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NCT03085095 · OUTCOME

Castration Rate At Week 3 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 3 Day 1 (Day 15)

What was measured

Castration rate was defined as the cumulative probability of testosterone suppression to \< 50 ng/dL. The rate was estimated for each treatment group using 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
Relugolix98.71Not reported97.5699.39Not reported
Leuprolide Acetate12.05Not reported8.8816.25Not reported

Source statistical analyses

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

  1. group Description
    Alpha-protected statistical analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    p Value Comment
    Statistically significance was met if p-value \< 0.05.
    statistical Comment
    Two-sided type I error rate of 0.05.
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Description
    Alpha-protected statistical analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    p Value Comment
    Statistically significance was met if p-value \< 0.05.
    statistical Comment
    Two-sided type I error rate of 0.05.
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        97.56
        upper Limit
        99.39
        value
        98.71
      2. group Id
        OG001
        lower Limit
        8.88
        upper Limit
        16.25
        value
        12.05
denoms
  1. counts
    1. group Id
      OG000
      value
      622
    2. group Id
      OG001
      value
      308
    units
    Participants
description
Castration rate was defined as the cumulative probability of testosterone suppression to \< 50 ng/dL. The rate was estimated for each treatment group using 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 3 Day 1 (Day 15)
title
Castration Rate At Week 3 Day 1
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice