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NCT01212991 · OUTCOME

Overall Survival

A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer · Source last updated 2020-03-17

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
During study period (up to 3 years)

What was measured

Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.

Analysis population: Intent to Treat (ITT) - All patients randomly assigned to treatment.

Groups in this outcome

Enzalutamide

Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.

Placebo

Participants received placebo, administered as four capsules, once per day by mouth.

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

Analysis denominator · Participants

GroupSource count
Enzalutamide872
Placebo845

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Enzalutamide32.4Not reported30.1NAThe upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
Placebo30.2Not reported28.0NAThe upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

Source statistical analyses

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

  1. ci Lower Limit
    0.596
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.837
    estimate Comment
    The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \<1 favoring enzalutamide.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    p Value Comment
    A 2-stage group sequential method (Lan DeMets OBF) assigned the level of significance for the pre-specified interim overall survival analysis (p\<0.015) based on overall 2-sided type I error rate of 0.049. Final results based upon interim analysis.
    param Type
    Hazard Ratio (HR)
    param Value
    0.706
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.596
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.837
    estimate Comment
    The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \<1 favoring enzalutamide.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    p Value Comment
    A 2-stage group sequential method (Lan DeMets OBF) assigned the level of significance for the pre-specified interim overall survival analysis (p\<0.015) based on overall 2-sided type I error rate of 0.049. Final results based upon interim analysis.
    param Type
    Hazard Ratio (HR)
    param Value
    0.706
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
        group Id
        OG000
        lower Limit
        30.1
        upper Limit
        NA
        value
        32.4
      2. comment
        The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
        group Id
        OG001
        lower Limit
        28.0
        upper Limit
        NA
        value
        30.2
denoms
  1. counts
    1. group Id
      OG000
      value
      872
    2. group Id
      OG001
      value
      845
    units
    Participants
description
Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
    id
    OG000
    title
    Enzalutamide
  2. description
    Participants received placebo, administered as four capsules, once per day by mouth.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
Intent to Treat (ITT) - All patients randomly assigned to treatment.
reporting Status
POSTED
time Frame
During study period (up to 3 years)
title
Overall Survival
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice