Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00295750 · OUTCOME

The Mean Value of QTc Interval as Measured by Electrocardiogram

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
milliseconds
Interval / dispersion
Standard Deviation
Time frame
12 months

What was measured

The QTc interval results are calculated with Fridericia's correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias.

Analysis population: ITT population. End of Study values obtained at day 364 (+-7 days) for patients who completed. Patients who withdrew early had variable timeframes for the end of study value.

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

Baseline Day 0 (n=202, 207, 201)
Values in milliseconds · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg40320.2Not reportedNot reportedNot reported
Degarelix 240/80 mg40721.6Not reportedNot reportedNot reported
Leuprolide 7.5 mg40419.4Not reportedNot reportedNot reported
Day 3 (n=195, 204, 197)
Values in milliseconds · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg40422.1Not reportedNot reportedNot reported
Degarelix 240/80 mg41123.5Not reportedNot reportedNot reported
Leuprolide 7.5 mg40523.0Not reportedNot reportedNot reported
End of study 12 months (n=202, 207, 201)
Values in milliseconds · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Degarelix 240/160 mg41521.7Not reportedNot reportedNot reported
Degarelix 240/80 mg42022.3Not reportedNot reportedNot reported
Leuprolide 7.5 mg41923.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.2
        value
        403
      2. group Id
        OG001
        spread
        21.6
        value
        407
      3. group Id
        OG002
        spread
        19.4
        value
        404
    title
    Baseline Day 0 (n=202, 207, 201)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.1
        value
        404
      2. group Id
        OG001
        spread
        23.5
        value
        411
      3. group Id
        OG002
        spread
        23.0
        value
        405
    title
    Day 3 (n=195, 204, 197)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.7
        value
        415
      2. group Id
        OG001
        spread
        22.3
        value
        420
      3. group Id
        OG002
        spread
        23.3
        value
        419
    title
    End of study 12 months (n=202, 207, 201)
denoms
  1. counts
    1. group Id
      OG000
      value
      202
    2. group Id
      OG001
      value
      207
    3. group Id
      OG002
      value
      201
    units
    Participants
description
The QTc interval results are calculated with Fridericia's correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias.
dispersion Type
Standard Deviation
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. End of Study values obtained at day 364 (+-7 days) for patients who completed. Patients who withdrew early had variable timeframes for the end of study value.
reporting Status
POSTED
time Frame
12 months
title
The Mean Value of QTc Interval as Measured by Electrocardiogram
type
SECONDARY
unit Of Measure
milliseconds

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

Preserved source evidence · Not medical advice