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NCT06056310 · OUTCOME

Absolute Estimated Glomerular Filtration Rate (eGFR) Values

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.

Measure
MEAN
Unit
mL/min/1.73 m^2
Interval / dispersion
Standard Deviation
Time frame
At Cycle1 Day 4 (C1D4), C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks)

What was measured

eGFR creatinine was evaluated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Absolute values in eGFR was presented. Here, mL/min/1.73 m\^2 is defined as milliliters per minute per 1.73 square meters.

Analysis population: SAS included all participants who were administered any dose of any study intervention. Here" overall number of participants analyzed signified" participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

Groups in this outcome

Sequence 1

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).

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

Analysis denominator · Participants

GroupSource count
Sequence 117

Reported measurements

C1D4

Analysis denominator · Participants

GroupSource count
Sequence 117
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 183.208017.72417Not reportedNot reportedNot reported
C1D11

Analysis denominator · Participants

GroupSource count
Sequence 116
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 183.367815.16465Not reportedNot reportedNot reported
C1D18

Analysis denominator · Participants

GroupSource count
Sequence 115
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 185.046115.67478Not reportedNot reportedNot reported
C2D1

Analysis denominator · Participants

GroupSource count
Sequence 116
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 193.413614.57590Not reportedNot reportedNot reported
C2D4

Analysis denominator · Participants

GroupSource count
Sequence 113
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 183.491114.94634Not reportedNot reportedNot reported
C2D11

Analysis denominator · Participants

GroupSource count
Sequence 115
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 181.613517.53286Not reportedNot reportedNot reported
C2D18

Analysis denominator · Participants

GroupSource count
Sequence 113
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 185.115516.14240Not reportedNot reportedNot reported
C3D1

Analysis denominator · Participants

GroupSource count
Sequence 116
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 187.116912.80356Not reportedNot reportedNot reported
C3D4

Analysis denominator · Participants

GroupSource count
Sequence 113
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 182.890017.87483Not reportedNot reportedNot reported
C4D1

Analysis denominator · Participants

GroupSource count
Sequence 17
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 190.034315.56475Not reportedNot reportedNot reported
C5D1

Analysis denominator · Participants

GroupSource count
Sequence 15
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 190.000013.74773Not reportedNot reportedNot reported
C6D1

Analysis denominator · Participants

GroupSource count
Sequence 12
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 169.500014.84924Not reportedNot reportedNot reported
End of treatment

Analysis denominator · Participants

GroupSource count
Sequence 117
Values in mL/min/1.73 m^2 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sequence 187.193718.00761Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.72417
        value
        83.2080
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    C1D4
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.16465
        value
        83.3678
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    C1D11
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.67478
        value
        85.0461
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    C1D18
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.57590
        value
        93.4136
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    C2D1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.94634
        value
        83.4911
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    C2D4
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.53286
        value
        81.6135
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    C2D11
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.14240
        value
        85.1155
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    C2D18
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.80356
        value
        87.1169
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    C3D1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.87483
        value
        82.8900
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    C3D4
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.56475
        value
        90.0343
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    C4D1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.74773
        value
        90.0000
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    C5D1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.84924
        value
        69.5000
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    C6D1
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
eGFR creatinine was evaluated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Absolute values in eGFR was presented. Here, mL/min/1.73 m\^2 is defined as milliliters per minute per 1.73 square meters.
dispersion Type
Standard Deviation
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
    OG000
    title
    Sequence 1
param Type
MEAN
population Description
SAS included all participants who were administered any dose of any study intervention. Here" overall number of participants analyzed signified" participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.
reporting Status
POSTED
time Frame
At Cycle1 Day 4 (C1D4), C1D11, C1D18, C2D1, C2D4, C2D11, C2D18, C3D1, C3D4, C4D1, C5D1, C6D1 and End of treatment (Day 134) (each cycle is of 3 weeks)
title
Absolute Estimated Glomerular Filtration Rate (eGFR) Values
type
SECONDARY
unit Of Measure
mL/min/1.73 m^2

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Preserved source evidence · Not medical advice