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NCT03483103 · OUTCOME

Change From Baseline of Chemistry Laboratory Results: Calcium Corrected, Magnesium, Phosphate, Potassium, Sodium

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
MEAN
Unit
mmol/L
Interval / dispersion
Standard Deviation
Time frame
Baseline and Day 29

What was measured

Change from baseline in Chemistry laboratory analysis. Includes Calcium Corrected, Magnesium, Phosphate, Potassium, and Sodium. Baseline is the last observation collected prior to or on the date of product infusion.

Analysis population: All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests

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)59

Reported measurements

Calcium Corrected

Analysis denominator · Participants

GroupSource count
Lisocabtagene Maraleucel (JCAR017)59
Values in mmol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)-0.02610.12183Not reportedNot reportedNot reported
Magnesium

Analysis denominator · Participants

GroupSource count
Lisocabtagene Maraleucel (JCAR017)57
Values in mmol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)-0.02090.09292Not reportedNot reportedNot reported
Phosphate

Analysis denominator · Participants

GroupSource count
Lisocabtagene Maraleucel (JCAR017)58
Values in mmol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)0.04790.22624Not reportedNot reportedNot reported
Potassium

Analysis denominator · Participants

GroupSource count
Lisocabtagene Maraleucel (JCAR017)59
Values in mmol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)-0.050.426Not reportedNot reportedNot reported
Sodium

Analysis denominator · Participants

GroupSource count
Lisocabtagene Maraleucel (JCAR017)59
Values in mmol/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lisocabtagene Maraleucel (JCAR017)1.03.37Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.12183
        value
        -0.0261
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Calcium Corrected
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.09292
        value
        -0.0209
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      units
      Participants
    title
    Magnesium
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.22624
        value
        0.0479
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    Phosphate
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.426
        value
        -0.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Potassium
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.37
        value
        1.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Sodium
denoms
  1. counts
    1. group Id
      OG000
      value
      59
    units
    Participants
description
Change from baseline in Chemistry laboratory analysis. Includes Calcium Corrected, Magnesium, Phosphate, Potassium, and Sodium. Baseline is the last observation collected prior to or on the date of product infusion.
dispersion Type
Standard Deviation
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
MEAN
population Description
All participants who received at least one JCAR017 infusion evaluable for chemistry laboratory tests
reporting Status
POSTED
time Frame
Baseline and Day 29
title
Change From Baseline of Chemistry Laboratory Results: Calcium Corrected, Magnesium, Phosphate, Potassium, Sodium
type
SECONDARY
unit Of Measure
mmol/L

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

Preserved source evidence · Not medical advice