NCT00295750 · OUTCOME

Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28

The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer · Source last updated 2012-12-19

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

Measure: MEDIAN
Unit: percent change
Interval / dispersion: Inter-Quartile Range
Time frame: Days 14 and 28

What was measured

Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.

Analysis population: ITT population.

Groups in this outcome

Degarelix 240/160 mg

Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.

Degarelix 240/80 mg

Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.

Leuprolide 7.5 mg

Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.

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
Degarelix 240/160 mg	202
Degarelix 240/80 mg	207
Leuprolide 7.5 mg	201

Reported measurements

Day 14

Values in percent change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Degarelix 240/160 mg	-64.6	Not reported	-77.8	-40.8	Not reported
Degarelix 240/80 mg	-63.4	Not reported	-77.1	-48.4	Not reported
Leuprolide 7.5 mg	-17.9	Not reported	-35.5	-5.2	Not reported

Day 28

Values in percent change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
Degarelix 240/160 mg	-82.3	Not reported	-91.4	-68.3	Not reported
Degarelix 240/80 mg	-84.9	Not reported	-91.6	-73.2	Not reported
Leuprolide 7.5 mg	-66.7	Not reported	-81.3	-47.7	Not reported

Source statistical analyses

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

ci Pct Value
95
group Description
Percentage change from baseline to Day 14
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Pct Value
95
group Description
Percentage change from baseline to Day 14
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Pct Value
95
group Description
Percentage change from baseline to Day 28
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Pct Value
95
group Description
Percentage change from baseline to Day 28
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false

Complete source fields

analyses

ci Pct Value
95
group Description
Percentage change from baseline to Day 14
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Pct Value
95
group Description
Percentage change from baseline to Day 14
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Pct Value
95
group Description
Percentage change from baseline to Day 28
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Pct Value
95
group Description
Percentage change from baseline to Day 28
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
lower Limit
-77.8
upper Limit
-40.8
value
-64.6
group Id
OG001
lower Limit
-77.1
upper Limit
-48.4
value
-63.4
group Id
OG002
lower Limit
-35.5
upper Limit
-5.2
value
-17.9
title
Day 14
categories
measurements
group Id
OG000
lower Limit
-91.4
upper Limit
-68.3
value
-82.3
group Id
OG001
lower Limit
-91.6
upper Limit
-73.2
value
-84.9
group Id
OG002
lower Limit
-81.3
upper Limit
-47.7
value
-66.7
title
Day 28

denoms

counts
group Id
OG000
value
202
group Id
OG001
value
207
group Id
OG002
value
201
units
Participants

description

Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.

dispersion Type

Inter-Quartile Range

groups

description
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
id
OG000
title
Degarelix 240/160 mg
description
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
id
OG001
title
Degarelix 240/80 mg
description
Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
id
OG002
title
Leuprolide 7.5 mg

param Type

MEDIAN

population Description

ITT population.

reporting Status

POSTED

time Frame

Days 14 and 28

title

Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28

type

SECONDARY

unit Of Measure

percent change

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

Preserved source evidence · Not medical advice