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NCT03483103 · OUTCOME

Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006) · Source last updated 2023-12-20

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 first dose to 90 days following first dose (up to approximately 90 days)

What was measured

A TEAE was defined as an adverse event that started any time from initiation of product administration through and including 90 days following product administration. AEs that occurred after the initiation of subsequent anticancer therapy or product retreatment were not considered as product TEAE. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe, Grade 4= Life-threatening, and 5 = Death.

Analysis population: All participants who received at least one JCAR017 infusion

Groups in this outcome

Lisocabtagene Maraleucel (JCAR017)

Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 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
Lisocabtagene Maraleucel (JCAR017)61

Reported measurements

Participants with any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)59Not reportedNot reportedNot reportedNot reported
Participants with any serious TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)20Not reportedNot reportedNot reportedNot reported
Participants with any Grade ≥ 3 TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)48Not reportedNot reportedNot reportedNot reported
Participants with any product-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)48Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        59
    title
    Participants with any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    Participants with any serious TEAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        48
    title
    Participants with any Grade ≥ 3 TEAEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        48
    title
    Participants with any product-related TEAE
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    units
    Participants
description
A TEAE was defined as an adverse event that started any time from initiation of product administration through and including 90 days following product administration. AEs that occurred after the initiation of subsequent anticancer therapy or product retreatment were not considered as product TEAE. AEs are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.03) (NCI CTCAE) guidelines where Grade 3= Severe, Grade 4= Life-threatening, and 5 = Death.
groups
  1. description
    Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
    id
    OG000
    title
    Lisocabtagene Maraleucel (JCAR017)
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received at least one JCAR017 infusion
reporting Status
POSTED
time Frame
From first dose to 90 days following first dose (up to approximately 90 days)
title
Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice