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NCT03484702 · OUTCOME

Number of Participants With Adverse Events in Cohort 7

Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma · Source last updated 2024-12-27

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From leukapheresis to end of study (up to approximately 63 months)

What was measured

An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

Analysis population: All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only

Groups in this outcome

Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting

JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).

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

Analysis denominator · Participants

GroupSource count
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9

Reported measurements

AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting0Not reportedNot reportedNot reportedNot reported
AEs occurring between LDC and JCAR017 infusion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting2Not reportedNot reportedNot reportedNot reported
AEs occurring between JCAR017 infusion and Day 30
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting9Not reportedNot reportedNot reportedNot reported
AEs occurring between Day 31 and Day 90
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting7Not reportedNot reportedNot reportedNot reported
AEs occurring between Day 91 and end of study
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    AEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    AEs occurring between LDC and JCAR017 infusion
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    AEs occurring between JCAR017 infusion and Day 30
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    AEs occurring between Day 31 and Day 90
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    AEs occurring between Day 91 and end of study
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.
groups
  1. description
    JCAR017 was infused at a dose of 100 x 10\^6 JCAR017-positive transfected viable T cells (50 × 10\^6 CD8+ CAR+ T cells and 50 × 10\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).
    id
    OG000
    title
    Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only
reporting Status
POSTED
time Frame
From leukapheresis to end of study (up to approximately 63 months)
title
Number of Participants With Adverse Events in Cohort 7
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice