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NCT02200614 · OUTCOME

Time to First Symptomatic Skeletal Event (SSE) - Final Analysis

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer · Source last updated 2022-06-28

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until occurrence of first SSE event (approximately 59 months)

What was measured

The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE. The final analysis was done at the time of the data cut-off (15 NOV 2019).

Groups in this outcome

Darolutamide (BAY1841788)

Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).

Placebo

Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).

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

Analysis denominator · Participants

GroupSource count
Darolutamide (BAY1841788)955
Placebo554

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Darolutamide (BAY1841788)NANot reportedNANANA = value cannot be estimated due to censored data, insufficient number of participants with events
PlaceboNANot reportedNANANA = value cannot be estimated due to censored data, insufficient number of participants with events

Source statistical analyses

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

  1. ci Lower Limit
    0.287
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.815
    estimate Comment
    The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.005294
    param Type
    Hazard Ratio (HR)
    param Value
    0.484
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.287
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.815
    estimate Comment
    The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.005294
    param Type
    Hazard Ratio (HR)
    param Value
    0.484
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA = value cannot be estimated due to censored data, insufficient number of participants with events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        NA = value cannot be estimated due to censored data, insufficient number of participants with events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      955
    2. group Id
      OG001
      value
      554
    units
    Participants
description
The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE. The final analysis was done at the time of the data cut-off (15 NOV 2019).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
    id
    OG000
    title
    Darolutamide (BAY1841788)
  2. description
    Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
    id
    OG001
    title
    Placebo
param Type
MEDIAN
reporting Status
POSTED
time Frame
From randomization until occurrence of first SSE event (approximately 59 months)
title
Time to First Symptomatic Skeletal Event (SSE) - Final Analysis
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice