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NCT02228681 · OUTCOME

Frequency of Response

Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer · Source last updated 2024-09-19

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

Measure
NUMBER
Unit
Number of participants
Interval / dispersion
Not reported
Time frame
From date of randomization until the date of first documented progression or date of death , up to 3 years.

What was measured

A confirmed complete or partial response as defined by RECIST 1.1 was considered a response. "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Analysis population: Eligible and treated participants. One participant in arm II was not treated. Participant flow contains all eligible participants.

Groups in this outcome

Everolimus and Letrozole

Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.

Tamoxifen and Medroxyprogesterone Acetate

Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.

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 and Letrozole37
Tamoxifen and Medroxyprogesterone Acetate36

Reported measurements

Source class 1
Values in Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus and Letrozole9Not reportedNot reportedNot reportedNot reported
Tamoxifen and Medroxyprogesterone Acetate8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    2. group Id
      OG001
      value
      36
    units
    Participants
description
A confirmed complete or partial response as defined by RECIST 1.1 was considered a response. "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
groups
  1. description
    Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.
    id
    OG000
    title
    Everolimus and Letrozole
  2. description
    Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
    id
    OG001
    title
    Tamoxifen and Medroxyprogesterone Acetate
param Type
NUMBER
population Description
Eligible and treated participants. One participant in arm II was not treated. Participant flow contains all eligible participants.
reporting Status
POSTED
time Frame
From date of randomization until the date of first documented progression or date of death , up to 3 years.
title
Frequency of Response
type
PRIMARY
unit Of Measure
Number of participants

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

Preserved source evidence · Not medical advice