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NCT06056310 · BASELINE

Baseline characteristics

Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX) · Source last updated 2025-09-29

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
      18
    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. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 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
    Sequence 1
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.19
          value
          60
    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
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        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
          1
      title
      Ethnicity-Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Ethnicity-Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Race-Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Race-Black or African American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      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
      18
    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. The first three cycles are given in combination with Cisplatin at dose of 40 milligrams per square meter (mg/m2) once daily on Cycle 1 Day 2 (C1D2, C1D9, C1D16, C2D2, C2D9, C2D16, and C3D2) With 70 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 35 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
    Sequence 1
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.19
          value
          60
    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
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        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
          1
      title
      Ethnicity-Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Ethnicity-Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Race-Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Race-Black or African American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Race-White
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice