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NCT00256698 · OUTCOME

Percentage of Evaluable Participants With Objective Response Rate (ORR)

Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy · Source last updated 2012-08-01

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

Measure
NUMBER
Unit
Percentage of evaluable participants
Interval / dispersion
Not reported
Time frame
RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009

What was measured

No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (\>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)

Groups in this outcome

Fulvestrant + Anastrozole

Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg

Anastrozole

Anastrozole 1 mg

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Fulvestrant + Anastrozole129
Anastrozole113

Reported measurements

Source class 1
Values in Percentage of evaluable participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fulvestrant + Anastrozole31.8Not reportedNot reportedNot reportedNot reported
Anastrozole33.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        31.8
      2. group Id
        OG001
        value
        33.6
denoms
  1. counts
    1. group Id
      OG000
      value
      129
    2. group Id
      OG001
      value
      113
    units
    Participants
description
No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (\>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)
groups
  1. description
    Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
    id
    OG000
    title
    Fulvestrant + Anastrozole
  2. description
    Anastrozole 1 mg
    id
    OG001
    title
    Anastrozole
param Type
NUMBER
reporting Status
POSTED
time Frame
RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
title
Percentage of Evaluable Participants With Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of evaluable participants

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

Preserved source evidence · Not medical advice