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NCT05386550 · OUTCOME

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score

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

The EORTC QLQ-HN35 is designed to be used together with the core QLQ-C30. The recall period for the items in the module was "the past week". Items hn1 to hn30 were scored on 4 point Likert type categorical scales ("not at all", "a little", "quite a bit", "very much").Items hn31 to hn35 had a "no/yes" response format. The scores were transformed into 0 to 100 scales, with a high score implying a high level of symptoms. Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales.

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 +IMRT52
Placebo +IMRT56

Reported measurements

Pain at Day 64

Analysis denominator · Participants

GroupSource count
Xevinapant +IMRT52
Placebo +IMRT56
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Xevinapant +IMRT9.4Not reported1.417.4Not reported
Placebo +IMRT6.0Not reported-1.513.6Not reported
Pain at Day 134

Analysis denominator · Participants

GroupSource count
Xevinapant +IMRT30
Placebo +IMRT37
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Xevinapant +IMRT-1.1Not reported-8.66.5Not reported
Placebo +IMRT-1.2Not reported-8.05.7Not reported
Speech at Day 64

Analysis denominator · Participants

GroupSource count
Xevinapant +IMRT51
Placebo +IMRT56
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Xevinapant +IMRT2.9Not reported-5.311.1Not reported
Placebo +IMRT-3.0Not reported-10.74.7Not reported
Speech at Day 134

Analysis denominator · Participants

GroupSource count
Xevinapant +IMRT30
Placebo +IMRT37
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Xevinapant +IMRT-2.8Not reported-10.95.3Not reported
Placebo +IMRT-3.8Not reported-11.23.6Not reported
Swallowing at Day 64

Analysis denominator · Participants

GroupSource count
Xevinapant +IMRT52
Placebo +IMRT56
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Xevinapant +IMRT7.6Not reported-0.916.1Not reported
Placebo +IMRT3.4Not reported-4.611.4Not reported
Swallowing at Day 134

Analysis denominator · Participants

GroupSource count
Xevinapant +IMRT30
Placebo +IMRT37
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Xevinapant +IMRT-4.5Not reported-12.43.4Not reported
Placebo +IMRT-1.6Not reported-8.75.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        17.4
        value
        9.4
      2. group Id
        OG001
        lower Limit
        -1.5
        upper Limit
        13.6
        value
        6.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        56
      units
      Participants
    title
    Pain at Day 64
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -8.6
        upper Limit
        6.5
        value
        -1.1
      2. group Id
        OG001
        lower Limit
        -8.0
        upper Limit
        5.7
        value
        -1.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    Pain at Day 134
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.3
        upper Limit
        11.1
        value
        2.9
      2. group Id
        OG001
        lower Limit
        -10.7
        upper Limit
        4.7
        value
        -3.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        56
      units
      Participants
    title
    Speech at Day 64
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -10.9
        upper Limit
        5.3
        value
        -2.8
      2. group Id
        OG001
        lower Limit
        -11.2
        upper Limit
        3.6
        value
        -3.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    Speech at Day 134
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.9
        upper Limit
        16.1
        value
        7.6
      2. group Id
        OG001
        lower Limit
        -4.6
        upper Limit
        11.4
        value
        3.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        56
      units
      Participants
    title
    Swallowing at Day 64
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -12.4
        upper Limit
        3.4
        value
        -4.5
      2. group Id
        OG001
        lower Limit
        -8.7
        upper Limit
        5.5
        value
        -1.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    Swallowing at Day 134
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    2. group Id
      OG001
      value
      56
    units
    Participants
description
The EORTC QLQ-HN35 is designed to be used together with the core QLQ-C30. The recall period for the items in the module was "the past week". Items hn1 to hn30 were scored on 4 point Likert type categorical scales ("not at all", "a little", "quite a bit", "very much").Items hn31 to hn35 had a "no/yes" response format. The scores were transformed into 0 to 100 scales, with a high score implying a high level of symptoms. Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales.
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 European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN35) Score
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice