NCT00005947 · OUTCOME

Time to Objective Disease Progression

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy · Source last updated 2010-11-01

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

Measure: MEDIAN
Unit: Weeks
Interval / dispersion: 95% Confidence Interval
Time frame: 36 months from randomization

What was measured

The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).

Analysis population: all randomized participants

Groups in this outcome

Sipuleucel-T

All subjects randomized to receive sipuleucel-T.

Placebo

All subjects randomized to receive placebo

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
Sipuleucel-T	82
Placebo	45

Reported measurements

Source class 1

Values in Weeks · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Sipuleucel-T	11.7	Not reported	9.1	16.6	Not reported
Placebo	10.0	Not reported	8.7	13.1	Not reported

Source statistical analyses

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

ci Lower Limit
0.99
ci Pct Value
95
ci Upper Limit
2.11
estimate Comment
Obtained from a Cox proportional hazards model with treatment group as the independent variable \[placebo/sipuleucel-T\].
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.052
param Type
Hazard Ratio (HR)
param Value
1.45
statistical Method
Log Rank
tested Non Inferiority
false
ci Lower Limit
0.47
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.01
estimate Comment
Obtained from a Cox proportional hazards model with treatment group as the independent variable \[sipuleucel-T/placebo\]
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.052
param Type
Hazard Ratio (HR)
param Value
0.69
statistical Method
Log Rank
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
0.99
ci Pct Value
95
ci Upper Limit
2.11
estimate Comment
Obtained from a Cox proportional hazards model with treatment group as the independent variable \[placebo/sipuleucel-T\].
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.052
param Type
Hazard Ratio (HR)
param Value
1.45
statistical Method
Log Rank
tested Non Inferiority
false
ci Lower Limit
0.47
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.01
estimate Comment
Obtained from a Cox proportional hazards model with treatment group as the independent variable \[sipuleucel-T/placebo\]
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.052
param Type
Hazard Ratio (HR)
param Value
0.69
statistical Method
Log Rank
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
lower Limit
9.1
upper Limit
16.6
value
11.7
group Id
OG001
lower Limit
8.7
upper Limit
13.1
value
10.0

denoms

counts
group Id
OG000
value
82
group Id
OG001
value
45
units
Participants

description

The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).

dispersion Type

95% Confidence Interval

groups

description
All subjects randomized to receive sipuleucel-T.
id
OG000
title
Sipuleucel-T
description
All subjects randomized to receive placebo
id
OG001
title
Placebo

param Type

MEDIAN

population Description

all randomized participants

reporting Status

POSTED

time Frame

36 months from randomization

title

Time to Objective Disease Progression

type

PRIMARY

unit Of Measure

Weeks

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Preserved source evidence · Not medical advice