NCT00638690 · OUTCOME

Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%

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: NUMBER
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 12 months

What was measured

A prostate-specific antigen (PSA) response was defined as a \>=50% decline from baseline.

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

Group	Source count
Abiraterone Acetate	797
Placebo	398

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Abiraterone Acetate	232	Not reported	Not reported	Not reported	Not reported
Placebo	22	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
3.459
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
8.018
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
p Value Comment
Nominal P-value = 0.05.
param Type
Risk Ratio (RR)
param Value
5.266
statistical Method
Chi-squared
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
3.459
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
8.018
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
p Value Comment
Nominal P-value = 0.05.
param Type
Risk Ratio (RR)
param Value
5.266
statistical Method
Chi-squared
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
value
232
group Id
OG001
value
22

denoms

counts
group Id
OG000
value
797
group Id
OG001
value
398
units
Participants

description

A prostate-specific antigen (PSA) response was defined as a \>=50% decline from baseline.

groups

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
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

NUMBER

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 12 months

title

Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice