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NCT02283658 · OUTCOME

Confirmed Response Rate, Estimated Using RECIST 1.1 Criteria

Everolimus and Letrozole in Treating Patients With Recurrent Hormone Receptor Positive Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer · Source last updated 2020-10-23

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
Up to 24 weeks

What was measured

A confirmed tumor response is defined to be either a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. A complete response (CR) in evaluable patients will be defined as: * Disappearance of any sign of (evaluable) disease, AND * Normalization of CA-125; if CA-125 normalizes, it should be confirmed at any time. A partial response (PR) in evaluable patients will be defined as: * Decrement in CA-125 by \>50%, and * Improvement in any additional evaluable disease (if present) as assessed by the enrolling physician.

Analysis population: All evaluable patients

Groups in this outcome

Treatment (Everolimus and Letrozole)

Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Treatment (Everolimus and Letrozole)19

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Everolimus and Letrozole)16Not reported340Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        40
        value
        16
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
A confirmed tumor response is defined to be either a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. A complete response (CR) in evaluable patients will be defined as: * Disappearance of any sign of (evaluable) disease, AND * Normalization of CA-125; if CA-125 normalizes, it should be confirmed at any time. A partial response (PR) in evaluable patients will be defined as: * Decrement in CA-125 by \>50%, and * Improvement in any additional evaluable disease (if present) as assessed by the enrolling physician.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treatment (Everolimus and Letrozole)
param Type
NUMBER
population Description
All evaluable patients
reporting Status
POSTED
time Frame
Up to 24 weeks
title
Confirmed Response Rate, Estimated Using RECIST 1.1 Criteria
type
SECONDARY
unit Of Measure
percentage of patients

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice