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NCT02990468 · OUTCOME

To Examine the Impact on Radiation Dermatitis When Adding BMX-001 to Treatment

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
30 days

What was measured

To examine the impact on radiation dermatitis of BMX-001 in combination with RT and concurrent cisplatin at 30-39 Gy, 40-49 Gy, 50-59 Gy, and 60-70 Gy, the duration of radiation dermatitis, and evaluation of radiation dermatitis-related patient-reported outcomes

Analysis population: Data was not collected or analyzed

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 10
Phase 1: Group II0
Phase 2: Group III0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
To examine the impact on radiation dermatitis of BMX-001 in combination with RT and concurrent cisplatin at 30-39 Gy, 40-49 Gy, 50-59 Gy, and 60-70 Gy, the duration of radiation dermatitis, and evaluation of radiation dermatitis-related patient-reported outcomes
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
population Description
Data was not collected or analyzed
reporting Status
POSTED
time Frame
30 days
title
To Examine the Impact on Radiation Dermatitis When Adding BMX-001 to Treatment
type
SECONDARY

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

Preserved source evidence · Not medical advice