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NCT02435849 · OUTCOME

All Collected Deaths

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
On-treatment deaths: Up to 60 months; Post-treatment survival follow-up deaths: Up to approx. 60 months

What was measured

On-treatment deaths, which include post-treatment survival follow-up deaths, were collected during the post-infusion period (starting at the day of first infusion) until the end of the study, approx. 60 months. All deaths refers to the sum of on-treatment deaths and post-treatment survival follow-up deaths up to approx. 60 months.

Analysis population: Clinical Database Population: all infused participants in the Main cohort

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 CTL01979
Cohort 1: Single Dose of CTL0191

Reported measurements

On-treatment deaths include post-treatment survival follow-up deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01933Not reportedNot reportedNot reportedNot reported
Cohort 1: Single Dose of CTL0190Not reportedNot reportedNot reportedNot reported
All deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Cohort: Single Dose of CTL01933Not reportedNot reportedNot reportedNot reported
Cohort 1: Single Dose of CTL0190Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        0
    title
    On-treatment deaths include post-treatment survival follow-up deaths
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        0
    title
    All deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      1
    units
    Participants
description
On-treatment deaths, which include post-treatment survival follow-up deaths, were collected during the post-infusion period (starting at the day of first infusion) until the end of the study, approx. 60 months. All deaths refers to the sum of on-treatment deaths and post-treatment survival follow-up deaths up to approx. 60 months.
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
Clinical Database Population: all infused participants in the Main cohort
reporting Status
POSTED
time Frame
On-treatment deaths: Up to 60 months; Post-treatment survival follow-up deaths: Up to approx. 60 months
title
All Collected Deaths
type
POST_HOC
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice