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NCT03085095 · OUTCOME

Sustained Profound Castration Rate From Week 5 Day 1 Through Week 49 Day 1

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
95% Confidence Interval
Time frame
Week 5 Day 1 (Day 29) through Week 49 Day 1 (Day 337)

What was measured

Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.

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: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Relugolix81.6Not reported78.184.5Not reported
Leuprolide Acetate68.6Not reported63.073.5Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    6.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    19.1
    estimate Comment
    Treatment difference= Relugolix - Leuprolide acetate
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Treatment difference
    param Value
    13.0
Complete source fields
analyses
  1. ci Lower Limit
    6.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    19.1
    estimate Comment
    Treatment difference= Relugolix - Leuprolide acetate
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Treatment difference
    param Value
    13.0
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        78.1
        upper Limit
        84.5
        value
        81.6
      2. group Id
        OG001
        lower Limit
        63.0
        upper Limit
        73.5
        value
        68.6
denoms
  1. counts
    1. group Id
      OG000
      value
      622
    2. group Id
      OG001
      value
      308
    units
    Participants
description
Sustained profound castration rate was defined as the cumulative probability of testosterone suppression to \< 20 ng/dL. The rate was estimated by the Kaplan-Meier method and reported as percentage of participants.
dispersion Type
95% Confidence Interval
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
Week 5 Day 1 (Day 29) through Week 49 Day 1 (Day 337)
title
Sustained Profound Castration Rate From Week 5 Day 1 Through Week 49 Day 1
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice