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NCT05347485 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity

A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma · Source last updated 2025-04-25

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 Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)

What was measured

An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily had a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as any AE that occurs on or after the start of cilta-cel OOS infusion through 100 days after the cilta-cel OOS infusion or the start of subsequent anti-myeloma therapy, whichever was earlier; or any AE that is considered related to study intervention regardless of the start date of the event; or any AE that was present at baseline (Day 1, pre-infusion of cilta-cel OOS) but worsens in toxicity grade or was subsequently considered related to study intervention by the investigator. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 as: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to adverse event.

Analysis population: The all treated analysis set included all participants who received study intervention (cilta-cel OOS).

Groups in this outcome

Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)

Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\*10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.

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

Analysis denominator · Participants

GroupSource count
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)82

Reported measurements

Grade 1: Mild
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)1Not reportedNot reportedNot reportedNot reported
Grade 2: Moderate
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)6Not reportedNot reportedNot reportedNot reported
Grade 3: Severe
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)14Not reportedNot reportedNot reportedNot reported
Grade 4: Life-threatening
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)51Not reportedNot reportedNot reportedNot reported
Grade 5: Death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 1: Mild
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Grade 2: Moderate
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Grade 3: Severe
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        51
    title
    Grade 4: Life-threatening
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Grade 5: Death
denoms
  1. counts
    1. group Id
      OG000
      value
      82
    units
    Participants
description
An AE was any untoward medical occurrence in a participant participating in a clinical study that did not necessarily had a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as any AE that occurs on or after the start of cilta-cel OOS infusion through 100 days after the cilta-cel OOS infusion or the start of subsequent anti-myeloma therapy, whichever was earlier; or any AE that is considered related to study intervention regardless of the start date of the event; or any AE that was present at baseline (Day 1, pre-infusion of cilta-cel OOS) but worsens in toxicity grade or was subsequently considered related to study intervention by the investigator. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 as: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to adverse event.
groups
  1. description
    Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\*10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.
    id
    OG000
    title
    Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)
param Type
COUNT_OF_PARTICIPANTS
population Description
The all treated analysis set included all participants who received study intervention (cilta-cel OOS).
reporting Status
POSTED
time Frame
From Day 1 up to 100 days post cilta-cel OOS infusion (Up to 100 days)
title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice