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NCT02614066 · OUTCOME

Phase 2: EQ-5D Visual Analogue Scale (VAS) Score

A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3) · Source last updated 2024-11-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Day 28, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, and Month 24

What was measured

EQ-5D is a self-reported questionnaire used for assessing the overall health status of a participant. The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The EQ-5D-VAS records the participant's self-rated health on a 20-cm vertical visual analogue scale and is asked to make a global assessment of their current state of health with 0 indicating the worst health they can imagine and 100 indicating the best health they can imagine. Higher scores indicated a better health state.

Analysis population: Participants in Safety Analysis Set with available data were analyzed.

Groups in this outcome

Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg

Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg51

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg51
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg68.221.8Not reportedNot reportedNot reported
Day 28

Analysis denominator · Participants

GroupSource count
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg41
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg74.717.9Not reportedNot reportedNot reported
Month 3

Analysis denominator · Participants

GroupSource count
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg26
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg79.712.2Not reportedNot reportedNot reported
Month 6

Analysis denominator · Participants

GroupSource count
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg25
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg81.017.6Not reportedNot reportedNot reported
Month 9

Analysis denominator · Participants

GroupSource count
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg10
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg81.723.1Not reportedNot reportedNot reported
Month 12

Analysis denominator · Participants

GroupSource count
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg14
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg86.910.0Not reportedNot reportedNot reported
Month 15

Analysis denominator · Participants

GroupSource count
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg10
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg87.811.6Not reportedNot reportedNot reported
Month 18

Analysis denominator · Participants

GroupSource count
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg4
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg93.35.9Not reportedNot reportedNot reported
Month 24

Analysis denominator · Participants

GroupSource count
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg4
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg97.52.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.8
        value
        68.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.9
        value
        74.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      units
      Participants
    title
    Day 28
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.2
        value
        79.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Month 3
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.6
        value
        81.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    Month 6
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.1
        value
        81.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Month 9
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.0
        value
        86.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Month 12
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.6
        value
        87.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Month 15
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.9
        value
        93.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Month 18
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.9
        value
        97.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Month 24
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    units
    Participants
description
EQ-5D is a self-reported questionnaire used for assessing the overall health status of a participant. The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The EQ-5D-VAS records the participant's self-rated health on a 20-cm vertical visual analogue scale and is asked to make a global assessment of their current state of health with 0 indicating the worst health they can imagine and 100 indicating the best health they can imagine. Higher scores indicated a better health state.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
    id
    OG000
    title
    Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg
param Type
MEAN
population Description
Participants in Safety Analysis Set with available data were analyzed.
reporting Status
POSTED
time Frame
Baseline, Day 28, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, and Month 24
title
Phase 2: EQ-5D Visual Analogue Scale (VAS) Score
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice