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NCT04420689 · OUTCOME

Safety - The Number of Patients With ALM-488 Related Adverse Events

Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery · Source last updated 2025-05-08

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
28 (+5) days

What was measured

The number of patients with ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Groups in this outcome

Dose Defining 100mg

This arm of the study will include ALM-488 dose 100mg ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Dose Defining 200mg

This arm of the study will include ALM-488 dose 200mg ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Dose Defining 400mg

This arm of the study will include ALM-488 dose 400mg ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Dose Defining 500mg

This arm of the study will include ALM-488 dose 500mg ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Dose Defining 600mg

This arm of the study will include ALM-488 dose 600mg ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Dose Timing 1-3hrs

This arm of the study will include ALM-488 timing of administration 1-3 hours before surgery. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Dose Timing 3-5 Hrs.

This arm of the study will include ALM-488 timing of administration 3-5 hours before surgery. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

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

Analysis denominator · Participants

GroupSource count
Dose Defining 100mg3
Dose Defining 200mg3
Dose Defining 400mg3
Dose Defining 500mg3
Dose Defining 600mg3
Dose Timing 1-3hrs6
Dose Timing 3-5 Hrs.6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Defining 100mg0Not reportedNot reportedNot reportedNot reported
Dose Defining 200mg0Not reportedNot reportedNot reportedNot reported
Dose Defining 400mg0Not reportedNot reportedNot reportedNot reported
Dose Defining 500mg0Not reportedNot reportedNot reportedNot reported
Dose Defining 600mg0Not reportedNot reportedNot reportedNot reported
Dose Timing 1-3hrs0Not reportedNot reportedNot reportedNot reported
Dose Timing 3-5 Hrs.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      6
    units
    Participants
description
The number of patients with ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
groups
  1. description
    This arm of the study will include ALM-488 dose 100mg ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG000
    title
    Dose Defining 100mg
  2. description
    This arm of the study will include ALM-488 dose 200mg ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG001
    title
    Dose Defining 200mg
  3. description
    This arm of the study will include ALM-488 dose 400mg ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG002
    title
    Dose Defining 400mg
  4. description
    This arm of the study will include ALM-488 dose 500mg ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG003
    title
    Dose Defining 500mg
  5. description
    This arm of the study will include ALM-488 dose 600mg ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG004
    title
    Dose Defining 600mg
  6. description
    This arm of the study will include ALM-488 timing of administration 1-3 hours before surgery. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG005
    title
    Dose Timing 1-3hrs
  7. description
    This arm of the study will include ALM-488 timing of administration 3-5 hours before surgery. ALM-488: ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
    id
    OG006
    title
    Dose Timing 3-5 Hrs.
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
28 (+5) days
title
Safety - The Number of Patients With ALM-488 Related Adverse Events
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice