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NCT01715285 · OUTCOME

Time to Initiation of Chemotherapy

A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC) · Source last updated 2025-02-04

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
Up to 66 months

What was measured

Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.

Analysis population: ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.

Groups in this outcome

Abiraterone Acetate+Prednisone+ADT

Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.

Placebo + ADT

Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.

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

Analysis denominator · Participants

GroupSource count
Abiraterone Acetate+Prednisone+ADT597
Placebo + ADT602

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Abiraterone Acetate+Prednisone+ADTNANot reported62.62NAHere, 'NA' indicates that the median and upper limit of 95% CI was not estimated due to lesser number of events.
Placebo + ADT57.59Not reported38.18NAHere, 'NA' indicates that the upper limit of 95% CI was not estimated due to lesser number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Here, 'NA' indicates that the median and upper limit of 95% CI was not estimated due to lesser number of events.
        group Id
        OG000
        lower Limit
        62.62
        upper Limit
        NA
        value
        NA
      2. comment
        Here, 'NA' indicates that the upper limit of 95% CI was not estimated due to lesser number of events.
        group Id
        OG001
        lower Limit
        38.18
        upper Limit
        NA
        value
        57.59
denoms
  1. counts
    1. group Id
      OG000
      value
      597
    2. group Id
      OG001
      value
      602
    units
    Participants
description
Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
    id
    OG000
    title
    Abiraterone Acetate+Prednisone+ADT
  2. description
    Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
    id
    OG001
    title
    Placebo + ADT
param Type
MEDIAN
population Description
ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.
reporting Status
POSTED
time Frame
Up to 66 months
title
Time to Initiation of Chemotherapy
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice