NCT02069093 · OUTCOME

Blood Concentration 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: GEOMETRIC_MEAN
Unit: ng/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: 28 days (pre-dose)

What was measured

Blood samples were collected and analyzed.

Analysis population: The PK analysis set, which was a subset of the FAS, was considered for the analysis. However, only participants who had evaluable data 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

Group	Source count
Dexamethasone Based Mouthwash	50

Reported measurements

Everolimus (n=42)

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Dexamethasone Based Mouthwash	12.047	56.492	Not reported	Not reported	Not reported

Exemestane (n=48)

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Dexamethasone Based Mouthwash	0.657	234.578	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
56.492
value
12.047
title
Everolimus (n=42)
categories
measurements
group Id
OG000
spread
234.578
value
0.657
title
Exemestane (n=48)

denoms

counts
group Id
OG000
value
50
units
Participants

description

Blood samples were collected and analyzed.

dispersion Type

Geometric Coefficient of Variation

groups

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

GEOMETRIC_MEAN

population Description

The PK analysis set, which was a subset of the FAS, was considered for the analysis. However, only participants who had evaluable data were analyzed.

reporting Status

POSTED

time Frame

28 days (pre-dose)

title

Blood Concentration of Everolimus and Exemestane

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice