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NCT03484702 · OUTCOME

Number of Participants With Serious Adverse Events (SAEs) 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

A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. 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

SAEs 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
SAEs 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 Setting0Not reportedNot reportedNot reportedNot reported
SAEs 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 Setting1Not reportedNot reportedNot reportedNot reported
SAEs 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 Setting0Not reportedNot reportedNot reportedNot reported
SAEs 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 Setting1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    SAEs occurring between LDC and JCAR017 infusion
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    SAEs occurring between JCAR017 infusion and Day 30
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    SAEs occurring between Day 31 and Day 90
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    SAEs occurring between Day 91 and end of study
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. 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 Serious Adverse Events (SAEs) in Cohort 7
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice