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NCT05386550 · OUTCOME

Change From Baseline in EuroQOL 5 Dimension 5 Level Health-Related Quality of Life Measure Visual Analog Scale Score (EQ-5D-5L VAS)

Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION) · Source last updated 2026-02-19

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

Measure
LEAST_SQUARES_MEAN
Unit
score on a scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, Day 64 and End of treatment (Day 134)

What was measured

EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100, where 0 is the worst health you can imagine and 100 is the best health you can imagine.

Analysis population: FAS included all participants who were randomized to study treatment. Here,"Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific categories.

Groups in this outcome

Xevinapant +IMRT

Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

Placebo +IMRT

Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle in combination with with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).

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

Analysis denominator · Participants

GroupSource count
Xevinapant +IMRT50
Placebo +IMRT57

Reported measurements

At Day 64

Analysis denominator · Participants

GroupSource count
Xevinapant +IMRT50
Placebo +IMRT57
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Xevinapant +IMRT-1.8Not reported-8.14.5Not reported
Placebo +IMRT1.1Not reported-4.76.9Not reported
At Day 134

Analysis denominator · Participants

GroupSource count
Xevinapant +IMRT31
Placebo +IMRT38
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Xevinapant +IMRT1.1Not reported-5.17.3Not reported
Placebo +IMRT2.4Not reported-3.38.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -8.1
        upper Limit
        4.5
        value
        -1.8
      2. group Id
        OG001
        lower Limit
        -4.7
        upper Limit
        6.9
        value
        1.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        57
      units
      Participants
    title
    At Day 64
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.1
        upper Limit
        7.3
        value
        1.1
      2. group Id
        OG001
        lower Limit
        -3.3
        upper Limit
        8.0
        value
        2.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        38
      units
      Participants
    title
    At Day 134
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      57
    units
    Participants
description
EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100, where 0 is the worst health you can imagine and 100 is the best health you can imagine.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
    id
    OG000
    title
    Xevinapant +IMRT
  2. description
    Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle in combination with with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
    id
    OG001
    title
    Placebo +IMRT
param Type
LEAST_SQUARES_MEAN
population Description
FAS included all participants who were randomized to study treatment. Here,"Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "number analysed" signifies participants at the specific categories.
reporting Status
POSTED
time Frame
Baseline, Day 64 and End of treatment (Day 134)
title
Change From Baseline in EuroQOL 5 Dimension 5 Level Health-Related Quality of Life Measure Visual Analog Scale Score (EQ-5D-5L VAS)
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice