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NCT01212991 · OUTCOME

Time to Initiation of Cytotoxic Chemotherapy

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

The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was 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
Enzalutamide28.0Not reported25.8NAThe 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.
Placebo10.8Not reported9.712.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.303
    ci Pct Value
    95
    ci Upper Limit
    0.403
    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
    The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0125 for this analysis.
    param Type
    Hazard Ratio (HR)
    param Value
    0.349
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.303
    ci Pct Value
    95
    ci Upper Limit
    0.403
    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
    The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0125 for this analysis.
    param Type
    Hazard Ratio (HR)
    param Value
    0.349
    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
        25.8
        upper Limit
        NA
        value
        28.0
      2. group Id
        OG001
        lower Limit
        9.7
        upper Limit
        12.2
        value
        10.8
denoms
  1. counts
    1. group Id
      OG000
      value
      872
    2. group Id
      OG001
      value
      845
    units
    Participants
description
The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was 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
Time to Initiation of Cytotoxic Chemotherapy
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice