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NCT02069093 · OUTCOME

Dose Intensity of Everolimus and Exemestane

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
mg/day
Interval / dispersion
Full Range
Time frame
56 days

What was measured

The dose intensity was calculated as the cumulative dose of everolimus or exemestane divided by the length of time on treatment during the first 56 days of treatment.

Analysis population: FAS: The FAS 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

Everolimus
Values in mg/day · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dexamethasone Based Mouthwash10.0Not reported310Not reported
Exemestane
Values in mg/day · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dexamethasone Based Mouthwash25.0Not reported825Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        10
        value
        10.0
    title
    Everolimus
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8
        upper Limit
        25
        value
        25.0
    title
    Exemestane
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    units
    Participants
description
The dose intensity was calculated as the cumulative dose of everolimus or exemestane divided by the length of time on treatment during the first 56 days of treatment.
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 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
Dose Intensity of Everolimus and Exemestane
type
SECONDARY
unit Of Measure
mg/day

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

Preserved source evidence · Not medical advice