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NCT02445248 · OUTCOME

Overall Survival (OS) Per Independent Review Committee

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
60 months

What was measured

OS is the time from date of CTL019 infusion to the date of death due to any cause.

Analysis population: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.

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.

Tisagenlecleucel - Cohort A

Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.

Tisagenlecleucel - All Patients

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 and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.

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 Cohort99
Tisagenlecleucel - Cohort A16
Tisagenlecleucel - All Patients115

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - Main Cohort12.5Not reported7.234.2Not reported
Tisagenlecleucel - Cohort A5.9Not reported3.119.2Not reported
Tisagenlecleucel - All Patients11.1Not reported6.623.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.2
        upper Limit
        34.2
        value
        12.5
      2. group Id
        OG001
        lower Limit
        3.1
        upper Limit
        19.2
        value
        5.9
      3. group Id
        OG002
        lower Limit
        6.6
        upper Limit
        23.9
        value
        11.1
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      115
    units
    Participants
description
OS is the time from date of CTL019 infusion to the date of death due to any cause.
dispersion Type
95% Confidence Interval
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
  2. description
    Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
    id
    OG001
    title
    Tisagenlecleucel - Cohort A
  3. 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 and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
    id
    OG002
    title
    Tisagenlecleucel - All Patients
param Type
MEDIAN
population Description
Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.
reporting Status
POSTED
time Frame
60 months
title
Overall Survival (OS) Per Independent Review Committee
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice