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NCT04590963 · OUTCOME

Number of Participants With Abnormal Vital Signs Reported as TEAEs

Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer · Source last updated 2026-09-09

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
Day 1 through 21.4 months (maximum observed duration)

What was measured

Participants with abnormal vital signs (heart rate, blood pressure, temperature, and respiratory rate) reported as TEAEs are reported. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first.

Analysis population: The Safety Analysis Set included all participants randomized at least 2 months before the DCO 01Sep2022 (i.e. on or before 01Jul2022).

Groups in this outcome

Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2

Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

Placebo Q2W + Cetuximab 400 mg/m^2

Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

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

Analysis denominator · Participants

GroupSource count
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2246
Placebo Q2W + Cetuximab 400 mg/m^2122

Reported measurements

Hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^24Not reportedNot reportedNot reportedNot reported
Placebo Q2W + Cetuximab 400 mg/m^24Not reportedNot reportedNot reportedNot reported
Hypotension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^211Not reportedNot reportedNot reportedNot reported
Placebo Q2W + Cetuximab 400 mg/m^23Not reportedNot reportedNot reportedNot reported
Hypoxia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^20Not reportedNot reportedNot reportedNot reported
Placebo Q2W + Cetuximab 400 mg/m^21Not reportedNot reportedNot reportedNot reported
Hyperpyrexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^21Not reportedNot reportedNot reportedNot reported
Placebo Q2W + Cetuximab 400 mg/m^20Not reportedNot reportedNot reportedNot reported
Pyrexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^218Not reportedNot reportedNot reportedNot reported
Placebo Q2W + Cetuximab 400 mg/m^210Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
    title
    Hypertension
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        3
    title
    Hypotension
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Hypoxia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Hyperpyrexia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        10
    title
    Pyrexia
denoms
  1. counts
    1. group Id
      OG000
      value
      246
    2. group Id
      OG001
      value
      122
    units
    Participants
description
Participants with abnormal vital signs (heart rate, blood pressure, temperature, and respiratory rate) reported as TEAEs are reported. TEAEs included events from the first dose of study drug, up to 90 days after the last dose of study drug received or up to the start date of any subsequent anticancer therapy following discontinuation of study drug, or the final safety DCO date of 01Sep2022, whichever occurred first.
groups
  1. description
    Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
    id
    OG000
    title
    Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
  2. description
    Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
    id
    OG001
    title
    Placebo Q2W + Cetuximab 400 mg/m^2
param Type
COUNT_OF_PARTICIPANTS
population Description
The Safety Analysis Set included all participants randomized at least 2 months before the DCO 01Sep2022 (i.e. on or before 01Jul2022).
reporting Status
POSTED
time Frame
Day 1 through 21.4 months (maximum observed duration)
title
Number of Participants With Abnormal Vital Signs Reported as TEAEs
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice