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NCT02799602 · OUTCOME

Time to Initiation of Subsequent Antineoplastic Therapy - Number of Events

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer · Source last updated 2025-12-04

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From randomization of the first participant to the initiation of first subsequent systemic antineoplastic therapy up to 25 OCT 2021 cut-off date approximately 59 months

What was measured

Time to initiation of subsequent systemic antineoplastic therapy was defined as the time from randomization to the initiation of first subsequent systemic antineoplastic therapy. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.

Groups in this outcome

Darolutamide (BAY1841788) + Docetaxel

Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.

Placebo + Docetaxel

Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.

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) + Docetaxel651
Placebo + Docetaxel654

Reported measurements

Number (%) of patients with event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Darolutamide (BAY1841788) + Docetaxel219Not reportedNot reportedNot reportedNot reported
Placebo + Docetaxel395Not reportedNot reportedNot reportedNot reported
Number (%) of patients censored
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Darolutamide (BAY1841788) + Docetaxel432Not reportedNot reportedNot reportedNot reported
Placebo + Docetaxel259Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        219
      2. group Id
        OG001
        value
        395
    title
    Number (%) of patients with event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        432
      2. group Id
        OG001
        value
        259
    title
    Number (%) of patients censored
denoms
  1. counts
    1. group Id
      OG000
      value
      651
    2. group Id
      OG001
      value
      654
    units
    Participants
description
Time to initiation of subsequent systemic antineoplastic therapy was defined as the time from randomization to the initiation of first subsequent systemic antineoplastic therapy. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.
groups
  1. description
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    id
    OG000
    title
    Darolutamide (BAY1841788) + Docetaxel
  2. description
    Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    id
    OG001
    title
    Placebo + Docetaxel
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From randomization of the first participant to the initiation of first subsequent systemic antineoplastic therapy up to 25 OCT 2021 cut-off date approximately 59 months
title
Time to Initiation of Subsequent Antineoplastic Therapy - Number of Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice