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NCT00248170 · OUTCOME

Disease Free Survival

Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer · Source last updated 2016-04-19

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
84 months

What was measured

Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.

Analysis population: Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

Groups in this outcome

Letrozole

2.5 mg by mouth (p.o.) once daily

Anastrozole

1 mg p.o. once 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
Letrozole2061
Anastrozole2075

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
LetrozoleNANot reported84.14NAThe median was not reached and therefore, could not be calculated.
AnastrozoleNANot reportedNANAThe median was not reached and therefore, could not be calculated.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3150
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3150
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. comment
        The median was not reached and therefore, could not be calculated.
        group Id
        OG000
        lower Limit
        84.14
        upper Limit
        NA
        value
        NA
      2. comment
        The median was not reached and therefore, could not be calculated.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      2061
    2. group Id
      OG001
      value
      2075
    units
    Participants
description
Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    2.5 mg by mouth (p.o.) once daily
    id
    OG000
    title
    Letrozole
  2. description
    1 mg p.o. once daily
    id
    OG001
    title
    Anastrozole
param Type
MEDIAN
population Description
Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.
reporting Status
POSTED
time Frame
84 months
title
Disease Free Survival
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice