NCT06056310 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)

What was measured

AEs were defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs were defined as AEs emerging or worsening after start of treatment until 30 days after end of treatment. Adverse events were coded according to the latest available version of the Medical Dictionary for Regulatory Activities (MedDRA). Treatment-Related TEAEs was defined as any AE considered as related to study treatment.

Analysis population: Safety analysis set (SAS) included all participants who were administered any dose of any study intervention.

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

Group	Source count
Sequence 1	18

Reported measurements

TEAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Sequence 1	18	Not reported	Not reported	Not reported	Not reported

Treatment Related TEAEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Sequence 1	18	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
18
title
TEAEs
categories
measurements
group Id
OG000
value
18
title
Treatment Related TEAEs

denoms

counts
group Id
OG000
value
18
units
Participants

description

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. 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

COUNT_OF_PARTICIPANTS

population Description

Safety analysis set (SAS) included all participants who were administered any dose of any study intervention.

reporting Status

POSTED

time Frame

Screening up to end of treatment (Day 134) and then follow up every 3 months (assessed up to maximum 6 months)

title

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice