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NCT00638690 · OUTCOME

Radiographic Progression-free Survival

Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy · Source last updated 2014-04-30

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
Up to 11 months

What was measured

Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be \>=2.0 cm to be considered a target lesion; progression on bone scans with \>=2 new lesions not consistent with tumor flare, confirmed on a second scan \>=6 weeks later that shows \>=1 additional new lesion.

Analysis population: Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.

Groups in this outcome

Abiraterone Acetate

Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.

Placebo

Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.

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 Acetate797
Placebo398

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Abiraterone Acetate171.0Not reported169.0192.0Not reported
Placebo110.0Not reported88.0168.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.585
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.776
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    The nominal P-value = 0.05.
    param Type
    Hazard Ratio (HR)
    param Value
    0.673
    statistical Comment
    This was a stratified analysis.
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.585
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.776
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    The nominal P-value = 0.05.
    param Type
    Hazard Ratio (HR)
    param Value
    0.673
    statistical Comment
    This was a stratified analysis.
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        169.0
        upper Limit
        192.0
        value
        171.0
      2. group Id
        OG001
        lower Limit
        88.0
        upper Limit
        168.0
        value
        110.0
denoms
  1. counts
    1. group Id
      OG000
      value
      797
    2. group Id
      OG001
      value
      398
    units
    Participants
description
Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be \>=2.0 cm to be considered a target lesion; progression on bone scans with \>=2 new lesions not consistent with tumor flare, confirmed on a second scan \>=6 weeks later that shows \>=1 additional new lesion.
dispersion Type
95% Confidence Interval
groups
  1. description
    Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
    id
    OG000
    title
    Abiraterone Acetate
  2. description
    Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
Analysis was performed on the Intent-to-Treat (ITT) population. The ITT population is composed of all patients randomized into the study and who will be classified according to their assigned teatment group, regardless of the actual treatment received.
reporting Status
POSTED
time Frame
Up to 11 months
title
Radiographic Progression-free Survival
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice