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NCT05386550 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      81
    2. group Id
      BG001
      value
      85
    3. group Id
      BG002
      value
      166
    units
    Participants
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
    BG000
    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
    BG001
    title
    Placebo + IMRT
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.89
          value
          69
        2. group Id
          BG001
          spread
          9.61
          value
          69
        3. group Id
          BG002
          spread
          9.72
          value
          69
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          39
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          127
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          18
      title
      Ethnicity-Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          124
      title
      Ethnicity-Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          23
      title
      Ethnicity-Not Reported
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Ethnicity-Unknown or Not Reported
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Race-American Indian or Alaska Native
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          85
      title
      Race-Asian
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Race-Black or African American
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Race-More than one race
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          23
      title
      Race-Unknown or Not Reported
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          55
      title
      Race-White
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      81
    2. group Id
      BG001
      value
      85
    3. group Id
      BG002
      value
      166
    units
    Participants
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
    BG000
    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
    BG001
    title
    Placebo + IMRT
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.89
          value
          69
        2. group Id
          BG001
          spread
          9.61
          value
          69
        3. group Id
          BG002
          spread
          9.72
          value
          69
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          39
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          127
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          18
      title
      Ethnicity-Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          61
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          124
      title
      Ethnicity-Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          23
      title
      Ethnicity-Not Reported
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Ethnicity-Unknown or Not Reported
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Race-American Indian or Alaska Native
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          85
      title
      Race-Asian
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Race-Black or African American
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Race-More than one race
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          23
      title
      Race-Unknown or Not Reported
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          55
      title
      Race-White
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice