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NCT00295750 · OUTCOME

Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment

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
MEAN
Unit
percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
2 weeks

What was measured

A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by \>=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).

Analysis population: ITT population. If one or more of the testosterone values on Days 1, 3, 7 or 14 was missing, the last observation was carried forward.

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

GroupSource count
Degarelix 240/160 mg202
Degarelix 240/80 mg207
Leuprolide 7.5 mg201

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg0.5Not reported0.02.7Not reported
Degarelix 240/80 mg0.0Not reported0.01.8Not reported
Leuprolide 7.5 mg80.1Not reported73.985.4Not reported

Source statistical analyses

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

  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
  2. ci Pct Value
    95
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
  2. ci Pct Value
    95
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    Fisher Exact
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        2.7
        value
        0.5
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        1.8
        value
        0.0
      3. group Id
        OG002
        lower Limit
        73.9
        upper Limit
        85.4
        value
        80.1
denoms
  1. counts
    1. group Id
      OG000
      value
      202
    2. group Id
      OG001
      value
      207
    3. group Id
      OG002
      value
      201
    units
    Participants
description
A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by \>=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
MEAN
population Description
ITT population. If one or more of the testosterone values on Days 1, 3, 7 or 14 was missing, the last observation was carried forward.
reporting Status
POSTED
time Frame
2 weeks
title
Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice