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NCT03589469 · OUTCOME

Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment

Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma · Source last updated 2023-08-29

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
Baseline and end of treatment (up to 599 days)

What was measured

ECOG (Eastern Cooperative Oncology Group) Performance Status is scored on a 6-point scale where higher scores indicate a worse outcome. ECOG scores include the following: * 0 = fully active, able to carry on all pre-disease performance without restriction * 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work * 2 = ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours * 3 = capable of only limited self-care; confined to bed or chair more than 50% of waking hours * 4 = completely disabled; cannot carry on any self-care; totally confined to bed or chair * 5 = dead

Analysis population: All-treated population - all participants who received at least 1 dose of treatment. Results are presented for participants with data available for analysis at end of treatment.

Groups in this outcome

Loncastuximab Tesirine

Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine145

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine145

ECOG score 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine58Not reportedNot reportedNot reportedNot reported

ECOG score 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine78Not reportedNot reportedNot reportedNot reported

ECOG score 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine9Not reportedNot reportedNot reportedNot reported

ECOG score 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine0Not reportedNot reportedNot reportedNot reported

ECOG score 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine0Not reportedNot reportedNot reportedNot reported

ECOG score 5

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine0Not reportedNot reportedNot reportedNot reported
End of treatment

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine111

ECOG score 0

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine44Not reportedNot reportedNot reportedNot reported

ECOG score 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine50Not reportedNot reportedNot reportedNot reported

ECOG score 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine14Not reportedNot reportedNot reportedNot reported

ECOG score 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine2Not reportedNot reportedNot reportedNot reported

ECOG score 4

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine1Not reportedNot reportedNot reportedNot reported

ECOG score 5

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        58
      title
      ECOG score 0
    2. measurements
      1. group Id
        OG000
        value
        78
      title
      ECOG score 1
    3. measurements
      1. group Id
        OG000
        value
        9
      title
      ECOG score 2
    4. measurements
      1. group Id
        OG000
        value
        0
      title
      ECOG score 3
    5. measurements
      1. group Id
        OG000
        value
        0
      title
      ECOG score 4
    6. measurements
      1. group Id
        OG000
        value
        0
      title
      ECOG score 5
    denoms
    1. counts
      1. group Id
        OG000
        value
        145
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        44
      title
      ECOG score 0
    2. measurements
      1. group Id
        OG000
        value
        50
      title
      ECOG score 1
    3. measurements
      1. group Id
        OG000
        value
        14
      title
      ECOG score 2
    4. measurements
      1. group Id
        OG000
        value
        2
      title
      ECOG score 3
    5. measurements
      1. group Id
        OG000
        value
        1
      title
      ECOG score 4
    6. measurements
      1. group Id
        OG000
        value
        0
      title
      ECOG score 5
    denoms
    1. counts
      1. group Id
        OG000
        value
        111
      units
      Participants
    title
    End of treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      145
    units
    Participants
description
ECOG (Eastern Cooperative Oncology Group) Performance Status is scored on a 6-point scale where higher scores indicate a worse outcome. ECOG scores include the following: * 0 = fully active, able to carry on all pre-disease performance without restriction * 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work * 2 = ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours * 3 = capable of only limited self-care; confined to bed or chair more than 50% of waking hours * 4 = completely disabled; cannot carry on any self-care; totally confined to bed or chair * 5 = dead
groups
  1. description
    Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
    id
    OG000
    title
    Loncastuximab Tesirine
param Type
COUNT_OF_PARTICIPANTS
population Description
All-treated population - all participants who received at least 1 dose of treatment. Results are presented for participants with data available for analysis at end of treatment.
reporting Status
POSTED
time Frame
Baseline and end of treatment (up to 599 days)
title
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice