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NCT03568461 · OUTCOME

Summary Scores of PRO Measured by EQ-VAS 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

Effect of tisagenlecleucel therapy on patient reported outcomes were reported using the EQ-VAS (EuroQol Visual Analogue Scale). The EQ-VAS is a 20 cm vertical, 0-100 numerical scale used alongside the EQ-5D questionnaire to measure a patient's self-rated health. It anchors "best imaginable health" (100) at the top and "worst imaginable health" (0) at the bottom, providing a quick, subjective, quantitative, and global assessment of health status on the day of survey

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

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: Physical Health Total Score76

Reported measurements

Baseline (BL)

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score76
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score69.420.97Not reportedNot reportedNot reported
M3 Change from BL (CFB)

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score60
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score3.423.70Not reportedNot reportedNot reported
M6 CFB

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score58
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score3.718.63Not reportedNot reportedNot reported
M9 CFB

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score39
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score6.114.72Not reportedNot reportedNot reported
M12 CFB

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score44
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score5.813.55Not reportedNot reportedNot reported
M18 CFB

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score43
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score6.812.64Not reportedNot reportedNot reported
M24 CFB

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score40
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score3.517.33Not reportedNot reportedNot reported
M36 CFB

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score18
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score4.416.81Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.97
        value
        69.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      units
      Participants
    title
    Baseline (BL)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.70
        value
        3.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        60
      units
      Participants
    title
    M3 Change from BL (CFB)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.63
        value
        3.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    M6 CFB
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.72
        value
        6.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      units
      Participants
    title
    M9 CFB
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.55
        value
        5.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        44
      units
      Participants
    title
    M12 CFB
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.64
        value
        6.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      units
      Participants
    title
    M18 CFB
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.33
        value
        3.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      units
      Participants
    title
    M24 CFB
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.81
        value
        4.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      units
      Participants
    title
    M36 CFB
denoms
  1. counts
    1. group Id
      OG000
      value
      76
    units
    Participants
description
Effect of tisagenlecleucel therapy on patient reported outcomes were reported using the EQ-VAS (EuroQol Visual Analogue Scale). The EQ-VAS is a 20 cm vertical, 0-100 numerical scale used alongside the EQ-5D questionnaire to measure a patient's self-rated health. It anchors "best imaginable health" (100) at the top and "worst imaginable health" (0) at the bottom, providing a quick, subjective, quantitative, and global assessment of health status on the day of survey
dispersion Type
Standard Deviation
groups
  1. description
    All participants who were enrolled in the study
    id
    OG000
    title
    CTL019: Physical 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
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 EQ-VAS Quality of Life Questionnaire Reported by Change From Baseline
type
SECONDARY
unit Of Measure
scores on a scale

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

Preserved source evidence · Not medical advice