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NCT04101331 · OUTCOME

European Quality of Life 5-dimensional Pain/Discomfort Score (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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At baseline and final study visit, up to 199 weeks.

What was measured

Quality of Life (QoL) as measured by the European QoL 5-dimensional questionnaire (EQ-5D) for Cohorts A. The EQ-5D comprises asks for the current health state in the five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Pain/discomfort scores assessed based on questionnaire. The categories of the response offer three levels pain/discomfort score: "no pain or discomfort" (score of 1), "moderate pain or discomfort" (score of 2), and "extreme pain and discomfort" (score of 3). Scores are presented from baseline to each visit for Cohort A.

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

Baseline

No pain or discomfort

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A41Not reportedNot reportedNot reportedNot reported

Moderate pain or discomfort

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A55Not reportedNot reportedNot reportedNot reported

Extreme pain or discomfort

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A9Not reportedNot reportedNot reportedNot reported

Missing

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A3Not reportedNot reportedNot reportedNot reported
Final Study Visit

No pain or discomfort

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A19Not reportedNot reportedNot reportedNot reported

Moderate pain or discomfort

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A38Not reportedNot reportedNot reportedNot reported

Extreme pain or discomfort

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A5Not reportedNot reportedNot reportedNot reported

Missing

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A46Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        41
      title
      No pain or discomfort
    2. measurements
      1. group Id
        OG000
        value
        55
      title
      Moderate pain or discomfort
    3. measurements
      1. group Id
        OG000
        value
        9
      title
      Extreme pain or discomfort
    4. measurements
      1. group Id
        OG000
        value
        3
      title
      Missing
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      title
      No pain or discomfort
    2. measurements
      1. group Id
        OG000
        value
        38
      title
      Moderate pain or discomfort
    3. measurements
      1. group Id
        OG000
        value
        5
      title
      Extreme pain or discomfort
    4. measurements
      1. group Id
        OG000
        value
        46
      title
      Missing
    title
    Final Study Visit
denoms
  1. counts
    1. group Id
      OG000
      value
      108
    units
    Participants
description
Quality of Life (QoL) as measured by the European QoL 5-dimensional questionnaire (EQ-5D) for Cohorts A. The EQ-5D comprises asks for the current health state in the five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Pain/discomfort scores assessed based on questionnaire. The categories of the response offer three levels pain/discomfort score: "no pain or discomfort" (score of 1), "moderate pain or discomfort" (score of 2), and "extreme pain and discomfort" (score of 3). Scores are presented from baseline to each visit for Cohort A.
groups
  1. description
    Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
    id
    OG000
    title
    Cohort A
param Type
COUNT_OF_PARTICIPANTS
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
At baseline and final study visit, up to 199 weeks.
title
European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice