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NCT02228681 · OUTCOME

Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Assessed throughout the treatment period and for 30 days after discontinuation of treatment. Treatment continues until progression of disease.

What was measured

Maximum grade of physician assessed adverse events graded and categorized using Common Toxicity Criteria for Adverse Events (CTCAE) version 4

Analysis population: Eligible and Treated Patients

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

Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus and Letrozole2Not reportedNot reportedNot reportedNot reported
Tamoxifen and Medroxyprogesterone Acetate2Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus and Letrozole6Not reportedNot reportedNot reportedNot reported
Tamoxifen and Medroxyprogesterone Acetate14Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus and Letrozole27Not reportedNot reportedNot reportedNot reported
Tamoxifen and Medroxyprogesterone Acetate17Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus and Letrozole2Not reportedNot reportedNot reportedNot reported
Tamoxifen and Medroxyprogesterone Acetate2Not reportedNot reportedNot reportedNot reported
Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus and Letrozole0Not reportedNot reportedNot reportedNot reported
Tamoxifen and Medroxyprogesterone Acetate1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        14
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        17
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    2. group Id
      OG001
      value
      36
    units
    Participants
description
Maximum grade of physician assessed adverse events graded and categorized using Common Toxicity Criteria for Adverse Events (CTCAE) version 4
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
COUNT_OF_PARTICIPANTS
population Description
Eligible and Treated Patients
reporting Status
POSTED
time Frame
Assessed throughout the treatment period and for 30 days after discontinuation of treatment. Treatment continues until progression of disease.
title
Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice