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NCT00382070 · OUTCOME

Arterial Thrombotic Events

Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer · Source last updated 2024-03-22

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
Not reported
Time frame
7 years

What was measured

Cumulative incidence of arterial thrombotic events, as defined by CTCAE version 4.0 (grade ≥1 stroke or transient ischaemic attack; grade ≥2 acute coronary syndrome or cerebrovascular ischaemia; grade ≥3 myocardial infarction, peripheral ischaemia, or visceral arterial ischaemia; and grade ≥4 selected thromboembolic events \[cerebrovascular event, arterial insufficiency\]).

Groups in this outcome

Group 2 Letrozole

Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years

Group 1 Placebo

Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years

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

Analysis denominator · Participants

GroupSource count
Group 2 Letrozole1950
Group 1 Placebo1953

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 2 Letrozole4.0Not reportedNot reportedNot reportedNot reported
Group 1 Placebo3.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4.0
      2. group Id
        OG001
        value
        3.4
denoms
  1. counts
    1. group Id
      OG000
      value
      1950
    2. group Id
      OG001
      value
      1953
    units
    Participants
description
Cumulative incidence of arterial thrombotic events, as defined by CTCAE version 4.0 (grade ≥1 stroke or transient ischaemic attack; grade ≥2 acute coronary syndrome or cerebrovascular ischaemia; grade ≥3 myocardial infarction, peripheral ischaemia, or visceral arterial ischaemia; and grade ≥4 selected thromboembolic events \[cerebrovascular event, arterial insufficiency\]).
groups
  1. description
    Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years
    id
    OG000
    title
    Group 2 Letrozole
  2. description
    Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
    id
    OG001
    title
    Group 1 Placebo
param Type
NUMBER
reporting Status
POSTED
time Frame
7 years
title
Arterial Thrombotic Events
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice