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NCT04101331 · OUTCOME

European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D)

Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides · Source last updated 2024-11-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
From baseline until final study visit, up to 199 weeks.

What was measured

Quality of Life (QoL) as measured by the European Quality of Life 5-dimensional questionnaire (EQ-5D) for Cohorts A. Visual Analogue Scale scores assessed based on drawn scale from 0(worst imaginable state) to 100(best imaginable state). Subjects chose their health state on scale based on their situation by themselves. A negative outcome indicates a decrease in score compared to the baseline value.

Analysis population: The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.

Groups in this outcome

Cohort A

Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).

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 A108

Reported measurements

Source class 1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort A-9.1625.46Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.46
        value
        -9.16
denoms
  1. counts
    1. group Id
      OG000
      value
      108
    units
    Participants
description
Quality of Life (QoL) as measured by the European Quality of Life 5-dimensional questionnaire (EQ-5D) for Cohorts A. Visual Analogue Scale scores assessed based on drawn scale from 0(worst imaginable state) to 100(best imaginable state). Subjects chose their health state on scale based on their situation by themselves. A negative outcome indicates a decrease in score compared to the baseline value.
dispersion Type
Standard Deviation
groups
  1. description
    Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
    id
    OG000
    title
    Cohort A
param Type
MEAN
population Description
The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
reporting Status
POSTED
time Frame
From baseline until final study visit, up to 199 weeks.
title
European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D)
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice