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NCT02435849 · OUTCOME

Effects of CTL019 Therapy on Patient Reported Outcomes as Measured by EQ-5D Questionnaire

Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients · Source last updated 2024-02-13

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Month 60

What was measured

Results from the EQ-5D questionnaire is for number of participants who achieved CR or CRi at month 60. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain \& discomfort, anxiety \& depression. Respondents are asked to choose the statement in each dimension that best describes their health status on the day surveyed. Their responses are coded as a number (1, 2, or 3) that corresponds to the respective level of severity: 1 indicates no problems, 2 some problems, and 3 severe problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The scores are then normalized to a value from 0-100 where higher scores = better HRQOL \& fewer problems or symptoms.

Analysis population: FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel and who had evaluable results at the measured time points. This analysis included a subset of FAS who had any data of the particular questionnaire at the measured timepoints. Therefore, no participants in Cohort 1 had questionnaire data for tisagenlecleucel at the measured time points, so no data was collected for Cohort 1.

Groups in this outcome

Main Cohort: Single Dose of CTL019

Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).

Cohort 1: Single Dose of CTL019

Pediatric B-ALL patients who are very high risk at first relapse.

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

Analysis denominator · Participants

GroupSource count
Main Cohort: Single Dose of CTL01916
Cohort 1: Single Dose of CTL0190

Reported measurements

M60: Mobility - No problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01915Not reportedNot reportedNot reportedNot reported
M60: Mobility - Some problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0191Not reportedNot reportedNot reportedNot reported
M60: Mobility - Severe problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0190Not reportedNot reportedNot reportedNot reported
M60: Self-care - No problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01916Not reportedNot reportedNot reportedNot reported
M60: Self-care - Some problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0190Not reportedNot reportedNot reportedNot reported
M60: Self-care - Severe problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0190Not reportedNot reportedNot reportedNot reported
M60: Usual activities - No problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01915Not reportedNot reportedNot reportedNot reported
M60: Usual activities - Some problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0190Not reportedNot reportedNot reportedNot reported
M60: Usual activities - Severe problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0191Not reportedNot reportedNot reportedNot reported
M60: Pain/discomfort - No problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01914Not reportedNot reportedNot reportedNot reported
M60: Pain/discomfort - Some problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0192Not reportedNot reportedNot reportedNot reported
M60: Pain/discomfort - Severe problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0190Not reportedNot reportedNot reportedNot reported
M60: Anxiety/depression - No problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01912Not reportedNot reportedNot reportedNot reported
M60: Anxiety/depression - Some problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0194Not reportedNot reportedNot reportedNot reported
M60: Anxiety/depression - Severe problems
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL0190Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    M60: Mobility - No problems
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    M60: Mobility - Some problems
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    M60: Mobility - Severe problems
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    M60: Self-care - No problems
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    M60: Self-care - Some problems
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    M60: Self-care - Severe problems
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    M60: Usual activities - No problems
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    M60: Usual activities - Some problems
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    M60: Usual activities - Severe problems
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    M60: Pain/discomfort - No problems
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    M60: Pain/discomfort - Some problems
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    M60: Pain/discomfort - Severe problems
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Results from the EQ-5D questionnaire is for number of participants who achieved CR or CRi at month 60. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain \& discomfort, anxiety \& depression. Respondents are asked to choose the statement in each dimension that best describes their health status on the day surveyed. Their responses are coded as a number (1, 2, or 3) that corresponds to the respective level of severity: 1 indicates no problems, 2 some problems, and 3 severe problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The scores are then normalized to a value from 0-100 where higher scores = better HRQOL \& fewer problems or symptoms.
groups
  1. description
    Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).
    id
    OG000
    title
    Main Cohort: Single Dose of CTL019
  2. description
    Pediatric B-ALL patients who are very high risk at first relapse.
    id
    OG001
    title
    Cohort 1: Single Dose of CTL019
param Type
NUMBER
population Description
FAS: The Full analysis set comprised all patients who received infusion of tisagenlecleucel and who had evaluable results at the measured time points. This analysis included a subset of FAS who had any data of the particular questionnaire at the measured timepoints. Therefore, no participants in Cohort 1 had questionnaire data for tisagenlecleucel at the measured time points, so no data was collected for Cohort 1.
reporting Status
POSTED
time Frame
Month 60
title
Effects of CTL019 Therapy on Patient Reported Outcomes as Measured by EQ-5D Questionnaire
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice