NCT00863655 · OUTCOME

Everolimus Concentrations at Week 4

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole · Source last updated 2017-05-02

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

Measure: MEAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: pre-dose, 2 hours post-dose

What was measured

Characterize the pharmacokinetics (PK) of everolimus in combination with exemestane using Cmin (pre-dose) and C2h (post-dose) at week 4 in a small group of patients.

Analysis population: Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose \& 2 hours post-dose values for the given time points were analyzed for that time point.

Groups in this outcome

Everolimus + Exemestane

Everolimus 10 mg daily in combination with exemestane 25 mg daily

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
Everolimus + Exemestane	24

Reported measurements

Pre-dose (Cmin) (n:22)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + Exemestane	16.04	9.356	Not reported	Not reported	Not reported

2 hours post-dose (C2h) (n:24)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + Exemestane	46.50	17.954	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
9.356
value
16.04
title
Pre-dose (Cmin) (n:22)
categories
measurements
group Id
OG000
spread
17.954
value
46.50
title
2 hours post-dose (C2h) (n:24)

denoms

counts
group Id
OG000
value
24
units
Participants

description

Characterize the pharmacokinetics (PK) of everolimus in combination with exemestane using Cmin (pre-dose) and C2h (post-dose) at week 4 in a small group of patients.

dispersion Type

Standard Deviation

groups

description
Everolimus 10 mg daily in combination with exemestane 25 mg daily
id
OG000
title
Everolimus + Exemestane

param Type

MEAN

population Description

Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose \& 2 hours post-dose values for the given time points were analyzed for that time point.

reporting Status

POSTED

time Frame

pre-dose, 2 hours post-dose

title

Everolimus Concentrations at Week 4

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice