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NCT02069093 · OUTCOME

Number of Participants With All Grades of Stomatitis

Open-label, Phase II Study of Stomatitis Prevention With a Steroid-based Mouthwash in Post-menopausal Women With Estrogen-receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)- Metastatic or Locally Advanced Breast Cancer · Source last updated 2017-02-13

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
56 days

What was measured

The number of participants with all grades of stomatitis was defined as the number of participants who had stomatitis grade 1 or higher. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.

Analysis population: The FAS, consisting of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash), was considered for the analysis. However, only those participants, who were evaluable for stomatitis grade, were analyzed.

Groups in this outcome

Dexamethasone Based Mouthwash

Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.

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

Analysis denominator · Participants

GroupSource count
Dexamethasone Based Mouthwash86

Reported measurements

Stomatitis all grade
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dexamethasone Based Mouthwash18Not reportedNot reportedNot reportedNot reported
Not evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dexamethasone Based Mouthwash1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Stomatitis all grade
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Not evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    units
    Participants
description
The number of participants with all grades of stomatitis was defined as the number of participants who had stomatitis grade 1 or higher. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.
groups
  1. description
    Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
    id
    OG000
    title
    Dexamethasone Based Mouthwash
param Type
NUMBER
population Description
The FAS, consisting of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash), was considered for the analysis. However, only those participants, who were evaluable for stomatitis grade, were analyzed.
reporting Status
POSTED
time Frame
56 days
title
Number of Participants With All Grades of Stomatitis
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice