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NCT03085095 · OUTCOME

Percentage of Participants Who Experienced Major Adverse Cardiovascular Events (MACE)

A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer · Source last updated 2022-01-18

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)

What was measured

MACE were defined as nonfatal myocardial infarction, nonfatal stroke, and death from any cause.

Analysis population: All randomized participants who received at least 1 dose of study drug.

Groups in this outcome

Relugolix

Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.

Leuprolide Acetate

Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.

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

Analysis denominator · Participants

GroupSource count
Relugolix622
Leuprolide Acetate308

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Relugolix2.9Not reportedNot reportedNot reportedNot reported
Leuprolide Acetate6.2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2.9
      2. group Id
        OG001
        value
        6.2
denoms
  1. counts
    1. group Id
      OG000
      value
      622
    2. group Id
      OG001
      value
      308
    units
    Participants
description
MACE were defined as nonfatal myocardial infarction, nonfatal stroke, and death from any cause.
groups
  1. description
    Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
    id
    OG000
    title
    Relugolix
  2. description
    Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
    id
    OG001
    title
    Leuprolide Acetate
param Type
NUMBER
population Description
All randomized participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)
title
Percentage of Participants Who Experienced Major Adverse Cardiovascular Events (MACE)
type
OTHER_PRE_SPECIFIED
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice