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NCT02990468 · OUTCOME

Incidence of Radiation-induced Xerostomia by Unstimulated Saliva Production

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
gram
Interval / dispersion
Standard Deviation
Time frame
6 months

What was measured

Xerostomia will also be assessed by measurement of unstimulated saliva production post treatment.

Analysis population: one subject in group 3 did not complete follow up and was excluded from analysis

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 12
Phase 1: Group II2
Phase 2: Group III22

Reported measurements

Source class 1
Values in gram · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 1: Group 10.420.041Not reportedNot reportedNot reported
Phase 1: Group II1.0900.334Not reportedNot reportedNot reported
Phase 2: Group III1.2550.932Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.041
        value
        0.42
      2. group Id
        OG001
        spread
        0.334
        value
        1.090
      3. group Id
        OG002
        spread
        0.932
        value
        1.255
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      22
    units
    Participants
description
Xerostomia will also be assessed by measurement of unstimulated saliva production post treatment.
dispersion Type
Standard Deviation
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
one subject in group 3 did not complete follow up and was excluded from analysis
reporting Status
POSTED
time Frame
6 months
title
Incidence of Radiation-induced Xerostomia by Unstimulated Saliva Production
type
SECONDARY
unit Of Measure
gram

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

Preserved source evidence · Not medical advice