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NCT02445248 · OUTCOME

All Collected Deaths

Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients · Source last updated 2024-04-18

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 61 months; Post-treatment survival follow-up deaths: Up to approx. 61 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. 61 months. All deaths refers to the sum of on-treatment deaths and post-treatment survival follow-up deaths up to approx. 61 months.

Analysis population: Clinical Database Population: all infused participants in the Study.

Groups in this outcome

Tisagenlecleucel - Main Cohort

Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.

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

Analysis denominator · Participants

GroupSource count
Tisagenlecleucel - Main Cohort115

Reported measurements

On-treatment deaths include post-treatment survival follow-up deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - Main Cohort76Not reportedNot reportedNot reportedNot reported
All deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - Main Cohort76Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        76
    title
    On-treatment deaths include post-treatment survival follow-up deaths
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        76
    title
    All deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      115
    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. 61 months. All deaths refers to the sum of on-treatment deaths and post-treatment survival follow-up deaths up to approx. 61 months.
groups
  1. description
    Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
    id
    OG000
    title
    Tisagenlecleucel - Main Cohort
param Type
NUMBER
population Description
Clinical Database Population: all infused participants in the Study.
reporting Status
POSTED
time Frame
On-treatment deaths: Up to 61 months; Post-treatment survival follow-up deaths: Up to approx. 61 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