Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00863655 · OUTCOME

Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 21 months

What was measured

The QLQ-C30 is composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status - QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items - no item occurs in more than 1 scale. All of the scales measures range in score from 0 to 100. A high scale score = higher response level. Thus a high score for a functional scale represents a healthy level of function, a high score for the global health status / QoL represents a high quality of life but a high score for a symptom scale / item represents a high level of symptomatology / problems. The principle for scoring these scales: 1.) Estimate the average of the items that contribute to the scale = raw score. 2.) Linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

Analysis population: All randomized patients were included in the Full Analysis Set.

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 + Exemestane485
Placebo + Exemestane239

Reported measurements

Deterioration global health status score ≥ 5%
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Exemestane4.53Not reported4.175.68Not reported
Placebo + Exemestane4.40Not reported3.585.85Not reported
Deterioration in PF domain score of ≥ 5%
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Exemestane4.83Not reported4.176.97Not reported
Placebo + Exemestane4.37Not reported2.837.00Not reported
Deterioration in EF domain score of ≥ 5%
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Exemestane6.93Not reported5.558.41Not reported
Placebo + Exemestane6.93Not reported4.177.36Not reported
Deterioration in SF domain score of ≥ 5%
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Exemestane8.34Not reported6.9310.87Not reported
Placebo + Exemestane7.03Not reported5.62NANA: Median time to definitive deterioration computed using Kaplan-Meier method.95% CIs calculated using Brookmeyer \& Crowley (1982) method. Therefore, upper boundary of 95% CI may not be estimable when median is close to the longest patient follow-up
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.17
        upper Limit
        5.68
        value
        4.53
      2. group Id
        OG001
        lower Limit
        3.58
        upper Limit
        5.85
        value
        4.40
    title
    Deterioration global health status score ≥ 5%
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.17
        upper Limit
        6.97
        value
        4.83
      2. group Id
        OG001
        lower Limit
        2.83
        upper Limit
        7.00
        value
        4.37
    title
    Deterioration in PF domain score of ≥ 5%
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.55
        upper Limit
        8.41
        value
        6.93
      2. group Id
        OG001
        lower Limit
        4.17
        upper Limit
        7.36
        value
        6.93
    title
    Deterioration in EF domain score of ≥ 5%
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.93
        upper Limit
        10.87
        value
        8.34
      2. comment
        NA: Median time to definitive deterioration computed using Kaplan-Meier method.95% CIs calculated using Brookmeyer \& Crowley (1982) method. Therefore, upper boundary of 95% CI may not be estimable when median is close to the longest patient follow-up
        group Id
        OG001
        lower Limit
        5.62
        upper Limit
        NA
        value
        7.03
    title
    Deterioration in SF domain score of ≥ 5%
denoms
  1. counts
    1. group Id
      OG000
      value
      485
    2. group Id
      OG001
      value
      239
    units
    Participants
description
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status - QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items - no item occurs in more than 1 scale. All of the scales measures range in score from 0 to 100. A high scale score = higher response level. Thus a high score for a functional scale represents a healthy level of function, a high score for the global health status / QoL represents a high quality of life but a high score for a symptom scale / item represents a high level of symptomatology / problems. The principle for scoring these scales: 1.) Estimate the average of the items that contribute to the scale = raw score. 2.) Linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
All randomized patients were included in the Full Analysis Set.
reporting Status
POSTED
time Frame
Up to 21 months
title
Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice