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NCT02990468 · OUTCOME

Duration of Radiation-induced Mucositis

A Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer · Source last updated 2023-03-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
days
Interval / dispersion
Standard Error
Time frame
6 month 6 months

What was measured

Mucositis will be scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Duration of Oral Mucositis WHO Grade 3 or higher measured as the days of severe oral mucositis.

Analysis population: only the patients that had mucositis were evaluated for duration

Groups in this outcome

Phase 1: Group 1

Subjects were administered a 7 mg loading dose subcutaneously followed by a 3.5 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.

Phase 1: Group II

Subjects were administered a 14 mg loading dose subcutaneously followed by a 7 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.

Phase 2: Group III

Subjects were administered a 28 mg loading dose subcutaneously followed by a 14 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.

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

Analysis denominator · Participants

GroupSource count
Phase 1: Group 11
Phase 1: Group II1
Phase 2: Group III10

Reported measurements

Source class 1
Values in days · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Phase 1: Group 122NANot reportedNot reportedThe sample size is too small to calculate standard error.
Phase 1: Group II18NANot reportedNot reportedThe sample size is too small to calculate standard error.
Phase 2: Group III37.48.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The sample size is too small to calculate standard error.
        group Id
        OG000
        spread
        NA
        value
        22
      2. comment
        The sample size is too small to calculate standard error.
        group Id
        OG001
        spread
        NA
        value
        18
      3. group Id
        OG002
        spread
        8.2
        value
        37.4
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      10
    units
    Participants
description
Mucositis will be scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Duration of Oral Mucositis WHO Grade 3 or higher measured as the days of severe oral mucositis.
dispersion Type
Standard Error
groups
  1. description
    Subjects were administered a 7 mg loading dose subcutaneously followed by a 3.5 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
    id
    OG000
    title
    Phase 1: Group 1
  2. description
    Subjects were administered a 14 mg loading dose subcutaneously followed by a 7 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
    id
    OG001
    title
    Phase 1: Group II
  3. description
    Subjects were administered a 28 mg loading dose subcutaneously followed by a 14 mg maintenance dose subcutaneously twice a week while on concurrent cisplatin and RT.
    id
    OG002
    title
    Phase 2: Group III
param Type
MEAN
population Description
only the patients that had mucositis were evaluated for duration
reporting Status
POSTED
time Frame
6 month 6 months
title
Duration of Radiation-induced Mucositis
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice