
- value
- 1.0
- group Id
- OG003
- spread
- 4.57
- value
- -1.6
- group Id
- OG004
- spread
- 7.17
- value
- 2.2
- group Id
- OG005
- spread
- 14.65
- value
- 2.6
- group Id
- OG006
- spread
- 13.26
- value
- -0.3
- group Id
- OG007
- spread
- 18.59
- value
- 1.9
- denoms
- counts
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 60
- group Id
- OG002
- value
- 60
- group Id
- OG003
- value
- 60
- group Id
- OG004
- value
- 60
- group Id
- OG005
- value
- 60
- group Id
- OG006
- value
- 60
- group Id
- OG007
- value
- 60
- units
- Participants
- title
- M6 CFB
- categories
- measurements
- group Id
- OG000
- spread
- 3.03
- value
- 1.0
- group Id
- OG001
- spread
- 5.81
- value
- -0.3
- group Id
- OG002
- spread
- 2.90
- value
- -0.1
- group Id
- OG003
- spread
- 4.69
- value
- -1.9
- group Id
- OG004
- spread
- 5.63
- value
- 0.6
- group Id
- OG005
- spread
- 11.38
- value
- 0.3
- group Id
- OG006
- spread
- 12.08
- value
- -1.3
- group Id
- OG007
- spread
- 15.92
- value
- -0.6
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 40
- group Id
- OG003
- value
- 40
- group Id
- OG004
- value
- 40
- group Id
- OG005
- value
- 40
- group Id
- OG006
- value
- 40
- group Id
- OG007
- value
- 40
- units
- Participants
- title
- M9 CFB
- categories
- measurements
- group Id
- OG000
- spread
- 2.78
- value
- 1.0
- group Id
- OG001
- spread
- 4.33
- value
- -0.5
- group Id
- OG002
- spread
- 2.63
- value
- 0.7
- group Id
- OG003
- spread
- 4.62
- value
- -1.3
- group Id
- OG004
- spread
- 4.62
- value
- 2.1
- group Id
- OG005
- spread
- 9.14
- value
- 2.3
- group Id
- OG006
- spread
- 10.43
- value
- -0.0
- group Id
- OG007
- spread
- 13.33
- value
- 2.0
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 43
- group Id
- OG002
- value
- 43
- group Id
- OG003
- value
- 43
- group Id
- OG004
- value
- 43
- group Id
- OG005
- value
- 43
- group Id
- OG006
- value
- 43
- group Id
- OG007
- value
- 43
- units
- Participants
- title
- M12 CFB
- categories
- measurements
- group Id
- OG000
- spread
- 3.81
- value
- 1.9
- group Id
- OG001
- spread
- 5.65
- value
- 0.5
- group Id
- OG002
- spread
- 3.71
- value
- 0.9
- group Id
- OG003
- spread
- 5.10
- value
- -0.7
- group Id
- OG004
- spread
- 6.44
- value
- 2.2
- group Id
- OG005
- spread
- 12.66
- value
- 3.5
- group Id
- OG006
- spread
- 13.27
- value
- 2.5
- group Id
- OG007
- spread
- 17.51
- value
- 4.7
- denoms
- counts
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 44
- group Id
- OG003
- value
- 44
- group Id
- OG004
- value
- 44
- group Id
- OG005
- value
- 44
- group Id
- OG006
- value
- 44
- group Id
- OG007
- value
- 44
- units
- Participants
- title
- M18 CFB
- categories
- measurements
- group Id
- OG000
- spread
- 3.42
- value
- 1.8
- group Id
- OG001
- spread
- 6.10
- value
- -0.0
- group Id
- OG002
- spread
- 3.34
- value
- 0.9
- group Id
- OG003
- spread
- 5.88
- value
- -0.8
- group Id
- OG004
- spread
- 6.09
- value
- 2.1
- group Id
- OG005
- spread
- 12.78
- value
- 3.0
- group Id
- OG006
- spread
- 13.75
- value
- 1.8
- group Id
- OG007
- spread
- 18.15
- value
- 3.9
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 40
- group Id
- OG003
- value
- 40
- group Id
- OG004
- value
- 40
- group Id
- OG005
- value
- 40
- group Id
- OG006
- value
- 40
- group Id
- OG007
- value
- 40
- units
- Participants
- title
- M24 CFB
- categories
- measurements
- group Id
- OG000
- spread
- 2.83
- value
- 2.2
- group Id
- OG001
- spread
- 3.90
- value
- 0.6
- group Id
- OG002
- spread
- 2.52
- value
- 1.4
- group Id
- OG003
- spread
- 5.53
- value
- -0.6
- group Id
- OG004
- spread
- 4.60
- value
- 2.5
- group Id
- OG005
- spread
- 8.65
- value
- 4.4
- group Id
- OG006
- spread
- 10.72
- value
- 3.6
- group Id
- OG007
- spread
- 13.19
- value
- 6.0
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 22
- group Id
- OG005
- value
- 22
- group Id
- OG006
- value
- 22
- group Id
- OG007
- value
- 22
- units
- Participants
- title
- M36 CFB
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 77
- group Id
- OG002
- value
- 77
- group Id
- OG003
- value
- 77
- group Id
- OG004
- value
- 77
- group Id
- OG005
- value
- 77
- group Id
- OG006
- value
- 77
- 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
- description
- Participants expressed their emotional well-being.
- id
- OG000
- title
- CTL019 - Emotional Well-Being
- description
- Participants expressed their efunctional well-being.
- id
- OG001
- title
- CTL019 - Functional Well-Being
- description
- Participants expressed their physical well-being.
- id
- OG002
- title
- CTL019 - Physiscal Well-Being
- description
- Participants expressed their social/family well-being.
- id
- OG003
- title
- CTL019 - Social/Family Well-Being
- description
- The calculated Lym-subscale expressed by participants.
- id
- OG004
- title
- CTL019 - The Lym Subscale
- description
- The calculated FACT-Lymphoma trial outcome index expressed by participants.
- id
- OG005
- title
- CTL019 - FACT-Lyphoma Trial Outcome Index
- description
- The FACTG total score expressed by the participants.
- id
- OG006
- title
- FACT-G Total Score
- description
- The total FACT-Lymphoma score expressed by the participants.
- id
- OG007
- title
- FACT-Lyphoma 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), M3 change from baseline (CFB), M6 CFB, M9 CFB, M12 CFB, M18 CFB, M24 CFB, M36 CFB
- title
- Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire Reported by Change From Baseline
- type
- SECONDARY
- unit Of Measure
- scores on a scale
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Preserved source evidence · Not medical advice
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