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NCT00863655 · OUTCOME

Estradiol Plasma Concentrations

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
pg/mL
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 4

What was measured

Compare estradiol concentrations from baseline to week 4 in both treatment arms.

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

Placebo + Exemestane

Placebo of everolimus 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

GroupSource count
Everolimus + Exemestane41
Placebo + Exemestane15

Reported measurements

Baseline (n: = 41, 14)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus + Exemestane5.623.3421.001.00Not reported
Placebo + Exemestane4.091.792NANANot reported
Week 4 (n: 38, 15)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus + Exemestane3.502.5510.680.94Not reported
Placebo + Exemestane5.176.919NANANot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        spread
        3.342
        upper Limit
        1.00
        value
        5.62
      2. group Id
        OG001
        lower Limit
        NA
        spread
        1.792
        upper Limit
        NA
        value
        4.09
    title
    Baseline (n: = 41, 14)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.68
        spread
        2.551
        upper Limit
        0.94
        value
        3.50
      2. group Id
        OG001
        lower Limit
        NA
        spread
        6.919
        upper Limit
        NA
        value
        5.17
    title
    Week 4 (n: 38, 15)
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      15
    units
    Participants
description
Compare estradiol concentrations from baseline to week 4 in both treatment arms.
dispersion Type
Standard Deviation
groups
  1. description
    Everolimus 10 mg daily in combination with exemestane 25 mg daily
    id
    OG000
    title
    Everolimus + Exemestane
  2. description
    Placebo of everolimus in combination with exemestane 25 mg daily
    id
    OG001
    title
    Placebo + 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
Baseline, Week 4
title
Estradiol Plasma Concentrations
type
SECONDARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice