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NCT02069093 · OUTCOME

Median Number of Mouthwashes Per Day

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
MEDIAN
Unit
Number of mouthwashes
Interval / dispersion
Full Range
Time frame
56 days

What was measured

The median number of mouthwashes per day was assessed.

Analysis population: FAS: The FAS set consisted 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).

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

Source class 1
Values in Number of mouthwashes · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dexamethasone Based Mouthwash3.95Not reported1.94.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        4.0
        value
        3.95
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    units
    Participants
description
The median number of mouthwashes per day was assessed.
dispersion Type
Full Range
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
MEDIAN
population Description
FAS: The FAS set consisted 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).
reporting Status
POSTED
time Frame
56 days
title
Median Number of Mouthwashes Per Day
type
SECONDARY
unit Of Measure
Number of mouthwashes

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

Preserved source evidence · Not medical advice