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NCT03568461 · OUTCOME

Health Status Measured by EQ-5D-3L 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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Baseline (BL), Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 36

What was measured

Effect of tisagenlecleucel therapy on patient-reported outcomes was assessed using the EuroQol 5-Dimension, 3-Level instrument (EQ-5D-3L). The EQ-5D-3L is a widely used, self-administered questionnaire designed to evaluate health status in adults. It consists of two sections. The first includes one item for each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients rate each dimension as "no problems" (level 1), "some problems" (level 2), or "extreme problems" (level 3). This record summarizes, for each of the five dimensions, the number of patients falling into each response level.

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: EQ 5D 3L Dimensions by Visit - Level 1

Participants who had no problems

CTL019: EQ 5D 3L Dimensions by Visit - Level 2

Participants who had some problems

CTL019: EQ 5D 3L Dimensions by Visit -Level 3

Participants who had severe problems

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: EQ 5D 3L Dimensions by Visit - Level 1	76
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	76
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	76

Reported measurements

Baseline (BL) : Mobility

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	76
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	76
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	76

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	63	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	13	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Baseline (BL) : Self-care

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	76
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	76
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	76

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	70	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	6	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Baseline (BL) : Usual Activities

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	76
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	76
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	76

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	53	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	22	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	1	Not reported	Not reported	Not reported	Not reported

Baseline (BL) : Pain/Discomfort

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	76
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	76
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	76

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	45	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	29	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	2	Not reported	Not reported	Not reported	Not reported

Baseline (BL) : Anxiety/Depression

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	76
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	76
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	76

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	52	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	21	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	3	Not reported	Not reported	Not reported	Not reported

Month 3 : Mobility

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	64
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	64
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	64

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	52	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	12	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 3: Self-care

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	64
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	64
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	64

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	62	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	2	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 3: Usual Activities

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	64
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	64
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	64

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	48	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	16	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 3: Pain/Discomfort

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	64
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	64
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	64

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	35	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	26	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	3	Not reported	Not reported	Not reported	Not reported

Month 3: Anxiety/Depression

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	64
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	64
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	64

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	52	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	11	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	1	Not reported	Not reported	Not reported	Not reported

Month 6: Mobility

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	64
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	64
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	64

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	55	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	9	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 6: Self-care

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	64
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	64
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	64

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	61	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	3	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 6: Usual Activities

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	64
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	64
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	64

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	40	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	23	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	1	Not reported	Not reported	Not reported	Not reported

Month 6: Pain/Discomfort

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	64
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	64
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	64

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	36	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	24	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	4	Not reported	Not reported	Not reported	Not reported

Month 6: Anxiety/Depression

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	63
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	63
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	63

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	39	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	22	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	2	Not reported	Not reported	Not reported	Not reported

Month 9: Mobility

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	44
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	44
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	44

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	36	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	8	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 9: Self-care

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	44
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	44
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	44

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	42	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	2	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 9: Usual Activities

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	44
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	44
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	44

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	34	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	10	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 9: Pain/Discomfort

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	44
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	44
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	44

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	22	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	22	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 9: Anxiety/Depression

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	44
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	44
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	44

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	32	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	11	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	1	Not reported	Not reported	Not reported	Not reported

Month 12: Mobility

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	50
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	50
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	50

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	43	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	7	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 12: Self-care

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	50
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	50
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	50

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	48	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	2	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 12: Usual Activities

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	50
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	50
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	50

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	33	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	16	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	1	Not reported	Not reported	Not reported	Not reported

Month 12: Pain/Discomfort

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	50
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	50
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	50

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	29	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	20	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	1	Not reported	Not reported	Not reported	Not reported

Month 12: Anxiety/Depression

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	50
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	50
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	50

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	33	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	16	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	1	Not reported	Not reported	Not reported	Not reported

Month 18: Mobility

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	50
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	50
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	50

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	42	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	8	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 18: Self-care

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	50
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	50
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	50

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	47	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	3	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 18: Usual Activities

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	49
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	49
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	49

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	35	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	13	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	1	Not reported	Not reported	Not reported	Not reported

Month 18: Pain/Discomfort

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	49
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	49
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	49

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	21	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	27	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	1	Not reported	Not reported	Not reported	Not reported

Month 18: Anxiety/Depression

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	49
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	49
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	49

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	33	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	15	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	1	Not reported	Not reported	Not reported	Not reported

Month 24: Mobility:

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	47
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	47
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	47

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	33	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	14	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 24: Self-care

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	47
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	47
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	47

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	43	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	4	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 24: Usual Activities

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	47
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	47
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	47

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	30	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	16	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	1	Not reported	Not reported	Not reported	Not reported

Month 24: Pain/Discomfort

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	47
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	47
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	47

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	21	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	23	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	3	Not reported	Not reported	Not reported	Not reported

Month 24: Anxiety/Depression

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	47
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	47
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	47

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	32	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	14	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	1	Not reported	Not reported	Not reported	Not reported

Month 36: Mobility

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	21
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	21
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	18	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	3	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 36: Self-care

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	21
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	21
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	18	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	3	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 36: Usual Activities

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	21
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	21
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	15	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	6	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	0	Not reported	Not reported	Not reported	Not reported

Month 36: Pain/Discomfort

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	21
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	21
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	11	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	9	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	1	Not reported	Not reported	Not reported	Not reported

Month 36: Anxiety/Depression

Analysis denominator · Participants

Group	Source count
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	21
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	21
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	21

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CTL019: EQ 5D 3L Dimensions by Visit - Level 1	16	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit - Level 2	3	Not reported	Not reported	Not reported	Not reported
CTL019: EQ 5D 3L Dimensions by Visit -Level 3	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
63
group Id
OG001
value
13
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
76
group Id
OG001
value
76
group Id
OG002
value
76
units
Participants
title
Baseline (BL) : Mobility
categories
measurements
group Id
OG000
value
70
group Id
OG001
value
6
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
76
group Id
OG001
value
76
group Id
OG002
value
76
units
Participants
title
Baseline (BL) : Self-care
categories
measurements
group Id
OG000
value
53
group Id
OG001
value
22
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
76
group Id
OG001
value
76
group Id
OG002
value
76
units
Participants
title
Baseline (BL) : Usual Activities
categories
measurements
group Id
OG000
value
45
group Id
OG001
value
29
group Id
OG002
value
2
denoms
counts
group Id
OG000
value
76
group Id
OG001
value
76
group Id
OG002
value
76
units
Participants
title
Baseline (BL) : Pain/Discomfort
categories
measurements
group Id
OG000
value
52
group Id
OG001
value
21
group Id
OG002
value
3
denoms
counts
group Id
OG000
value
76
group Id
OG001
value
76
group Id
OG002
value
76
units
Participants
title
Baseline (BL) : Anxiety/Depression
categories
measurements
group Id
OG000
value
52
group Id
OG001
value
12
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
64
group Id
OG001
value
64
group Id
OG002
value
64
units
Participants
title
Month 3 : Mobility
categories
measurements
group Id
OG000
value
62
group Id
OG001
value
2
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
64
group Id
OG001
value
64
group Id
OG002
value
64
units
Participants
title
Month 3: Self-care
categories
measurements
group Id
OG000
value
48
group Id
OG001
value
16
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
64
group Id
OG001
value
64
group Id
OG002
value
64
units
Participants
title
Month 3: Usual Activities
categories
measurements
group Id
OG000
value
35
group Id
OG001
value
26
group Id
OG002
value
3
denoms
counts
group Id
OG000
value
64
group Id
OG001
value
64
group Id
OG002
value
64
units
Participants
title
Month 3: Pain/Discomfort
categories
measurements
group Id
OG000
value
52
group Id
OG001
value
11
group Id
OG002
value
1
denoms
counts
group Id
OG000
value
64
group Id
OG001
value
64
group Id
OG002
value
64
units
Participants
title
Month 3: Anxiety/Depression
categories
measurements
group Id
OG000
value
55
group Id
OG001
value
9
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
64
group Id
OG001
value
64
group Id
OG002
value
64
units
Participants
title
Month 6: Mobility
categories
measurements
group Id
OG000
value
61
group Id
OG001
value
3
group Id
OG002
value
0
denoms
counts
group Id
OG000
value
64
group Id
OG001
value
64
group Id
OG002
value
64
units
Participants
title
Month 6: Self-care

denoms

counts
group Id
OG000
value
76
group Id
OG001
value
76
group Id
OG002
value
76
units
Participants

description

Effect of tisagenlecleucel therapy on patient-reported outcomes was assessed using the EuroQol 5-Dimension, 3-Level instrument (EQ-5D-3L). The EQ-5D-3L is a widely used, self-administered questionnaire designed to evaluate health status in adults. It consists of two sections. The first includes one item for each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Patients rate each dimension as "no problems" (level 1), "some problems" (level 2), or "extreme problems" (level 3). This record summarizes, for each of the five dimensions, the number of patients falling into each response level.

groups

description
Participants who had no problems
id
OG000
title
CTL019: EQ 5D 3L Dimensions by Visit - Level 1
description
Participants who had some problems
id
OG001
title
CTL019: EQ 5D 3L Dimensions by Visit - Level 2
description
Participants who had severe problems
id
OG002
title
CTL019: EQ 5D 3L Dimensions by Visit -Level 3

param Type

COUNT_OF_PARTICIPANTS

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 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 36

title

Health Status Measured by EQ-5D-3L Questionnaire

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice