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NCT03568461 · OUTCOME

Summary Scores of PRO Measured by EQ-VAS Quality of Life Questionnaire by Visit

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

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. The second section of the questionnaire measures self-rated (global) health status utilizing a vertically oriented visual analogue scale where 100 represents the "best possible health state" and 0 represents the "worst possible 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

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
Month (M) 3

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score64
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score75.520.41Not reportedNot reportedNot reported
M6

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score63
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score72.519.77Not reportedNot reportedNot reported
M9

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 Score76.414.30Not reportedNot reportedNot reported
M12

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score50
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score75.919.15Not reportedNot reportedNot reported
M18

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score49
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score76.518.01Not reportedNot reportedNot reported
M24

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score47
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score73.019.70Not reportedNot reportedNot reported
M36

Analysis denominator · Participants

GroupSource count
CTL019: Physical Health Total Score21
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CTL019: Physical Health Total Score73.520.47Not 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
        20.41
        value
        75.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      units
      Participants
    title
    Month (M) 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.77
        value
        72.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      units
      Participants
    title
    M6
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.30
        value
        76.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      units
      Participants
    title
    M9
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.15
        value
        75.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    M12
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.01
        value
        76.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      units
      Participants
    title
    M18
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.70
        value
        73.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      units
      Participants
    title
    M24
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.47
        value
        73.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      units
      Participants
    title
    M36
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. The second section of the questionnaire measures self-rated (global) health status utilizing a vertically oriented visual analogue scale where 100 represents the "best possible health state" and 0 represents the "worst possible health state."
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) Month (M) 3, M6, M9, M12, M18, M24, M36
title
Summary Scores of PRO Measured by EQ-VAS Quality of Life Questionnaire by Visit
type
SECONDARY
unit Of Measure
scores on a scale

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

Preserved source evidence · Not medical advice