NCT03568461 · OUTCOME
Summary Scores of PRO Measured by SF-36v2 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
- Change from baseline (CFB) M3, CFB M6, CFB M9, CFB M12, CFB M18, CFB M24
What was measured
Effect of tisagenlecleucel therapy on patient reported outcomes were reported using the Short Form Health Survey (SF-36) v2 form. The SF-36 v2 is a widely used and extensively studied instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) were computed by summing the item responses on the questions for each domain in accordance with the respective scoring method provided by the developers. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. A high score defines a more favorable health state.
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: Physical Health Total Score
All participants who were enrolled in the study
CTL019: Mental Health Total Score
All participants who were enrolled in the study
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: Physical Health Total Score | 77 |
|---|
| CTL019: Mental Health Total Score | 77 |
|---|
Reported measurements
Baseline (BL)
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019: Physical Health Total Score | 77 |
|---|
| CTL019: Mental Health Total Score | 77 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019: Physical Health Total Score | 48.234 | 8.6274 | Not reported | Not reported | Not reported |
|---|
| CTL019: Mental Health Total Score | 49.444 | 10.5072 | Not reported | Not reported | Not reported |
|---|
Change from BL (CFB) M3
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019: Physical Health Total Score | 61 |
|---|
| CTL019: Mental Health Total Score | 61 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019: Physical Health Total Score | -0.595 | 8.2149 | Not reported | Not reported | Not reported |
|---|
| CTL019: Mental Health Total Score | 1.973 | 10.1215 | Not reported | Not reported | Not reported |
|---|
CFB M6
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019: Physical Health Total Score | 60 |
|---|
| CTL019: Mental Health Total Score | 60 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019: Physical Health Total Score | 0.958 | 8.5319 | Not reported | Not reported | Not reported |
|---|
| CTL019: Mental Health Total Score | -0.112 | 10.1907 | Not reported | Not reported | Not reported |
|---|
CFB M9
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019: Physical Health Total Score | 38 |
|---|
| CTL019: Mental Health Total Score | 38 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019: Physical Health Total Score | -0.097 | 6.2945 | Not reported | Not reported | Not reported |
|---|
| CTL019: Mental Health Total Score | 0.133 | 7.6501 | Not reported | Not reported | Not reported |
|---|
CFB M12
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019: Physical Health Total Score | 43 |
|---|
| CTL019: Mental Health Total Score | 43 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019: Physical Health Total Score | 0.526 | 7.0491 | Not reported | Not reported | Not reported |
|---|
| CTL019: Mental Health Total Score | -1.140 | 8.9299 | Not reported | Not reported | Not reported |
|---|
CFB M18
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019: Physical Health Total Score | 44 |
|---|
| CTL019: Mental Health Total Score | 44 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019: Physical Health Total Score | 1.268 | 6.4476 | Not reported | Not reported | Not reported |
|---|
| CTL019: Mental Health Total Score | 0.069 | 10.9908 | Not reported | Not reported | Not reported |
|---|
CFB M24
Analysis denominator · Participants
| Group | Source count |
|---|
| CTL019: Physical Health Total Score | 40 |
|---|
| CTL019: Mental Health Total Score | 40 |
|---|
Values in scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| CTL019: Physical Health Total Score | -0.338 | 8.1708 | Not reported | Not reported | Not reported |
|---|
| CTL019: Mental Health Total Score | 1.857 | 10.5041 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 8.6274
- value
- 48.234
- group Id
- OG001
- spread
- 10.5072
- value
- 49.444
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 77
- units
- Participants
- title
- Baseline (BL)
- categories
- measurements
- group Id
- OG000
- spread
- 8.2149
- value
- -0.595
- group Id
- OG001
- spread
- 10.1215
- value
- 1.973
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 61
- units
- Participants
- title
- Change from BL (CFB) M3
- categories
- measurements
- group Id
- OG000
- spread
- 8.5319
- value
- 0.958
- group Id
- OG001
- spread
- 10.1907
- value
- -0.112
- denoms
- counts
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 60
- units
- Participants
- title
- CFB M6
- categories
- measurements
- group Id
- OG000
- spread
- 6.2945
- value
- -0.097
- group Id
- OG001
- spread
- 7.6501
- value
- 0.133
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 38
- units
- Participants
- title
- CFB M9
- categories
- measurements
- group Id
- OG000
- spread
- 7.0491
- value
- 0.526
- group Id
- OG001
- spread
- 8.9299
- value
- -1.140
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 43
- units
- Participants
- title
- CFB M12
- categories
- measurements
- group Id
- OG000
- spread
- 6.4476
- value
- 1.268
- group Id
- OG001
- spread
- 10.9908
- value
- 0.069
- denoms
- counts
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 44
- units
- Participants
- title
- CFB M18
- categories
- measurements
- group Id
- OG000
- spread
- 8.1708
- value
- -0.338
- group Id
- OG001
- spread
- 10.5041
- value
- 1.857
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 40
- units
- Participants
- title
- CFB M24
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 77
- units
- Participants
- description
- Effect of tisagenlecleucel therapy on patient reported outcomes were reported using the Short Form Health Survey (SF-36) v2 form. The SF-36 v2 is a widely used and extensively studied instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) were computed by summing the item responses on the questions for each domain in accordance with the respective scoring method provided by the developers. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. A high score defines a more favorable health state.
- dispersion Type
- Standard Deviation
- groups
- description
- All participants who were enrolled in the study
- id
- OG000
- title
- CTL019: Physical Health Total Score
- description
- All participants who were enrolled in the study
- id
- OG001
- title
- CTL019: Mental Health 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
- Change from baseline (CFB) M3, CFB M6, CFB M9, CFB M12, CFB M18, CFB M24
- title
- Summary Scores of PRO Measured by SF-36v2 Quality of Life Questionnaire Reported by Change From Baseline
- type
- SECONDARY
- unit Of Measure
- scores on a scale
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