NCT05386550 · OUTCOME
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) 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
EORTC QLQ-C30 is a 30 item questionnaire composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, and social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health/quality of life (QOL) subscale, and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation, and the financial impact of cancer). The questionnaire employed twenty-eight 4 point Likert scales with responses from "not at all" to "very much" and two 7 point Likert scales for global health and overall QOL. For functional and global QOL scales, higher scores represented a better level of functioning and all scores were converted to a 0 to 100 scale. For symptom oriented scales, a higher score represented more severe symptoms, and all scores were converted to a 0-100 scale. 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
| Group | Source count |
|---|
| Xevinapant +IMRT | 54 |
|---|
| Placebo +IMRT | 58 |
|---|
Reported measurements
Fatigue at Day 64
Analysis denominator · Participants
| Group | Source count |
|---|
| Xevinapant +IMRT | 54 |
|---|
| Placebo +IMRT | 58 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Xevinapant +IMRT | 4.9 | Not reported | -2.4 | 12.3 | Not reported |
|---|
| Placebo +IMRT | 0.7 | Not reported | -6.2 | 7.5 | Not reported |
|---|
Fatigue at Day 134
Analysis denominator · Participants
| Group | Source count |
|---|
| Xevinapant +IMRT | 30 |
|---|
| Placebo +IMRT | 37 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Xevinapant +IMRT | 5.2 | Not reported | -3.7 | 14.1 | Not reported |
|---|
| Placebo +IMRT | -0.6 | Not reported | -8.8 | 7.7 | Not reported |
|---|
Physical Functioning at Day 64
Analysis denominator · Participants
| Group | Source count |
|---|
| Xevinapant +IMRT | 54 |
|---|
| Placebo +IMRT | 58 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Xevinapant +IMRT | -3.4 | Not reported | -9.2 | 2.3 | Not reported |
|---|
| Placebo +IMRT | -0.2 | Not reported | -5.6 | 5.2 | Not reported |
|---|
Physical Functioning at Day 134
Analysis denominator · Participants
| Group | Source count |
|---|
| Xevinapant +IMRT | 30 |
|---|
| Placebo +IMRT | 37 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Xevinapant +IMRT | -3.5 | Not reported | -10.2 | 3.2 | Not reported |
|---|
| Placebo +IMRT | 0.2 | Not reported | -6.0 | 6.4 | Not reported |
|---|
Global Health Status at Day 64
Analysis denominator · Participants
| Group | Source count |
|---|
| Xevinapant +IMRT | 54 |
|---|
| Placebo +IMRT | 58 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Xevinapant +IMRT | 2.5 | Not reported | -4.0 | 9.0 | Not reported |
|---|
| Placebo +IMRT | 1.0 | Not reported | -5.0 | 7.1 | Not reported |
|---|
Global Health Status at Day 134
Analysis denominator · Participants
| Group | Source count |
|---|
| Xevinapant +IMRT | 30 |
|---|
| Placebo +IMRT | 37 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Xevinapant +IMRT | 0.9 | Not reported | -6.2 | 8.0 | Not reported |
|---|
| Placebo +IMRT | 3.1 | Not reported | -3.3 | 9.5 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.4
- upper Limit
- 12.3
- value
- 4.9
- group Id
- OG001
- lower Limit
- -6.2
- upper Limit
- 7.5
- value
- 0.7
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 58
- units
- Participants
- title
- Fatigue at Day 64
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.7
- upper Limit
- 14.1
- value
- 5.2
- group Id
- OG001
- lower Limit
- -8.8
- upper Limit
- 7.7
- value
- -0.6
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 37
- units
- Participants
- title
- Fatigue at Day 134
- categories
- measurements
- group Id
- OG000
- lower Limit
- -9.2
- upper Limit
- 2.3
- value
- -3.4
- group Id
- OG001
- lower Limit
- -5.6
- upper Limit
- 5.2
- value
- -0.2
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 58
- units
- Participants
- title
- Physical Functioning at Day 64
- categories
- measurements
- group Id
- OG000
- lower Limit
- -10.2
- upper Limit
- 3.2
- value
- -3.5
- group Id
- OG001
- lower Limit
- -6.0
- upper Limit
- 6.4
- value
- 0.2
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 37
- units
- Participants
- title
- Physical Functioning at Day 134
- categories
- measurements
- group Id
- OG000
- lower Limit
- -4.0
- upper Limit
- 9.0
- value
- 2.5
- group Id
- OG001
- lower Limit
- -5.0
- upper Limit
- 7.1
- value
- 1.0
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 58
- units
- Participants
- title
- Global Health Status at Day 64
- categories
- measurements
- group Id
- OG000
- lower Limit
- -6.2
- upper Limit
- 8.0
- value
- 0.9
- group Id
- OG001
- lower Limit
- -3.3
- upper Limit
- 9.5
- value
- 3.1
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 37
- units
- Participants
- title
- Global Health Status at Day 134
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 58
- units
- Participants
- description
- EORTC QLQ-C30 is a 30 item questionnaire composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, and social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health/quality of life (QOL) subscale, and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation, and the financial impact of cancer). The questionnaire employed twenty-eight 4 point Likert scales with responses from "not at all" to "very much" and two 7 point Likert scales for global health and overall QOL. For functional and global QOL scales, higher scores represented a better level of functioning and all scores were converted to a 0 to 100 scale. For symptom oriented scales, a higher score represented more severe symptoms, and all scores were converted to a 0-100 scale. Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- 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 Core Questionnaire (EORTC QLQ-C30) Score
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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